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A Study of 68Gallium PSMA-PET/CT Scans in Patients with Metastatic Bladder Cancer or Melanoma
Trial Status: active
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.
Inclusion Criteria
UROTHELIAL CARCINOMA PATIENTS: Patients with histologically confirmed metastatic urothelial carcinoma with extrapelvic nodal and/or visceral sites of disease (including lung, liver, bone, or soft tissue)
UROTHELIAL CARCINOMA PATIENTS: At least 1 lesion assessable by FDG PET/CT according to Response Evaluation Criteria in Solid Tumors (RECIST) and PET Response Criteria in Solid Tumors (PERCIST) guidelines where applicable, that are determined suspicious for metastasis by a Memorial Sloan Kettering Cancer Center (MSKCC) attending radiologist or nuclear medicine physician
UROTHELIAL CARCINOMA PATIENTS: Karnofsky performance status >= 50% (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] =< 2)
UROTHELIAL CARCINOMA PATIENTS: Participant is >= 18 years of age
UROTHELIAL CARCINOMA PATIENTS: Patient must be able to understand and is willing to sign a written informed consent document
MELANOMA PATIENTS: Patients with histologically confirmed metastatic melanoma
MELANOMA PATIENTS: 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
MELANOMA PATIENTS: ECOG <= 2
MELANOMA PATIENTS: Participant is >= 18 years of age
MELANOMA PATIENTS: Patient must be able to understand and is willing to sign a written informed consent
document
Exclusion Criteria
UROTHELIAL CARCINOMA PATIENTS: 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
UROTHELIAL CARCINOMA PATIENTS: Patients with bone only disease
UROTHELIAL CARCINOMA PATIENTS: Unable to lie flat, still, or to tolerate a PET scan
UROTHELIAL CARCINOMA PATIENTS: Patient undergoing active treatment for non-urothelial malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized
UROTHELIAL CARCINOMA PATIENTS: Patients on a therapeutic clinical trial where PSMA imaging would interfere with the conduct of the trial
UROTHELIAL CARCINOMA PATIENTS: Patients undergoing active surveillance with a known history of non-urothelial malignancies
UROTHELIAL CARCINOMA PATIENTS: Women who are pregnant. All women of childbearing potential must have a documented negative pregnancy test
MELANOMA PATIENTS: Unable to lie flat, still, or tolerate PET scan
MELANOMA PATIENTS: Patient is on another therapeutic trial where PSMA imaging would interfere with the conduct of the trial
MELANOMA PATIENTS: Women who are pregnant. All women of childbearing potential must have a documented negative pregnancy test
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05562791.
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 1 to 28 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.
Trial PhasePhase I
Trial Typediagnostic
Lead OrganizationMemorial Sloan Kettering Cancer Center
