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NCT05977322

Treatment & Imaging Locally Advanced Cancer

The purpose of the study is to test the safety and dosing of [177Lu]Lu-FF58, a radioligand therapy for patients with advanced or metastatic tumors that express proteins known as integrins: alpha-v beta-3 integrin (αvβ3) and alpha-v beta-5 integrin (αvβ5). The study will also further characterize the radioligand imaging agent [68Ga]Ga-FF58 including its ability to identify tumor lesions and its safety profile.

NCT04712721

Imaging Undefined Stage

Ga68 FF58 PET Scan in Solid Tumors (Pancreas, Esophageal, Brain) αvβ3 and αvβ5 (+)

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NCT05799274

Imaging Undefined Stage

The objective of this clinical trial is to determine the safety of an intravenously administered radioisotope, RAD301 ([68Ga]-Trivehexin), in either healthy volunteers or patients with pancreatic cancer. All subjects will undergo: Screening, which entails physical examination and blood samples for standard blood testing. Subjects that successfully pass screening will undergo: Gallium-68 PET scanning procedures, which will occur during a single day (about 5-6 hours). These subjects will return to the clinic at 2 weeks for additional safety labs. All scanned subjects will also be evaluated by telephone follow up on a weekly basis for 1 month after scanning.

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NCT05605522

Treatment Metastatic Cancer

Ac225 FPI-2059 in Adult Patients with various Solid Tumors: Pancreatic, Colon, etc.

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NCT06147037

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).

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NCT05432193

Treatment Undefined Stage

Dosimetry trial of Lu177-PNT6555 in selected Solid Tumors


NCT05568017

Neoadjuvant Peptide Receptor Radionuclide Therapy (PRRT) With 90Y-DOTATOC in Pancreatic Neuroendocrine Tumours.

Neuroendocrine tumors (NETs) are relatively rare tumors, mainly originating from the digestive system, that tend to be slow growing and are often diagnosed when metastatic. Surgery is the sole curative option, but is feasible only in a minority of patients. Peptide Receptor Radionuclide Therapy (PRRT) has been experimented for almost 20 years and is an established effective therapeutic modality for well/moderately differentiated, inoperable or metastasized gastro-entero-pancreatic (GEP) and bronchial NETs. Clinical studies demonstrated that partial and complete objective responses can be obtained in up to 30% of patients. Side effects may involve the kidneys and the bone marrow and are usually mild. Renal protection is used to minimize the risk of a late decrease of renal function.

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NCT05141643

18F-FAC PET Imaging to Quantify Gemcitabine Tumor Drug Uptake and Biodistribution in Pancreatic Cancer Patients

The purpose of this study is to find out whether a pre-treatment PET scan using the experimental imaging tracer 18F-FAC can show how much of the standard chemotherapy for PDAC may be taken up by the cancer.

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NCT05262855

A Phase 2, Multicenter, Single Arm, Open Label Non-Randomized Study of [68Ga]FAPI-46 PET in Patients With Resectable or Borderline Resectable Pancreatic Ductal Carcinoma

This is a prospective, multi-center, single arm, open label, non-randomized study to evaluate the ability of [68Ga]FAPI-46 to detect FAP expressing cells in patients with resectable or borderline resectable PDAC. The [68Ga]FAPI-46 PET scans will be acquired after initial staging using institutional standard methods. If the participant is prescribed neoadjuvant therapy, a second [68Ga]FAPI-46 PET scan will be performed within 21 days prior to planned surgical resection. This will be followed by histopathology and IHC analyses and comparison to resected PDAC tumor specimens.

NCT05275985

A Prospective Pilot Study to Explore Performance and Efficacy of 68Ga-FAPI PET/CT in Pancreatic Ductal Carcinoma Patients

Fibroblast activation protein (FAP) is overexpressed in cancer-associated fibroblasts (CAFs), which constitutes a major proportion of cells within the tumor microenvironment, especially in primary pancreatic ductal carcinoma (PDAC). In this prospective study, we aimed to evaluate the performance and value of 68Ga-FAPI-04 PET/CT in the patients with PDAC.

NCT06129422

A Phase I Trial to Assess Safety, Tolerability, Pharmacokinetics, Radiation Dosimetry, and Positron Emission Tomography (PET) Imaging Properties of 89Zr-labeled hNd2 (NMK89) in Patients With Pancreatic Cancer Histologically Positive for MUC5AC

This trial will be a non-randomized, Phase I trial to evaluate safety, tolerability, biodistribution, radiation dosimetry, pharmacokinetics and PET imaging properties following an infusion of 37 MBq (1 mCi) of 89Zr-labeled hNd2* (NMK89) in patients with pancreatic cancer that are positive for MUC5AC. Image acquisition is conducted using a PET/CT machine. * hNd2: Recombinant humanized Nd2 (anti-human MUC5AC monoclonal antibody)

NCT05466799

An Open-label, Multi-centre, Randomized Study of TaRgeted Intratumoural Placement of P-32 (OncoSil™) in Addition to FOLFIRINOX Chemotherapy vs FOLFIRINOX Alone in Patients With Unresectable Locally Advanced Pancreatic Adenocarcinoma.

