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

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).

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer
• Intervention / Treatment: Drug: [68Ga]PSMA; Diagnostic test: PET/CT imaging

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Gopakumar Iyer, MD; Phone Number: 646-888-4737; Email: iyerg@mskcc.org
• Study Contact Backup: Name: Alexander Shoushtari, MD; Phone Number: 646-888-4161

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Basking Ridge (Consent Only)
      • Contact: Gopakumar Iyer, MD; Phone Number: 646-888-4737
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth (All Protocol Activities)
      • Contact: Gopakumar Iyer, MD; Phone Number: 646-888-4737
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen (All Protocol Activities)
      • Contact: Gopakumar Iyer, MD; Phone Number: 646-888-4737
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
      • Contact: Gopakumar Iyer, MD; Phone Number: 646-888-4737
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering West Harrison (All Protocol Activities)
      • Contact: Gopakumar Iyer, MD; Phone Number: 646-888-4737
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
      • Contact: Gopakumar Iyer, MD; Phone Number: 646-888-4737
      • Principal Investigator: Gopakumar Iyer, MD
      • Contact: Alexander Shoushtar, MD; Phone Number: 646-888-4161
    • Uniondale, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau (All Protocol Activities)
      • Contact: Gopakumar Iyer, MD; Phone Number: 646-888-4737

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with metastatic urothelial carcinoma lesions; Patients will initially undergo a standard of care FDG PET with diagnostic CT scan followed by an investigational 68Ga PSMA PET/CT scan.	Drug: [68Ga]PSMA; 68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.; Diagnostic test: PET/CT imaging; 68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.
Experimental: Patients with melanoma lesions; 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).	Drug: [68Ga]PSMA; 68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.; Diagnostic test: PET/CT imaging; 68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Gopakumar Iyer, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2022
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Metastatic; Urothelial carcinoma; 68Gallium; PSMA-PET/CT; 22-157
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplastic Processes; Urologic Neoplasms; Carcinoma; Urinary Bladder Diseases; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; gallium 68 PSMA-11
• Other Study ID Numbers: 22-157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No