Phase
Condition
Neoplasm Metastasis
Bladder Cancer
Urothelial Carcinoma
Treatment
[68Ga]PSMA
PET/CT imaging
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 3 lesions 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
Connect with a study center
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065
United StatesActive - Recruiting

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