Study Status

On Hold
Not Enrolling

Treatment Metastatic Cancer

Lu177 Dotatate in Extensive Stage Small Cell Lung Cancer in Combo with Chemo



Treatment Metastatic Cancer

This is a first-in-human, open-label study consisting of a Screening Period, an Imaging Period, and a Treatment Period in eligible non-small lung cancer patients who are positive for the biomarker PDL-1. The Screening period lasts up to 4 weeks. The Phase 0 (Imaging Period) is used to determine if patient's tumor(s) are still positive for the biomarker, as well as radiation dosimetry with low dose 177Lu-RAD204im (for a period of up to 2 weeks following the first injection of 177Lu-RAD204im), to assess the safety of the drug. Following the 2 week safety assessment, the subject is eligible to enter Phase I (Treatment Period) with gradual dose increases of 177Lu-RAD204tr. The Treatment Period lasts up to 3 cycles every 6 weeks, with additional extension to a maximum study dose interval of 12 weeks to be approved on a case-by-case basis in discussion with study Sponsor. During the Treatment Period, subjects will be assessed for both safety and treatment response using conventional images and clinical laboratory tests.





Treatment & Imaging Metastatic Cancer

This is a first-in-human, Phase 1, non-randomized, multicenter, open-label clinical study designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of [225Ac]-FPI-2068, [111In]-FPI-2107, and FPI-2053 in metastatic and/or recurrent solid tumors (HNSCC, NSCLC, mCRC, PDAC).


A Prospective, Single-arm, Observational Clinical Study Based on 18F-FDG PET/CT to Evaluate the True Efficacy and Immune Response of PD-1 Monoclonal Antibody Combined With First-line Chemotherapy in Advanced Non-small Cell Lung Cancer

This study is a diagnostic study. Subjects were enrolled from clinical stage IIIB or IV NSCLC patients who received standard first-line chemotherapy combined with PD-1 monoclonal antibody immunotherapy and received 18F-FDG PET/CT imaging before treatment, after 2 courses of treatment, and at the time of disease progression.At the same time, the blood routine, liver and kidney function, inflammatory indexes and other laboratory data of the subjects participating in the study were collected. Based on 18F-FDG PET Ipercist standard and comprehensive laboratory indicators, the subjects were evaluated for tumor biological characteristics prediction and clinical staging, PD-1 immune efficacy monitoring and evaluation, tumor recurrence monitoring and re-staging. At the same time, the systemic immune response and immune-related adverse events during the treatment process were evaluated in order to establish a better evaluation standard and system for the comprehensive evaluation of PD-1 immunotherapy.This study plans to set the sample size as 50 cases.



Biodistribution and Kinetics of 18F-AraG in Non-Small Cell Lung Cancer Patients Before and After Immunotherapy With and Without Radiation

This study is to assess the biodistribution and kinetics of a novel T-cell imaging agent in non-small cell lung cancer patients undergoing immunotherapy with and without adjuvant radiation therapy. This study is assessing the change in kinetics that occurs in this patient population to better understand the distribution of this compound in patient disease circumstances.


Diagnostic Significance of Single Center, Open and Prospective Evaluation of <Sup>18<Sup>F-FDG PET/CT Dynamic Imaging and Genomic Sequencing in Detecting Metastatic Lesions and Differentiating Multiple Primary Lung Cancer From Intrapulmonary Metastases of Non-small Cell Lung Cancer

The purpose of this study is to evaluate the diagnostic value of 18F-FDG PET/CT dynamic imaging in metastasis of non-small cell lung cancer (NSCLC). The investigators will collect dynamic 18F-FDG PET/CT scan and correlate the imaging findings with genomics and histopathological features of biopsy of primary or / and metastatic lesions in patients with newly diagnosed non-small cell lung cancer (NSCLC). At the same time, the investigators will evaluate the diagnostic value of 18F-FDG PET/CT dynamic imaging in differentiating multiple primary lung cancer from intrapulmonary metastases.


