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

Last updated: January 5, 2026
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasm Metastasis

Bladder Cancer

Urothelial Carcinoma

Treatment

[68Ga]PSMA

PET/CT imaging

Clinical Study ID

NCT05562791
22-157
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 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

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 Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: [68Ga]PSMA
Phase: 1
Study Start date:
September 28, 2022
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10065
    United States

    Active - Recruiting

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