Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]PSMA | Drug | — | UNRESOLVED |
| PET/CT imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patients with metastatic urothelial carcinoma lesions
- description
- Patients will initially undergo a standard of care FDG PET with diagnostic CT scan followed by an investigational 68Ga PSMA PET/CT scan.
- interventionNames
- Drug: [68Ga]PSMA
- Diagnostic Test: PET/CT imaging
- type
- EXPERIMENTAL
- label
- Patients with melanoma lesions
- description
- Patients with melanoma who have 1 or more radiographically assessable metastatic lesions on standard of care imaging will undergo a 68Gallium PSMA-PET/CT and standard of care imaging (either FDG PET or CT scan).
- interventionNames
- Drug: [68Ga]PSMA
- Diagnostic Test: PET/CT imaging
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria for Urothelial Carcinoma Cohort: * 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 Inclusion Criteria for Melanoma Cohort: * 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 Criteria for Urothelial Carcinoma Cohort: * 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. Exclusion Criteria for Melanoma Cohort: * 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.
References
Publications (0)
Data not yet available