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


  • Org Study ID: 22-157
  • Secondary ID: N/A
  • NCT ID: NCT05562791
  • Sponsor: Memorial Sloan Kettering Cancer Center


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. 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 (FDG-PET/CT scan).

  • Overall Status
  • Start Date
    September 28, 2022
  • Phase
    Phase 1
  • Study Type


Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A


  • Bladder Cancer


Inclusion Criteria:
* 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
Exclusion Criteria:
* 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

- * 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No


Name: Gopakumar Iyer

Role: Principal Investigator

Affiliation: Memorial Sloan Kettering Cancer Center

Overall Contact

Name: Gopakumar Iyer, MD, Michael Morris, MD

Phone: 646-888-4737, 646-422-4469

Email: iyerg@mskcc.org


Facility Status Contact
Facility: Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Status: Recruiting Contact: Contact
Gopakumar Iyer, MD

Michael Morris, MD

Principal Investigator
Gopakumar Iyer, MD