Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05562791

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

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-22

20

Participants Needed

7

Research Sites

257 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years or older
  • For urothelial carcinoma: confirmed metastatic urothelial carcinoma with extrapelvic nodal and/or visceral disease sites
  • At least one lesion assessable by FDG PET/CT suspicious for metastasis
  • Karnofsky performance status 50% or higher (or ECOG/WHO 2 or lower)
  • For melanoma: confirmed metastatic melanoma
  • At least one metastatic lesion assessable by CT or FDG PET/CT suspicious for metastasis
  • ECOG performance status 2 or lower
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • For urothelial carcinoma: only pelvic lymph node metastatic disease without nodes outside pelvis
  • Bone only metastatic disease
  • Unable to lie flat, stay still, or tolerate PET scan
  • Active treatment for non-urothelial malignancy except non-metastatic skin basal cell or superficial squamous cell carcinoma
  • Participation in therapeutic clinical trial that interferes with PSMA imaging
  • Active surveillance for non-urothelial malignancies
  • Pregnant women or women of childbearing potential without negative pregnancy test
  • For melanoma: unable to lie flat, stay still, or tolerate PET scan
  • Participation in therapeutic trial interfering with PSMA imaging
  • Pregnant women or women of childbearing potential without negative pregnancy test

AI-Screening

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Trial Site Locations

Total: 7 locations

1

Memorial Sloan Kettering Basking Ridge (Consent Only)

Basking Ridge, New Jersey, United States, 10065

Actively Recruiting

2

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

3

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States, 07645

Actively Recruiting

4

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

Commack, New York, United States, 11725

Actively Recruiting

5

Memorial Sloan Kettering West Harrison (All Protocol Activities)

Harrison, New York, United States, 10604

Actively Recruiting

6

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

Actively Recruiting

7

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, United States, 11553

Actively Recruiting

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Research Team

G

Gopakumar Iyer, MD

CONTACT

A

Alexander Shoushtari, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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