A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer or Skin Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [68Ga]PSMA, PET/CT imaging.
- Who it may be relevant to
- Registry conditions: Bladder Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Study of 68Gallium PSMA-PET/CT in Patients With Metastatic Urothelial Carcinoma or Melanoma
Overview
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).
Interventions
- 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.
Primary outcome measures
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 7 centers
- Memorial Sloan Kettering Basking Ridge (Consent Only) — Basking Ridge
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown
- Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale
- Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) — Commack
- Memorial Sloan Kettering West Harrison (All Protocol Activities) — Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
- Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale
Identifiers
NCT: NCT05562791 · 22-157