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NCT04071223

A Phase II Randomized Trial of Radium-223 Dichloride and Cabozantinib in Patients With Advanced Renal Cell Carcinoma With Bone Metastasis (RadiCal)

This phase II trial studies whether adding radium-223 dichloride to the usual treatment, cabozantinib, improves outcomes in patients with renal cell cancer that has spread to the bone. Radioactive drugs such as radium-223 dichloride may directly target radiation to cancer cells and minimize harm to normal cells. Cabozantinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving radium-223 dichloride and cabozantinib may help lessen the pain and symptoms from renal cell cancer that has spread to the bone, compared to cabozantinib alone.

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NCT06428708

Comparison of [18F] PSMA-1007 PET/CT and Conventional Imaging in the Detection of Metastatic Clear Cell Renal Cell Carcinoma

Staging of kidney cancer is primarily achieved by computerized tomography (CT) scans or magnetic resonance imaging (MRI). If a patient is found to have limited metastatic disease, surgical removal or radiation therapy could be considered in order to control the majority of the disease. However, if metastases are more widespread, systemic (drug) therapy may be the preferred management option. The identification of additional metastatic sites using more sensitive imaging modalities therefore has the potential to alter management, and this remains an unmet need in the field. This study will investigate the utility of positron emission tomography (PET) imaging with PSMA (prostate specific membrane antigen). Kidney cancer of the clear cell subtype has demonstrated high expression of PSMA, making it a disease in which PSMA-targeted PET imaging could help to identify occult metastatic disease.

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NCT06389682

Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of a Single Dose of Gallium [68Ga]-NYM005 Injection Prepared by Kit for the Preparation of the 68Ga-NYM005 Injection in Patients With Metastatic Clear Cell Renal Carcinoma.

68Ga-NYM005 is a CAIX-targeting small-molecular radiotracer for PET/CT imaging of clear cell renal cell carcinoma

NCT06182644

Head-to-head Comparison of Positron Nuclide Radio-labeled FAPI and 18F-FDG PET/CT in Patients With Malignant Tumors

The latest research has found that the use of positron-labeled FAP inhibitors for targeting FAP has achieved very good results in displaying tumor stroma, especially for tumors with poor FDG PET/CT observation, such as liver cancer, renal cancer, and gastric cancer. Although the studies were based on small sample data or case reports, they achieved significantly better results than 18F-FDG [13,15-17].

NCT05744128

Positron Emission Tomography Repeatability Evaluation of Tissue Zirconium 89Zr Crefmirlimab Berdoxam

Zr-89 crefmirlimab berdoxam is a Zirconium-89 labelled minibody developed by ImaginAb for full body PET imaging of CD8+ cell distribution (CD8 ImmunoPET). The primary objective of this study is to assess the test-retest repeatability of CD8 immunoPET imaging in oncology patients with stable disease.

NCT05879497

68Ga-NY104 PET/CT in Patients With Metastasis/Recurrence Clear Cell Renal Cell Carcinoma Suspicion: a Prospective, Single Center, Single Arm Imaging Trial

This is a prospective, single-center, single-arm phase 2 study in patients with clear cell renal cell carcinoma and metastasis or recurrence suspicion. The goal is to determine the sensitivity and specificity of 68Ga-NY104 PET/CT in patients with clear cell renal cell carcinoma and metastasis or recurrence suspicion

NCT05879510

68Ga-NY104 PET/CT for the Detection of Clear Cell Renal Cell Carcinoma in Presurgical Patients With Renal Masses

This is a prospective, single-center, single-arm, diagnostic phase 2 study in patients who have renal masses scheduled for surgical resection. The goal is to determine the sensitivity and specificity of 68Ga-NY104 PET/CT in the detection of clear cell renal cell carcinoma using histopathological diagnosis as ground truth, in patients with operable renal masses.

