A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer

Study Overview
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Brief Summary
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The purpose of this study is to see whether 68Gallium PSMA-PET/CT scans are an effective way to detect sites of cancer in people with metastatic bladder cancer. The study researchers want to learn if a 68Gallium PSMA PET/CT scan will work better, the same, or not as well as the PET/CT scans doctors usually use for imaging bladder cancer (FDG-PET/CT scan).

Official Title
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Pilot Study of 68Gallium PSMA-PET/CT in Patients With Metastatic Urothelial Carcinoma

Conditions
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Bladder Cancer

Intervention / Treatment
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* Drug: [68Ga]PSMA
* Diagnostic Test: PET/CT imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically confirmed metastatic urothelial carcinoma with extrapelvic nodal and/or visceral sites of disease (including lung, liver, bone, or soft tissue) At least 3 lesions assessable by FDG PET/CT according to RECIST and PERCIST guidelines where applicable, that are determined suspicious for metastasis by an MSKCC attending radiologist or nuclear medicine physician. Karnofsky performance status ≥50% (or ECOG/WHO ≤2) Participant is ≥18 years of age Patient must be able to understand and is willing to sign a written informed consent document Exclusion Criteria: Patients with pelvic node-only metastatic disease. If the patient has lymph node only disease, at least one PET-assessable node must be located outside of the pelvis Patients with bone only disease Unable to lie flat, still, or to tolerate a PET scan Patient undergoing active treatment for non-urothelial malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized. Patients on a therapeutic clinical trial Patients undergoing active surveillance with a known history of non-urothelial malignancies Women who are pregnant. All women of childbearing potential must have a documented negative pregnancy test.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: This is a prospective, single-arm pilot study of 68Gallium PSMA-PET/CT imaging in patients with metastatic urothelial carcinoma.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Gallium PSMA-PET/CT<br>Patients will initially undergo a standard of care FDG PET with diagnostic CT scan followed by an investigational 68Ga PSMA PET/CT scan. | Drug: [68Ga]PSMA<br>* 68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.<br>Diagnostic Test: PET/CT imaging<br>* 68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT | If 6 of 10 patients have at least one lesion identified both on standard of care FDG PET/CT and also detected on 68Gallium PSMA-PET/CT, this imaging modality will be worthy of further exploration in metastatic UC. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic, Urothelial carcinoma, 68Gallium, PSMA-PET/CT, 22-157