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

a study on Ovarian Cancer

Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Michael Ohliger
Headshot of Michael Ohliger
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: 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.

Keywords

Ovarian Carcinoma Edetic Acid Gallium 68 PSMA-11 Gallium Ga 68-labeled PSMA-11 Magnetic Resonance Imaging (MRI) Positron Emission Tomography (PET)

Eligibility

You can join if…

Open to females ages 18 years and up

  1. Patients with one of the following, identified on prior imaging (CT, MRI or

Ultrasound):

  1. adnexal mass
  2. abdominal or pelvic tumor suspicious for ovarian cancer metastases (either suspected on clinical grounds, or known from prior tissue sampling)
  3. Female,
  4. Age >= 18 years
  5. Creatinine </= 1.5 mg/dL
  6. Ability to understand a written informed consent document, and the willingness to sign it

You CAN'T join if...

  1. Pregnant or breastfeeding women
  2. Patient unlikely to comply with study procedure, restrictions and requirements and judged by the investigator to be unsuitable for study participation.

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94115 United States

Lead Scientist at UCSF

  • 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. Dr. Ohliger obtained his PhD in Medical Physics from the Massachusetts Institute of Technology Harvard/MIT Division of Health Sciences and Technology in 2005, and he received his MD in Medicine from Harvard Medical School in 2007.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03857087
Study Type
Observational
Participants
Expecting 20 study participants
Last Updated
Contact us about this trial