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NCT Number: NCT05562791

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

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).

Recruiting

Interested in participating?

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

[68Ga]PSMA

Drug

68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.

PET/CT imaging

Diagnostic Test

68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.

Primary outcomes

  1. Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT for Urothelial Carcinoma

    Time frame: 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.

  2. Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT for Melanoma

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Shoushtari, MD

CONTACT

646-888-4161

Gopakumar Iyer, MD

CONTACT

[email protected]

646-888-4737

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Oct 3, 2022
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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