68Ga-PSMA PET in Diagnosing Metastasis in Patients with Ovarian Cancer

Status: Active

Description

This trial studies how well gallium Ga 68-labeled prostate specific membrane antigen (PSMA)-11 (68Ga-PSMA) positron emission tomography (PET) works in patients with ovarian cancer to detect whether the tumor has spread to other places in the body. 68Ga-PSMA is a radioactive substance that binds to blood vessels around the ovarian cancer and can be imaged using PET. Diagnostic procedures, such as PET, may help find and diagnose find out how far the disease has spread.

Eligibility Criteria

Inclusion Criteria

  • Patients with suspected or pathologically diagnosed ovarian cancer
  • Measurable disease on prior imaging (computed tomography [CT] or magnetic resonance imaging [MRI]) without interval debulking or treatment
  • Creatinine =< 1.5 mg/dL
  • Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria

  • Patients with or with a history of uncontrolled bleeding diathesis
  • Patients who have had active infection within 15 days of study enrollment
  • Pregnant or breastfeeding women
  • Patients with an inability to access an intravenous line

Locations & Contacts

California

San Francisco
UCSF Medical Center-Mount Zion
Status: Active
Contact: Michael Ohliger
Phone: 617-584-0896
Email: Michael.ohliger@ucsf.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine the feasibility and utility of 68Ga-PSMA PET imaging patients with ovarian cancer.

II. Determine detection sensitivity for nodal metastases for PSMA PET stratified by node size.

SECONDARY OBJECTIVES:

I. To assess the correlation between targeted molecular uptake of 68Ga-PSMA PET and PSMA expression in surgical resection specimens.

EXPLORATORY OBJECTIVES:

I. To explore heterogeneity of 68Ga-PSMA PET uptake in cases of metastatic ovarian cancer.

II. To determine the relationship between 68Ga-PSMA PET uptake, diffusion weighted imaging, and MRI-derived tumor perfusion.

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over 1-2 minutes. After about 60 minutes, patients undergo PET/magnetic resonance imaging (MRI) for approximately over 50-60 minutes. Patients may undergo an optional repeat gallium Ga 68-labeled PSMA-11 PET between 8 and 12 weeks after completion of the first PET/MRI.

After completion of study, patients are followed up at 28 days.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Diagnostic

Lead Organization

Lead Organization
UCSF Medical Center-Mount Zion

Principal Investigator
Michael Ohliger

Trial IDs

Primary ID 174017
Secondary IDs NCI-2018-02331, 17-23103
Clinicaltrials.gov ID NCT03857087