NCT05902377

68Ga-NY104 PET/CT Imaging in Patients With Confirmed or Suspicious Renal Cell Carcinoma

This is a prospective, single-center study in patients with renal cell carcinoma. The goal is to determine the sensitivity and specificity of 68Ga-NY104 PET/CT in the detection of clear cell renal cell carcinoma.

NCT05170555

Diagnosis of Renal Cell Carcinoma on 68Ga-PSMA PET-CT and Radioligand Therapy With 177Lu-EB-PSMA-617

Renal Cell Carcinoma (RCC) is the second most common tumor in urology. Considering its origination from kidney, an organ with intense physiological uptake and excretion of 68Ga-PSMA, this study aims to evaluate the uptake of 68Ga-PSMA in RCC compared to 18F-FDG in the same patients, and assess the feasibility of 177Lu-EB-PSMA-617 treatment in patients with the advanced RCC.

NCT05879471

68Ga-NY104 PET/CT and 18F-FDG PET/CT in Patients With Metastatic Clear Cell Renal Cell Carcinoma: a Prospective, Single Center, Single Arm, Comparative Imaging Trial

This is a prospective, single-center, single-arm, comparative phase 2 study in patients with metastatic clear cell renal cell carcinoma. The goal is to determine the sensitivity of 68Ga-NY104 PET/CT in patients with metastatic clear cell renal cell carcinoma and compare it with 18F-FDG PET/CT.

NCT04802824

Determining the Magnitude of Change in [18F]FPIA-detectable Short Chain Fatty Acid Uptake in Metastatic Renal Cell Cancer Following Therapy

Renal cell carcinoma (RCC) is the most prevalent and lethal malignancy of the kidney. At the time of diagnosis, as many as a fifth of patients have metastatic disease (mRCC). Despite advances in treatment, long-term survival rates remain poor. 18F-fluoropivalate ([18F]FPIA) is a new tracer that images short chain fatty acid (SCFA) uptake in tumours, a key component of fatty acid oxidation. The aim of the study is to investigate longitudinal changes in [18F]FPIA uptake at baseline, at 4-6 weeks and at 12 weeks following treatment initiation in patients using tyrosine kinase inhibitors (TKI's), chemotherapy, immunotherapy, or combinations of these. The investigators hypothesise that the import of [18F]FPIA-detectable SCFA into tumours is high and decreases with effective treatment.

NCT04987086

A Single Center Prospective Study of Diagnostic Efficiency of 68Ga-PSMA PET in the Patients With Locally Advanced and Advanced Renal Cell Carcinoma

The primary research purpose is to evaluate the diagnostic efficacy of 68Ga-PSMA PET in metastatic lesions of locally advanced and advanced renal cell carcinoma, and to compare with that of enhanced CT. The second purpose is to evaluate whether 68Ga-PSMA PET can change the treatment decision of patients with locally advanced and advanced renal cell carcinoma

NCT05888532

A First-in-Human, Phase I/II PET Imaging Study of 64Cu-GRIP B, a Radiotracer Targeting Granzyme B, in Patients With Advanced Genitourinary Malignancies

This is a first-in-human phase I/II imaging study of 64Cu-GRIP B PET in patients with advanced genitourinary (GU) malignancies. The tracer is designed to detect extracellular granzyme B as it is secreted by activated immune cells in the tumor microenvironment, which may highlight tumors that will regress on treatment with immunomodulatory therapies. The study population is focused on genitourinary malignancies, including renal cell and urothelial cancer, two tumor types with high mutational burden and tumor infiltrating lymphocytes compared to other tumor types, and have a predictable response rate at the population level to immune checkpoint inhibitors.

NCT05868174

A Phase 1b Dose Escalation/Expansion Study of the Combination of 177Lu-TLX250 and Peposertib in Patients With Carbonic Anhydrase IX (CAIX)-Expressing Solid Tumors

This is an open label, single-arm, multicentre dose escalation (Part 1) and dose expansion (Part 2) study to evaluate different combinations of 3 radioactive dose levels of 177Lu-TLX250 administered intravenously with 3 different doses of peposertib in patients with CAIX-expressing solid tumors.

