NCT05562791RecruitingPhase 1
A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer or Skin Cancer
Pilot Study of 68Gallium PSMA-PET/CT in Patients With Metastatic Urothelial Carcinoma or Melanoma
Source: ClinicalTrials.gov · Last updated 22 Apr 2026
Brief summary (registry, in English)
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 or skin 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 or skin cancer (FDG-PET/CT scan).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 28 Sept 2022
- Start date
- 28 Sept 2022
- Primary completion date
- Sept 2027
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Bladder cancer, Melanoma
- NCT number
- NCT05562791
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 28 Sept 2022 to the primary completion date, Sept 2027
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Patient undergoing active treatment for non-urothelial malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized.
- Patients undergoing active surveillance with a known history of non-urothelial malignancies
Other
- Unable to lie flat, still, or to tolerate a PET scan
- Patients on a therapeutic clinical 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.
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Consent Only) Coordinator of this site? Confirm its status | Basking Ridge | United States | Recruiting |
| Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) Coordinator of this site? Confirm its status | Commack | United States | Recruiting |
| Memorial Sloan Kettering West Harrison (All Protocol Activities) Coordinator of this site? Confirm its status | Harrison | United States | Recruiting |
| Memorial Sloan Kettering Monmouth (All Protocol Activities) Coordinator of this site? Confirm its status | Middletown | United States | Recruiting |
| Memorial Sloan Kettering Bergen (All Protocol Activities) Coordinator of this site? Confirm its status | Montvale | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Memorial Sloan Kettering Nassau (All Protocol Activities) Coordinator of this site? Confirm its status | Uniondale | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.