Recruiting

Phase 1

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

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05562791

Conditions

Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[68Ga]PSMA

PET/CT imaging

Study Details

Brief 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).

Conditions

Bladder Cancer

Study ID

NCT05562791

Start date

Sep 28, 2022

Status verified date

Apr, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

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).

Interventions

[68Ga]PSMA

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

PET/CT imaging

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

Primary outcome measure

Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT for Urothelial Carcinoma [ Time Frame: 1 year ]
Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT for Melanoma [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Gopakumar Iyer, MD

646-888-4737 iyerg@mskcc.org

Alexander Shoushtari, MD

646-888-4161

Locations

Memorial Sloan Kettering Basking Ridge (Consent Only)

Recruiting

Basking Ridge, New Jersey, United States, 10065

Contacts

Gopakumar Iyer, MD

646-888-4737

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Gopakumar Iyer, MD

646-888-4737

Memorial Sloan Kettering Bergen (All Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Gopakumar Iyer, MD

646-888-4737

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Gopakumar Iyer, MD

646-888-4737

Memorial Sloan Kettering West Harrison (All Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Gopakumar Iyer, MD

646-888-4737

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Gopakumar Iyer, MD

646-888-4737

Alexander Shoushtar, MD

646-888-4161

Principal Investigator:

Gopakumar Iyer, MD

Memorial Sloan Kettering Nassau (All Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Gopakumar Iyer, MD

646-888-4737

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

Metastatic
Urothelial carcinoma
68Gallium
PSMA-PET/CT
22-157

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-04-22.