Bladder Cancer
Conditions
Keywords
Metastatic, Urothelial carcinoma, 68Gallium, PSMA-PET/CT, 22-157
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).
Interventions
DRUG[68Ga]PSMA
68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.
DIAGNOSTIC_TESTPET/CT imaging
68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This is a prospective, single-arm pilot study of 68Gallium PSMA-PET/CT imaging in patients with metastatic urothelial carcinoma or Melanoma.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT for Urothelial Carcinoma | 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 | 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. |
Countries
United States
Contacts
CONTACTGopakumar Iyer, MD
CONTACTAlexander Shoushtari, MD
PRINCIPAL_INVESTIGATORGopakumar Iyer
Memorial Sloan Kettering Cancer Center
Outcome results
None listed