(10 results)
Bladder/Urothelial (GU)
Study Status
Last Updated: Tue Nov 04 2025
Jeremie Calais, MD, PhD, University of California Los Angeles, Nuclear Medicine Clinic Imaging Undefined Stage
This exploratory study investigates how an imaging technique called 68Ga-FAPi-46 PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with cancer. Because some cancers take up 68Ga-FAPi-46 it can be seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors (cancer associated fibroblasts). The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers.
NCT04724928
Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients With Muscle Invasive Bladder Cancer (EFFORT-MIBC): A Phase II Prospective Trial
Evaluate the impact of 18F-FDG-PET-CT on the staging of patients with muscle invasive bladder cancer. Based on the results of 2 18F-FDG-PET-CT's patients are stratified in non-metastatic, oligometastatic and polymetastatic bladder cancer patients and the treatment is adapted accordingly to improve overall survival.
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.
NCT06120413
Clinical Evaluation of 18F-LN1 PET/CT for Imaging of Nectin-4 in Urothelial Carcinomas
The clinical feasibility of 18F-LN1 PET/CT will be evaluated in 30 patients with urothelial carcinoma, and the results will be compared with those of 18F-FDG.
NCT06503146
18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection
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Fibroblast-activation protein (FAP) is an enzyme that appears in high numbers in certain cancer cells. [18F]FAPI-74 is a new tracer-a substance that is injected into a person s body before an imaging scan. Researchers believe that [18F]FAPI-74 may be able to highlight FAP enzymes more effectively than approved tracers. If so, the new tracer would make it easier to find FAP-positive tumors in the body.
NCT06645808
The Safety, Tolerability and Biodistribution of a Single Intravenous Administration of Two Zirconium-89 Labelled Vartumabs (F8scFV or C9scFv) in Patients with Solid Tumors - a Phase 0, Open Label, PET/CT Molecular Imaging Basket Trial
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VARTUTRACE is a first-in-human PET/CT molecular imaging study in patients with solid tumors. This study will investigate the biodistribution and pharmacology of two antibody fragments binding oncofetal Chondroitin Sulfate (CS). Oncofetal CS are tumor-specific carbohydrate motifs present in proteoglycans and identified by VAR2 Pharmaceuticals as expressed during fetal development. Oncofetal CS reappears in the vast majority of cancers while remaining largely absent from normal tissues. VAR2 Pharmaceuticals recently developed antibodies specific for oncofetal CS. VARTUTRACE uses two of these as radiolabeled antibody fragments to study biodistribution, tumor accumulation, pharmacodynamics and clearance pathways in a diverse patient population.
NCT06763354
An Exploratory Clinical Study of the Efficacy of Gallium[68Ga]NOTA-DNA Multivalent SGC8 Injection for Bladder Tumour Imaging
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The primary study was the ability of gallium [68Ga] NOTA-DNA multivalent SGC8 injection to provide tumor-specific imaging of bladder tumor patients of different genders, with a compliance rate of more than 80% when compared to the gold standard TUR pathology.
NCT06880757
177Lu-FAP-2286 Treatment in Urethelial Neoplasms: Utility and Safety as a Novel Treatment.
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Ga-68-FAPI has recently been proven to be superior to F-18-FDG in various cancers. These results have also raised hope in using FAP radiopharmaceuticals with theranostic approach. Lu-177 bound FAPI molecules have been started to be used in some cancers in clinical trials following its efficacy proven by case reports. Similarly,as a pilot study, this project aims to investigate safety and efficacy of Lu-177- FAP-2286 in metastatic urothelial carcinomas of bladder.
NCT07140315
An Open-label, Single-center Clinical Trial of [18F]DK222 PET/CT for Imaging of Patients With Non-Small-Cell Lung Cancer (NSCLC) and Urothelial Cancer Who Are Eligible for Treatment With Anti-PD(L)-1
This Phase 1 clinical trial will test a new drug called [18F]DK222 in people with cancer. The goal is to see if the drug is safe, how it spreads through the body, how long it stays in the body, and how much radiation it gives off. [18F]DK222 is designed to attach strongly and specifically to a protein called PD-L1, which helps cancer hide from the immune system.
NCT06005116
Exploratory Study on the Effectiveness of Gallium [68Ga] NOTA-SGC8 Injection in the Staging of Bladder Cancer
Brief Summary: The goal of this clinical trial is to test the imaging and diagnostic ability of [68Ga]-NOTA-SGC8 PET/MR in bladder cancer patients with different stages. The main questions it aims to answer are: Tumor specific lighting ability of [68Ga]-NOTA-SGC8 in bladder cancer patients with different stages. The safety of [68Ga]-NOTA-SGC8. Participants will be irrigated with [68Ga]-NOTA-SGC8 into the bladder for tumor imaging under PET/MR. The imaging performance of [68Ga]-NOTA-SGC8 on different stages of bladder tumors will be systematically evaluated by combining with pathological sections of patients. Urine accumulation and radioactivity distribution of [68Ga]-NOTA-SGC8 will be measured. The adverse events will be recorded.
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