The purpose of the study is to assess the safety and efficacy of OncoSil™ when given in addition to standard FOLFIRINOX chemotherapy for treatment of Locally Advanced Pancreatic Cancer

NCT04395469

Feasibility Study of Hypoxia and Re-oxygenation Imaging in Pancreatic Cancer Using Positron Emission Tomography (PET) With [18F] Fluoroazomycin-arabinoside (FAZA PET) and Magnetic Resonance Imaging (MRI)

This is a single arm, single centre, investigator initiated study to investigate the use of FAZA-PET in combination with MRI. FAZA is an investigational radiotracer used in PET scans. FAZA PET-MRI will be used to measure hypoxia in up to 20 patients with unresectable, non-metastatic, locally advanced un-resectable pancreatic adenocarcinoma (LAPAC). After each FAZA PET-MRI scan, patients will be followed up via telephone, 48 hours after the imaging session to assure that the procedure was tolerated without side effects. Patients will undergo a FAZA PET-MRI scans before and after their standard of care radiation treatment.

NCT04485286

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.

NCT05247905

Phase II Randomized, Prospective Trial of Lutetium Lu 177 Dotatate PRRT Versus Capecitabine and Temozolomide in Well-Differentiated Pancreatic Neuroendocrine Tumors

This phase II trial compares capecitabine and temozolomide to lutetium Lu 177 dotatate for the treatment of pancreatic neuroendocrine tumors that have spread to other parts of the body (advanced) or are not able to be removed by surgery (unresectable). Chemotherapy drugs, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. The purpose of this study is to find out whether capecitabine and temozolomide or lutetium Lu 177 dotatate may kill more tumor cells in patients with advanced pancreatic neuroendocrine tumors.

NCT05131776

Concurrent EUS-guided Intra-tumour Injection of OncoSil (32P) With Chemotherapy in Locally Advanced Pancreatic Carcinoma.

The outcomes of concurrent EUS-guided intra-tumour injection of P-32 microparticles (OncoSil; OncoSil Medical, Australia) with chemotherapy in locally advanced pancreatic carcinoma in the local population is uncertain. The aim of the current study is to assess efficacy and safety of the intervention in the local population. We hypothesis that the intervention is safe and useful for tumour downstaging.

NCT05172310

PET Imaging of Tumors in Pancreas, Bile Ducts, Stomach and Ovaries by a Novel Tracer, 68Ga-FAPI-46 = Fibroblast Activation Protein Inhibitor

Cancers of the pancreas, bile ducts, stomach and ovaries are dismal diseases with most patients being diagnosed in advanced stages leading to a bad prognosis. These cancers can be difficult to diagnose and sometimes impossible to differentiate from underlying benign conditions. Establishing the correct diagnosis of primary cancer lesions and possible spread to other organs in time is pivotal for choosing the right therapy. Routinely applied staging procedures are however not always reliable. The main aim in this study is to evaluate the diagnostic accuracy of PET/CT with a novel radiotracer, FAPI, in the primary diagnosis of cancers in the pancreas, stomach and bile ducts as well as in patients with primary and recurrent epithelial ovarian cancer (EOC).

NCT05518903

Quantitative In Vivo 68Ga-Fibroblast-Activation-Protein-Inhibitors (FAPI)-46 PET Imaging of Cancer-Associated Fibroblasts (CAFs) in Pancreatic Ductal Adenocarcinoma (PDA)

This phase II trial tests whether 68Ga-FAPI-46 positron emission tomography (PET)/computed tomography (CT) scan works to image cancer-associated fibroblasts (CAFs) in patients with pancreatic ductal adenocarcinoma (PDA) that has not spread to other parts of the body (localized). CAFs are a type of connective tissue cell that are found within or near cancerous tissue. Many CAFs express a protein called fibroblast activation protein (FAP) that are not found on healthy cells in large amounts. 68Ga-FAPI-46 is a radioactive chemical compound designed to circulate through the body and attach itself to FAP on PDA cells. A PET/CT scan is then used to detect the location of FAP lesions. PET scan is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Because cancer cells often take up more glucose than normal cells, the pictures can be used to find cancer cells in the body. CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional (3-D) views of tissues and organs. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination. Giving 68Ga-FAPI-46 PET/CT may help doctors improve upon the diagnosis and management of PDA.

