Gallium Ga 68-labeled PSMA-11 PET / MRI in Diagnosing Participants with PSMA-positive Tumors

Status: Active

Description

This pilot trial studies how well gallium Ga 68-labeled prostate-specific membrane antigen (PSMA)-11 positron-emission tomography (PET) / magnetic resonance imaging (MRI) works in diagnosing participants with PSMA-positive tumors. Gallium Ga 68-labeled PSMA- is an imaging drug that binds to tumor cells and can be imaged using PET / MRI. Diagnostic procedures, such as gallium Ga 68-labeled PSMA-11 PET / MRI, may help find the presence of cancer.

Eligibility Criteria

Inclusion Criteria

  • Patients with PSMA-positive tumors including prostate cancer, breast cancer, lung cancer, and other tumor types know to express PSMA
  • Patients able to tolerate PET/MRI scans
  • Informed consent must be given and signed

Exclusion Criteria

  • Subjects who do not meet the above mentioned inclusion criteria
  • Subjects who refuse to give and/or sign the informed consent
  • Patients who have a history of serious adverse events related to a previous MRI or PET/computed tomography (CT)
  • Patients who are unable to undergo MRI scanning due to exclusion by University Hospitals Case Medical Center (UHCMC) MRI restriction policies as mentioned in the standard UHCMC MRI informed consent form
  • Patients who are currently pregnant or breast feeding; a pregnancy test within 72 hours of the first PET/MRI will be performed
  • Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks
  • Elevated creatinine and/or glomerular filtration rate (GFR) < 40 ml/min/1.7 sqm (exclusion criterion only for contrast enhanced MRI)
  • Patients with a known allergy against any component of the contrast enhancing MR agent will not receive MR contrast agents; (exclusion criterion only for contrast enhanced MRI)

Locations & Contacts

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: Active
Contact: Norbert Avril
Phone: 216-286-3210
Email: Norbert.Avril@UHhospitals.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine the feasibility of using PET/magnetic resonance (MR) with gallium Ga 68 (Ga-68) PSMA for staging and treatment monitoring of PSMA expressing tumors.

SECONDARY OBJECTIVES:

I. To compare early changes in PET biomarker ([Ga-68] PSMA) tumor uptake with treatment response assessed at completion of therapy (prediction of treatment response).

II. To compare changes in MRI signal intensities (multi-parametric MRI) with treatment response assessed at completion of therapy.

III. To compare results from multi-parametric MR imaging with [Ga-68] PSMA uptake.

IV. To assess combinations of quantitative PET and MRI metrics.

OUTLINE:

Participants receive gallium Ga 68-labeled PSMA-11 intravenously (IV). Participants undergo PET/MRI over 90 minutes at baseline and 2-6 weeks after start of treatment. Participants may undergo optional PET/MRI before the start of treatment.

After completion of study, participants are followed up for up to 30 days.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Diagnostic

Lead Organization

Lead Organization
Case Comprehensive Cancer Center

Principal Investigator
Norbert Avril

Trial IDs

Primary ID CASE7Y16
Secondary IDs NCI-2018-00468
Clinicaltrials.gov ID NCT02978586