A Phase 1 Open-Label Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, and Preliminary Efficacy of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors

A Phase 1 SAD/MAD dose escalation and expansion study to determine the safety and effectiveness of ²¹²Pb-DOTAM-GRPR1 in subjects with various GRPR-expressing Tumors


Evaluation of the Fractional Uptake Rate (FUR) in 18F-FDG PET/CT to Assess Tumour Metabolic Activity

The goal of this study is to evaluate the use of new method to quantify the amount of sugar a tumor consumes using PET/CT. The main questions it aims to answer are: Is the new quantification method superior with respect to the method currently used in the clinic? Does the new quantification method provide accurate assessment of the sugar consumption of tumours? Participants who will undergo a standard care FDG PET/CT scan will in additional receive a dynamic PET/CT scan prior to the standard care scan. In addition blood samples will be drawn at three time points during the examination.


68Ga-NOTA-3P-TATE-RGD for Dual Somatostatin Receptor and Integrin αvβ3 PET/CT Imaging of Lung Cancer and Neuroendocrine Neoplams

This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluate the efficacy of 68Ga-NOTA-3PTATE-RGD in lung cancer patients and neuroendocrine neoplam patients. A single dose of 111-185 Mega-Becquerel (MBq) 68Ga-NOTA-3P-TATE-RGD will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.


An Open Label Phase I PET Imaging Study to Investigate the Bio-distribution and Tumor Uptake of [89Zr]Zr-BI 765063 and [89Zr]Zr-BI 770371 in Patients With Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer or Melanoma Who Are Treated With Ezabenlimab

The purpose of this study is to find out how 2 medicines called BI 765063 and BI 770371 are taken up in the tumours and how they get distributed in the body. In addition to BI 765063 or BI 770371, participants also receive ezabenlimab. BI 765063, BI 770371 and ezabenlimab are antibodies that may help the immune system fight cancer. Such therapies are also called immune checkpoint inhibitors. Participants get either BI 765063 or BI 770371 in combination with ezabenlimab as an infusion into a vein every 3 weeks. In the first weeks, doctors check how BI 765063 and BI 770371 are taken up in tumours. To do so, the doctors use imaging methods (PET/CT scans). For this, participants get BI 765063 or BI 770371 injected in a labelled form up to 2 times.


Prospective non-randomized, multi-center, diagnostic performance study of 18FDG PET for identification of early tumor escape to immunotherapy in patients with unresectable melanoma or Broncho-Pulmonary Carcinoma No to Advanced or Metastatic Small Cells

The hypothesis of this diagnostic performance study is that, for patients treated for immunotherapy-treated melanoma or NSCLC, some metabolic parameters of the 18FDG dual-point PET scan distinguish inflammatory pseudo-progression from tumor progression true and thus improve the evaluation of tumor response to immunotherapy


Evaluation of PET Probe [68Ga]CBP8 in the Detection of Radiation Induced Tissue Injury

The goal of this study is to investigate the efficacy of [68Ga]CBP8 to detect collagen deposition in radiation induced tissue injury.


The Role of 18F-FDG PET/CT in the Early Prediction of Cachexia in Lung Cancer Patients

This prospective observational study aims to investigate the relationship between cancer cachexia, stress levels, and metabolic changes in 150 lung cancer patients. Cancer cachexia, characterized by weight loss and muscle wasting, significantly impacts patient outcomes. Psychological stress is thought to contribute to cachexia development. Assessments will include medical history, physical examinations, laboratory tests, and imaging. Cancer cachexia will be diagnosed based on weight loss, reduced food intake, and inflammation markers. Psychological stress will be evaluated using questionnaires and biomarkers. Metabolic changes will be assessed using positron emission tomography-computed tomography (PET-CT) scans. The primary objective is to determine differences in metabolic activity between cachectic and non-cachectic patients. Secondary objectives include evaluating changes in brain activity and exploring the relationship between stress, inflammation, and metabolism.


