RecruitingPhase 1NCT05562791

A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer or Skin Cancer

Pilot Study of 68Gallium PSMA-PET/CT in Patients With Metastatic Urothelial Carcinoma or Melanoma

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

20 participants

Start Date

Sep 28, 2022

Study Type

INTERVENTIONAL

Conditions

Bladder Cancer

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria10

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
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 Criteria10

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.
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.