Pilot Study of 68Gallium PSMA-PET/CT in Patients With Metastatic Urothelial Carcinoma or Melanoma
Overview
- Phase
- Phase 1
- Intervention
- PET/CT imaging
- Conditions
- Bladder Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 20
- Locations
- 8
- Primary Endpoint
- Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT for Urothelial Carcinoma
- Status
- Recruiting
- Last Updated
- 10 days ago
Overview
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).
Investigators
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
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.
Arms & Interventions
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).
Intervention: PET/CT imaging
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.
Intervention: PET/CT imaging
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).
Intervention: [68Ga]PSMA
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.
Intervention: [68Ga]PSMA
Outcomes
Primary Outcomes
Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT for Urothelial Carcinoma
Time Frame: 1 year
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.
Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT for Melanoma
Time Frame: 1 year
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.