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RecruitingInterventionalPhase 1

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

NCT ID: NCT05562791Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2026-04-22

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 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).

Arms & interventions

  • Drug[68Ga]PSMA

    68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.

  • Diagnostic TestPET/CT imaging

    68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.

Outcome measures

Primary

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

    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.

    Time frame: 1 year

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

    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.

    Time frame: 1 year

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (7)

Memorial Sloan Kettering Basking Ridge (Consent Only)

Basking Ridge, New Jersey, 10065

Recruiting
Gopakumar Iyer, MD · Contact

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748

Recruiting
Gopakumar Iyer, MD · Contact

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645

Recruiting
Gopakumar Iyer, MD · Contact

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

Commack, New York, 11725

Recruiting
Gopakumar Iyer, MD · Contact

Memorial Sloan Kettering West Harrison (All Protocol Activities)

Harrison, New York, 10604

Recruiting
Gopakumar Iyer, MD · Contact

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

Recruiting
Gopakumar Iyer, MD · Contact
Alexander Shoushtar, MD · Contact
Gopakumar Iyer, MD · Principal Investigator

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, 11553

Recruiting
Gopakumar Iyer, MD · Contact