Positron-Emission Tomography Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cancer

The phase I/II trial assess the safety and efficacy of a new positron emission tomography (PET) test for early diagnosis of lung cancer. This study uses PET and Me-4FDG new glucose tracer (alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside) designed specifically to determine glucose update into cells in the body. PET is a non-invasive imaging method used to detect cancer in patient. Me4FDG is a radioactive glucose tracer used in PET to locate cells in the body taking up glucose by SGLT2. SLGT2 is a sodium glucose transport protein that accumulates glucose in some cells, e.g. kidney cells and tumors. This study may help researcher determine how effective PET with ME4FDG tracer works in detecting lung cancer.


Local Ablative Stereotactic Radiotherapy for Residual Hypermetabolic Lesion in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Long-term Responders to Immunotherapy : a Randomized, Multicenter, Open-label Phase III Study

At present, it is recommended to continue immunotherapy until progression or unacceptable toxicity. However, only a minority of patients benefits from a durable response and most see the disease progress despite several months of control under immunotherapy. Multimodal approaches have been developed to improve their prognosis. This study, randomized, open-label study aims to evaluate the impact of addition of ablative radiotherapy on OS of patients with NSCLC and oligometastatic lesions and treated by immunotherapy in first line (potentially associated with chemotherapy) or beyond. Stereotactic radiotherapy will be performed on a maximum of 5 residual hypermetabolic lesions seen on 18F-FDG PET / CT, in patients responding to immunotherapy (or with a stable disease) for at least 6 months.


18F-PD-L1 PET/CT to Predict Response to Nivolumab in Patients With NSCLC

A multicenter single arm biomarker exploration and validation study. Eighty patients with NSCLC that are eligible for first line chemo-immunotherapy, first line nivolumab/ipilimumab or 2nd line and beyond PD-(L)1 immunotherapy monotherapy according to EMA label and national guidelines will be enrolled in this trial. All subjects will undergo a whole body 18F-PD-L1 PET/CT scan before start of nivolumab containing treatment. Patients will continue treatment until disease progression, withdrawal of patient consent or unacceptable toxicity.


Phase 1b Single Arm, Open-label Trial of RYZ101 in Combination With Carboplatin + Etoposide + Atezolizumab in Subjects With Somatostatin Receptor Expressing (SSTR+) Extensive Stage Small Cell Lung Cancer (ES-SCLC)

This study aims to determine the safety, preliminary antitumor activity, and pharmacokinetics (PK) of RYZ101 in combination with standard of care (SoC) therapy consisting of carboplatin + etoposide + atezolizumab in untreated subjects with somatostatin receptor expressing (SSTR+) ES-SCLC


Prognostic Value of Combined Approach Based on KEAP1/NFE2L2 Mutations and Pre-therapeutic FDG-PET/CT Radiomic Analysis in Advanced Non-small-cell Lung Cancer PDL1 ≥ 50% Treated With Pembrolizumab.

Pembrolizumab has been approved for first-line locally advanced or metastatic NSCLC with a tumor proportion score (TPS) ≥50% for PDL1, based on the results of KEYNOTE-024. However, even with a positive PDL1 status, only a fraction of patients respond to immunotherapy. In the KEYNOTE-024 study evaluating pembrolizumab versus chemotherapy in first-line advanced NSCLC with PDL1 TPS ≥50%, the response rate in the pembrolizumab arm alone was 45%. NFE2L2 is a transcription factor that directs the expression of free radical defense genes that may interfere with radiation-induced DNA damage. KEAP1 is an adaptor protein that targets NFE2L2 for ubiquitination and proteasomal destruction as part of normal homeostasis. These new biomarkers are of clinical interest, as KEAP1/NFE2L2 mutations predict radiation resistance in patients with localized NSCLC treated with radiotherapy but not surgery. Some data also suggest a role for the KEAP1/NFE2L2 axis in response to immunotherapy. Establishing a predictive model for the presence of the KEAP1/NFE2L2 mutation would provide a tool for predicting survival (progression-free and overall), even before the patient starts immunotherapy.


