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

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Criteria

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.