This phase I trial compares gallium Ga 68 gozetotide prostate specific membrane antigen-positron emission tomography/computed tomography (68Gallium PSMA-PET/CT) scan and FDG-PET/CT scan for the detection of sites of cancer in patients with urothelial cancer or melanoma that has spread from where it first started (primary site) to other places in the body (metastatic). PSMA is a protein found in tumor cells and some normal cells. PSMA protein is present in prostate cancer but has been found in other cancers like bladder cancer or skin cancer. 68Gallium PSMA is a substance that gives off a small amount of radioactivity (also called radioactive tracer or radiotracer) and targets cells that carry PSMA. FDG-PET/CT scan is usually used for imaging of bladder cancer or skin cancer. The PET/CT scanner detects the radioactivity from radiotracers and takes images of the cancer. This study may help to determine if 68Gallium PSMA-PET/CT scan may better locate and provide better imaging of metastatic bladder cancer or melanoma than a standard FDG-PET/CT scan.
Additional locations may be listed on ClinicalTrials.gov for NCT05562791.
Locations matching your search criteria
United States
New York
New York
Memorial Sloan Kettering Cancer CenterStatus: Active
Contact: Gopakumar V. Iyer
Phone: 646-888-4737
PRIMARY OBJECTIVES:
I. To assess the ability of 68Gallium PSMA-PET/CT to detect metastatic urothelial carcinoma lesions.
II. To assess the ability of 68Gallium PSMA-PET/CT to detect metastatic melanoma lesions.
SECONDARY OBJECTIVES:
I. To define the concordance and discordance of assessable lesions between 68Gallium PSMA-PET/CT and standard of care fludeoxyglucose F-18 (FDG) PET/CT.
II. To define differences in concordance and discordance of assessable lesions by organ site between the two modalities.
III. To evaluate heterogeneity of gallium Ga 68 gozetotide (68Ga-PSMA-11) activity within the same lesion and between lesions based on size and location.
IV. To study the accumulation, biodistribution, and dosimetry profile of 68Ga-PSMA-11 in patients with metastatic urothelial carcinoma.
V. To study the accumulation, biodistribution, and dosimetry profile of 68Ga-PSMA-11 in patients with metastatic melanoma.
VI. To define the safety of 68Ga-PSMA-11 in patients with metastatic urothelial carcinoma.
VII. To define the safety of 68Ga-PSMA-11 in patients with metastatic melanoma.
VIII. To compare the intensity and signal-to-noise ratio of FDG versus 68Ga-PSMA-11 uptake.
IX. To define the concordance between PSMA expression by 68Gallium PSMA-PET/CT and immunohistochemistry (IHC) on formalin-fixed paraffin-embedded (FFPE) tissue for melanoma.
OUTLINE:
Patients receive standard of care (SOC) CT scan or SOC FDG intravenously (IV) with PET/CT scan. Within 10 days from SOC scan, patients receive 68Ga-PSMA-11 IV and undergo PET/CT scan on study. Additionally, patients may optionally undergo biopsy on study.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorGopakumar V. Iyer