18-FDG Tumour Metabolism Changes in PDL1 Superior to 50% Stage III/IV Non Small Cell Lung Cancer During First Line Treatment With Pembrolizumab

The aim of this study is to describe the early dynamics of 18-FDG uptake in non smal cell lung cancer during first line treatment with pembrolizumab, and to evaluate whether or not they differ according to treatment response at 3 months.



GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2

Patients will be treated with GD2-SADA and 177Lu-DOTA to study the safety and how well participants tolerate the treatment.



68Ga-NOTA-PEG2-RM26 PET/CT: Tracer Biodistribution and Uptake in Different Kinds of Cancer With Gastrin-Releasing Peptide Receptor (GRPR) Overexpression

The gastrin-releasing peptide receptor (GRPR), also known as bombesin receptor subtype II (BB2), is a member of the G protein-coupled receptor family of bombesin receptors. GRPR is over-expressed in various types of human tumors. RM26, a GRPR antagonist with high affinity, was discovered by peptide backbone modification of bombesin analogues. To target gastrin-releasing peptide receptor in human neoplastic cells NOTA-PEG2-RM26 was synthesised and then labeled with 68Ga. An open-label whole-body PET/ CT study was designed to investigate the safety and dosimetry of 68Ga-NOTA-PEG2-RM26 and to assess its clinical diagnostic value in patients with cancer.


Study of the Effects of Dexamethasone on Non-Small Cell Lung Cancer Using [F-18] FLT for Imaging With Positron Emission Tomography (PET)

This pilot research trial studies the effects of dexamethasone in patients with non-small cell lung cancer that has not responded after previous treatment. Drugs such as dexamethasone can affect how tumors grow and respond to treatments. Imaging tests, such as fluoro-L-thymidine (FLT) positron emission tomography , use a small amount of radioactive substance to show changes in tumor cells. Studying the effects of dexamethasone on lung tumors using FLT positron emission tomography may help doctors plan better treatments.


Application of 68Ga-labeled ACE2 Targeting Probe PET/CT Imaging in Tracing ACE2 Expression and Diagnosis of Lung Cancer

In the past three years, as the key protein suggested to be involved in host cell entry of SARS-CoV-2, studies of ACE2 aroused people's attention again. Tracking the expression of ACE2 in vivo is crucial to further understanding of COVID-19, dynamically monitoring the effect of antiviral therapy and the development of related vaccines. It is also expected to further conduct in-depth research on the physiological effects of ACE2 and RAAS, and the mechanism of ACEI/ARB (32). With the development of both molecular imaging agents and related equipment, several ACE2-targeting PET imaging agents have been investigated based on different strategies while some of them were tested in clinical trials. The aim of this study was to intercept key ACE2-binding sites from coronavirus RBD and test their potential as ACE2-targeting PET agents.


[68Ga]Ga-NOTA-RW102 PET Imaging in the Diagnosis of PD-L1-expressing Lung Cancer

The aim of this study was to establish and optimize the imaging method of [68Ga]Ga-NOTA-RW102, as well as its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agent was evaluated in patients with non-small cell lung cancer


First in Human Safety of [68Ga]-NOTA-hGZP- PET Imaging in Subjects Receiving Checkpoint Inhibitor Immunotherapy

First in Human Safety of [68Ga]-NOTA-hGZP PET Imaging in subjects with cancer undergoing treatment with a checkpoint inhibitor either as a monotherapy of in combination I-O therapy


Immuno-PET Imaging of Neuroendocrine Tumors Using 89Zr-DFO-SC16.56, a DLL3-targeting Monoclonal Antibody

The purpose of this study is to look at how safe 89Zr-DFO-SC16.56 is, and how it is processed by the body in people with small cell lung cancer.


Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography for Staging, Response Assessment, and Patient Selection in Metastatic Non-Small Cell Lung Cancer

This study investigates fluorine-18-AlphaVBeta6-BP ([18F]-αvβ6-BP) as a Positron Emission (PET) imaging agent in Non-Small Cell Lung Cancer (NSCLC) patients with brain metastases. Investigators hypothesize that [18F]-αvβ6-BP PET/Computed Tomography (CT) is a sensitive tool for disease assessment in patients with metastatic NSCLC, including those with brain metastases.