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.

NCT05638256

68Ga-labeled NY104 PET Imaging in Patients

This is a single arm study to evaluate the safety and biodistribution of 68Ga-labeled NY104 PET Imaging in patients with Renal Cell Carcinoma

NCT04989959

An Exploratory Study of [18F]PT2385 PET/CT in Patients With Renal Cell Carcinoma

This is an exploratory study to assess [18F]PT2385 Positron Emission Tomography/Computed Tomography (PET/CT) in patients with renal cell carcinoma (RCC). This is an open-label, nontherapeutic trial. The main objective is to correlate hypoxia-inducible factor-2alpha (HIF2α) levels as determined by an investigational [18F]PT2385 PET/CT scan with the levels on subsequently obtained tissue by HIF2α immunohistochemistry (IHC). There will be two cohorts. The first pre-surgical cohort will have [18F]PT2385 PET/CT prior to nephrectomy. The uptake and retention on Positron Emission Tomography (PET), quantified as standardized uptake value (SUV) max and mean, abbreviated SUV henceforth will be correlated with HIF2α levels by IHC on the primary tumor. The second cohort will comprise patients with metastatic clear cell renal carcinoma (ccRCC). SUV will be correlated with HIF2α levels measured by IHC on a biopsy sample from a metastasis. Both low- and high-avidity sites will be biopsied and tracer uptake correlated with HIF2α IHC.

NCT04006522

An Exploratory Study of 89Zr-DFO-Atezolizumab ImmunoPET/CT in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma

This is an exploratory clinical trial to assess the potential of 89Zr-DFO-Atezolizumab Positron Emission Tomography/Computed Tomography (PET/CT) scans in patients with locally advanced or metastatic renal cell carcinoma (RCC). This open label, nontherapeutic trial will test the correlation of 89Zr-DFO-Atezolizumab immunoPET/CT with programmed death-ligand 1 (PD-L1) expression and the response to immune checkpoint inhibitor therapy in patients with RCC. There will be two cohorts, one made up of patients with localized RCC who will undergo 89Zr-DFO-Atezolizumab PET/CT prior to nephrectomy and a second cohort of patients with metastatic RCC who will undergo 89Zr-DFO-Atezolizumab PET/CT prior to treatment with an immune checkpoint inhibitor.

NCT05239533

A Phase 2 Open-label Study of Nivolumab Combined With Lutetium 177-Labeled Anti-Carbonic Anhydrase IX Monoclonal Antibody Girentuximab in Patients With Clear Cell Advanced Renal Cell Carcinoma

The purpose of this study is to see if the combination of 177Lu-girentuximab and nivolumab is a safe and effective treatment for advanced clear cell renal cell carcinoma/ccRCC that has the CAIX protein.

NCT06148220

A Study of the Clinical Application of [18F]RCCB6 PET Imaging in the Diagnosis of CD70-expressing Multiple Tumors

The aim of this study was to establish and optimize the [18F]RCCB6 imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in renal cancer and lymphoma was evaluated.

NCT05861778

An Open-label, Phase I Study to Evaluate the Safety, Radiation Dosimetry and Pharmacokinetics of 89Zr-TLX250 PET/CT in Patients With Indeterminate Renal Masses or Suspected Recurrent Renal Clear Cell Carcinoma

The study is designed to evaluate the safety, tolerability, radiation dosimetry and pharmacokinetics 89Zr-TLX250 (also known as 89Zr-DFO-girentuximab) Positron Emission Tomography/Computed Tomography (PET/CT) in adult Chinese patients with indeterminate renal masses or Suspected Recurrent Renal Clear Cell Carcinoma

NCT05663710

Phase 1b/2 Study of Combination 177Lu Girentuximab Plus Cabozantinib and Nivolumab in Treatment naïve Patients With Advanced Clear Cell RCC

To learn if giving 177Lu girentuximab in combination with cabozantinib plus nivolumab can help to control advanced clear cell renal cell carcinoma (ccRCC).