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

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

Recruiting
18 years and older
All
Phase 1

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Overview

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. 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 (FDG-PET/CT scan).

Eligibility

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Study details
    Bladder Cancer

NCT05562791

Memorial Sloan Kettering Cancer Center

27 January 2024

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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