Summary

for females ages 18 years and up (full criteria)
at San Francisco, California
study started
estimated completion
Michael Ohliger

Description

Summary

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.

Official Title

Gallium-68 Prostate Specific Membrane Antigen for Ovarian Cancer: A Pilot Feasibility Study

Details

PRIMARY OBJECTIVES:

  1. 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:

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

EXPLORATORY OBJECTIVES:

  1. 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.

Keywords

Ovarian CarcinomaOvarian NeoplasmsCarcinoma, Ovarian EpithelialEdetic AcidGallium Ga 68-labeled PSMA-11Magnetic Resonance ImagingPositron Emission Tomography

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Location

  • UCSF Medical Center-Mount Zionaccepting new patients
    San FranciscoCalifornia94115United States

Lead Scientist

  • Michael Ohliger
    Michael Ohliger, MD, PhD, is an Associate Professor in Residence in the Department of Radiology and Biomedical Imaging at the University of California, San Francisco.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03857087
Phase
Phase 1
Study Type
Interventional
Last Updated