18F-FSPG PET/CT and Integrated Biomarkers for Early Lung Cancer Detection in Patients With Indeterminate Pulmonary Nodules

This phase II trial studies how well 18F-FSPG positron emission tomography (PET)/computed tomography (CT) work in diagnosing early lung cancer in patients with lung nodules. PET imaging with an imaging agent called 18F-FDG is often used in combination with a PET/CT scanner to evaluate cancers. Giving 18F-FSPG before a PET/CT scan may work better in helping researchers diagnose early lung cancer in patients with lung nodules.


Randomized Phase II Trial of Lutetium Lu 177 Dotatate Versus Everolimus in Somatostatin Receptor Positive Bronchial Neuroendocrine Tumors

This phase II trial studies the effect of lutetium Lu 177 dotatate compared to the usual treatment (everolimus) in treating patients with somatostatin receptor positive bronchial neuroendocrine tumors that have spread to other places in the body (advanced). Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. Lutetium Lu 177 dotatate may be more effective than everolimus in shrinking or stabilizing advanced bronchial neuroendocrine tumors.


A Clinical Imaging Study Using [18F]F-AraG PET to Visualize Tumor Infiltrating T-cell Activation in Non-small Cell Lung Cancer.

[18F]F-AraG is a promising tracer to image activated T-cells with positron emission tomography (PET). The aim of the ATTAIN trial is to investigate the pharmacokinetic characteristics of this novel tracer by performing a full kinetic modelling, assess test-retest (TRT) variability and to correlate the tumor tracer uptake with the pathological assessment.


Imaging of T-cell Activation With [18F]F-AraG in Advanced Non Small Cell Lung Cancer

This is a pilot study using [18F]F AraG PET imaging to evaluate the immunological response to checkpoint inhibitor therapy (CkIT) in patients with advanced NSCLC tumors at multiple study sites. The main objectives of the study are to quantify the change in [18F]F AraG PET signal before and after CkIT therapy, and to correlate this change in [18F]F AraG PET signal with a radiographic response.


A Pilot Study of 68Ga-FAPI-RGD PET/CT Imaging in the Lung Cancer Patients

Based on the high expression of specific receptors on the surface of diseased tissues and neovascularization, noninvasive targeted molecular imaging can be used to visualize lesions in vitro by combining specific ligands labeled with short half-life isotopes. Lung cancer tissues express fibroblast activating protein FAP, and also have high expression of integrin αVβ3 receptor on the surface of blood vessels. In this study, a novel dual-target imaging agent 68Ga-FAPI-RGD was used for PET/CT imaging of lung cancer.


68Ga-FAPI PET in Evaluation of the Patient With Known or Suspected Lung Cancer: Comparison With Standard 18F-FDG PET

This is a prospective, single-center, single arm, open label study to evaluate the performance of 68Ga-FAPI-46 for the diagnosis of primary and metastatic lesions of lung cancer with comparison to 18F-FDG PET.


A Clinical Imaging Study of the Changes in [18F]F-AraG Uptake Following Anti-PD-1 Therapy in Non-small Cell Lung Cancer

[18F]F-AraG is a promising tracer to image activated T-cells with positron emission tomography (PET). The aim of the SHARP trial is to investigate changes in [18F]F-AraG uptake following Anti-PD-1 therapy in patients with non-small cell lung cancer (NSCLC).


