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
1 other identifier
interventional
20
1 country
7
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2022
Longer than P75 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2022
CompletedStudy Start
First participant enrolled
September 28, 2022
CompletedFirst Posted
Study publicly available on registry
October 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
April 22, 2026
April 1, 2026
4.9 years
September 28, 2022
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Patients with metastatic urothelial carcinoma lesions
EXPERIMENTALPatients will initially undergo a standard of care FDG PET with diagnostic CT scan followed by an investigational 68Ga PSMA PET/CT scan.
Patients with melanoma lesions
EXPERIMENTALPatients 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
68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.
68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 10065, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering West Harrison (All Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gopakumar Iyer
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2022
First Posted
October 3, 2022
Study Start
September 28, 2022
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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.