RecruitingRecruiting
A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer or Skin Cancer
NCT05562791 · Memorial Sloan Kettering Cancer Center
In plain English
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Official title
Pilot Study of 68Gallium PSMA-PET/CT in Patients With Metastatic Urothelial Carcinoma or Melanoma
About this study
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 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 target: 20 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-09-28
Estimated completion: 2027-09
Last updated: 2026-04-22
Interventions
Drug: [68Ga]PSMADiagnostic Test: PET/CT imaging
Primary outcomes
- • Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT for Urothelial Carcinoma (1 year)
- • Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT for Melanoma (1 year)
Sponsor
Memorial Sloan Kettering Cancer Center · other
Contacts & investigators
ContactGopakumar Iyer, MD · contact · iyerg@mskcc.org · 646-888-4737
ContactAlexander Shoushtari, MD · contact · 646-888-4161
InvestigatorGopakumar Iyer · principal_investigator, Memorial Sloan Kettering Cancer Center
All locations (7)
Memorial Sloan Kettering Basking Ridge (Consent Only)Recruiting
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)Recruiting
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)Recruiting
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)Recruiting
Commack, New York, United States
Memorial Sloan Kettering West Harrison (All Protocol Activities)Recruiting
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
New York, New York, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)Recruiting
Uniondale, New York, United States