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

{ "A Study of 68Gallium PSMA-PET/CT Scans for Bladder or Skin Cancer", "This study is looking at whether a special type of scan, called a 68Gallium PSMA-PET/CT, can effectively find cancer in people with metastatic bladder cancer or skin cancer. Researchers want to compare this new scan to the standard FDG-PET/CT scan usually used. You might be able to join if you have metastatic bladder cancer that has spread to other parts of your body, like your lungs, liver, or bones, and your cancer can be seen on a standard FDG-PET/CT scan. The study aims to see how many patients have at least one cancer site detected by the 68Gallium PSMA-PET/CT scan. The study plans to enroll 20 participants, but its current status is unclear.", "design": "This is an interventional study, meaning participants will receive a specific intervention (the 68Gallium PSMA-PET/CT scan). It plans to enroll 20 participants.", "commitments": "Participants will receive a 68Gallium PSMA-PET/CT imaging scan within 10 days after their standard FDG-PET/CT scan.", "compensation": "Not stated in the trial record.", "follow_up": "The study will measure outcomes for up to 1 year after the scan.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

PHASE1Ages 18+InterventionalDiagnostic

Memorial Sloan Kettering Cancer Center

~20 participants

Updated 2026-04-22 on ClinicalTrials.gov

What's tested:[68Ga]PSMAPET/CT imaging

At a glance

Recruiting sites

7 of 7 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT for Urothelial Carcinoma

Measured over 1 year

+1 more outcome measured

Conditions

Bladder Cancer

Where it's being run

7 sites across 2 states

New York4

New Jersey3

Study leadership

Gopakumar Iyer · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Gopakumar Iyer, MD

[email protected]

646-888-4737

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 1 lesion 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

Patients with histologically confirmed metastatic melanoma

At least 1 metastatic lesion assessable by CT or FDG PET/CT according to RECIST that is determined to be suspicious for metastasis by an MSKCC attending radiologist or nuclear medicine physician

ECOG \<= 2

Participant is \>= 18 years of age

Patient must be able to understand and is willing to sign a written informed consent document

Exclusion

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 where PSMA imaging would interfere with the conduct of the 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.

Unable to lie flat, still, or tolerate PET scan.

Patient is on another therapeutic trial where PSMA imaging would interfere with the conduct of the trial.

Women who are pregnant. All women of childbearing potential must have a documented negative pregnancy test.

What this trial measures

Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT for Urothelial Carcinoma1 year
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.
Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT for Melanoma1 year
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 Melanoma.

Trialytics