Evaluation of 89Zr-DFO-nimotuzumab for Non-invasive Imaging of EGFR Positive Cancers by Positron Emission Tomography (PET)

Over-expression of Epidermal Growth Factor Receptor (EGFR) on cells occurs in all aggressive cancers of epithelial origin. Existing tests for monitoring EGFR expression are invasive and not reliable. There needs to be a better way to measure EGFR expression in cancerous tumors to better tailor cancer treatments. This clinical trial aims to demonstrate the feasibility of imaging cancers that express EGFR using 89Zr-DFO-nimotuzumab and Positron Emission Tomography (PET)/Computerized Tomography (CT). By non-invasively imaging the status of EGFR, 89Zr-DFO-nimotuzumab could be used to assist in the identification of patients who are likely to respond to anti-EGFR treatments, including nimotuzumab. The hypothesis is that 89Zr-DFO-nimotuzumab will accumulate to tumors over-expressing EGFR making them visible when imaged with PET/CT. This hypothesis will be tested in this study, along with the optimal imaging time and diagnostic ability.


A Feasibility Study of Hypoxia Imaging in Patients With Lung Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)

The purpose of this study is to look for low levels of oxygen (hypoxia) in lung cancer using a positron emission tomography (PET) scan. Hypoxia can influence how lung cancer grows and responds to treatments like radiotherapy and chemotherapy. The use of PET scans to measure hypoxia may be better and simpler than the approaches used previously. This study will assess whether or not PET scans can provide useful information about hypoxia in lung cancer. In this study, a radiotracer called Fluoroazomycin Arabinoside (FAZA) will be used to measure hypoxia in the patient's tumour. FAZA has already been used in many cancers including lung cancer. Patients who consent to participate in this trial will receive 1 FAZA PET Scan prior to their first radiotherapy treatment


68Ga-grazytracer PET/CT of Tumor Responses to Immunotherapy in Subjects With Non-small Cell Lung Cancer or Melanoma

This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the clinical predictive value of 68Ga-grazytracer in subjects with non-small cell lung cancer or melanoma receiving immune checkpoint inhibitors (e.g., Ipilimumab, Nivolumab). A single dose of 2.96 MBq/kg body weight of 68Ga-grazytracer will be injected intravenously. The visual and semiquantitative methods will be used to assess the PET/CT images.


Radiogenomics in Aerodigestive Tract Cancers

Aerodigestive tract cancers are common malignancies. These cancers were ranked to be top-ten cancer-related deaths in Taiwan. Although many new target therapies and immunotherapies have emerged, many of the treatment eventually fail. For example, a 30-40% failure rate has been reported for target therapy, and, even higher for immune checkpoint inhibitors. A reliable model to more accurately predict treatment response and survival is warranted. The radiomic features extracted from F-18 fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) can be used to figure tumor biology such as metabolome and heterogeneity. It can therefore be used to predict treatment response and individual survival. On the other hand, genomic data derived from next-generation sequencing (NGS) can interrogate the genetic alteration of cancer cells. It can be used to feature genetic identification of the tumor and can also be used to identify target genes. However, both modalities have their weakness; a combination of the two may devise a more powerful predictive model for more precise clinical decision. The investigators plan to recruit patients aged at least 20-year with the diagnosis of aerodigestive tract cancers for radiogenomic study. Our previous studies have found that radiomic features derived from 18F-FDG PET can predict treatment response and survival in patients with esophageal cancer treated with tri-modality method. The investigators also discovered that radiomics could predict survival in patients with EGFR-mutated lung adenocarcinoma treated with target therapy. In addition, our study results showed that the level of PD-L1 expression is associated with radiomics as well. The investigators plan to add genomic data into radiomics and interrogate cancers from different aspects. The investigators seek to devise a more precise model to predict the treatment response and survival in patients with aerodigestive tract cancers.


PET Imaging With [18F]F-AraG in Advanced Non-small Cell Lung Cancer (NSCLC)

This is a prospective, single center, single-arm clinical trial in 20 patients with non-small cell lung cancer (NSCLC) undergoing PD-1/PD-L1-directed therapy. This research is being done to find out if the radioactive compound called [18F]F-AraG is a helpful imaging agent for detecting changes in cancer's anti-tumor immune response (or activation of T-cell) levels for non-small cell lung cancer (NSCLC) patients who will receive a cancer immunotherapy regimen (immunotherapy works by encouraging the body's own immune system to attack the cancer cells).