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NCT05562791 | RECRUITING | Bladder Cancer

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

Memorial Sloan Kettering Cancer Center

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).

Condition or disease

Bladder Cancer

Intervention/treatment

[68Ga]PSMA

PET/CT imaging

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : Pilot Study of 68Gallium PSMA-PET/CT in Patients With Metastatic Urothelial Carcinoma or Melanoma
Actual Study Start Date : 2022-09-28
Estimated Primary Completion Date : 2026-09
Estimated Study Completion Date : 2026-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer or Skin Cancer

Location Details

NCT05562791

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Locations

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065