NCT05641896

A Phase 2, Multicenter, Single Arm, Open Label, Non-Randomized Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers

Prospective, multi-center, open label, non-randomized clinical trial to assess efficacy of [18F]FAPI-74 to detect FAP expressing cells in patients diagnosed with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer. The [18F]FAPI-74 PET scan will be acquired in patients with proven GI cancers after initial staging using institutional standard methods. The PET scan results will be compared to FAP immunohistochemistry (as the primary objective) and histopathology (as the secondary objective) of the biopsied or resected tissues.

NCT05737615

A Phase I Study of Pretargeted PET Imaging Using 64Cu-Tz-SarAr and a Trans-Cyclooctene-Modified Humanized 5B1 Immunoconjugate (hu5B1-TCO) in Patients With CA19-9-Positive Pancreatic Cancer

The purpose of this study is to find the highest safe dose of hu5B1-TCO and the best dosing schedule of hu5B1-TCO and 64Cu-Tz-SarAr for finding cancer cells that are CA19-9 positive. This study will also help to find out how much radiation the body is exposed to when 64Cu-Tz-SarAr is used, and provide information on the way the body absorbs, distributes, and gets rid of 64Cu-Tz-SarAr.

NCT05875753

Preliminary Study of 68Ga-FAPI-FS PET/CT in Patients With Pancreatic Cancer

This is a preliminary phase 0 study in patients with confirmed or suspicious pancreatic cancer. Each patient will receive one dose of 68Ga-FAPI-FS by intravenous route. Dedicated whole-body PET/CT imaging will be performed. A comparative 18F-FDG PET/CT will also be performed within a week.

NCT05784597

A Phase I Study to Evaluate the Safety and Dosimetry of 68Ga-labelled OncoFAP Derivatives in Patients With Solid Tumors

Phase I, multicenter study in patients with a confirmed diagnosis of solid tumor among breast cancer, colorectal cancer, oesophageal cancer and pancreatic adenocarcinoma, requiring clinical staging for nodal staging and/or metastatic disease (based on institutional practice and risk stratification). All patients will receive a single intravenous bolus administration of 250 MBq (225 - 275 MBq). [68Ga]Ga-OncoFAP biodistribution, PK, and dosimetry of [68Ga]Ga-OncoFAP will be assessed based on a series of PET/CT scans, blood and urine sampling.

NCT05706129

A Multicenter, Open-Label, Non-Randomized Phase 1/2 Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Patients With Unresectable Locally Advanced or Metastatic Solid Tumors

The main purpose of Part A of the study is to evaluate safety, tolerability and tracer uptake after a single intravenous (IV) administration of [68Ga]Ga-DPI-4452; Part B: is to determine the recommended phase 2 dose (RP2D) [maximum tolerated dose (MTD) or lower dose] for [177Lu]Lu-DPI-4452 for each tumor type; Part C: is to evaluate the preliminary antitumor activity of [177Lu]Lu-DPI-4452 as monotherapy.

NCT05687123

A Phase I Dose Escalation-Expansion Trial of Sunitinib Malate Plus Lutetium Lu 177 Dotatate (Lutathera) in Somatostatin Receptor Positive Pancreatic Neuroendocrine Tumors

This phase I trial tests the safety, side effects, and best dose of sunitinib malate in combination with lutetium Lu 177 dotatate in treating patients with pancreatic neuroendocrine tumors. Sunitinib malate is in a class of medications called kinase inhibitors and a form of targeted therapy that blocks the action of abnormal proteins called VEGFRs that signal tumor cells to multiply. This helps stop or slow the spread of tumor cells. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and not harm normal cells. It is also a form of targeted therapy because it works by attaching itself to specific molecules (receptors) on the surface of tumor cells, known as somatostatin receptors, so that radiation can be delivered directly to the tumor cells and kill them. Giving sunitinib malate and lutetium Lu 177 dotatate in combination may be safer and more effective in treating pancreatic neuroendocrine tumors than giving either drug alone.

NCT04665947

First-in-human Study of the Theranostic Pair [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G in Pancreatic Cancer

This is a Phase I, first-in-human study to evaluate the safety and efficacy of the [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G theranostic pair in patients with locally advanced or metastatic pancreatic adenocarcinoma (PDAC).

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NCT04883775

89Zr-DFO-HuMab-5B1 (MVT-2163) Imaging in Pancreatic Cancer or Other CA19-9 Positive Malignancies

The purpose of this study is to see how well the experimental imaging agent 89Zr-DFO-HuMab-5B1 attaches to pancreatic tumors, and to find out whether PET/CT scans done with this imaging agent produce better images of cancer.