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

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

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.

Study Overview

• Status: Completed
• Conditions: Ovarian Carcinoma
• Intervention / Treatment: Drug: Gallium Ga 68-labeled PSMA-11; Procedure: Magnetic Resonance Imaging (MRI); Procedure: Positron Emission Tomography (PET)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The patient population will be women with adnexal masses or other lesions suspicious for ovarian cancer metastases, who are scheduled for either resection or chemotherapy

Description

Inclusion Criteria:

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)
2. Female,
3. Age >= 18 years
4. Creatinine </= 1.5 mg/dL
5. Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Diagnostic 68Ga PSMA PET/MRI; Patients receive gallium Ga 68-labeled PSMA-11 IV over 1-2 minutes. After about 60 minutes, patients undergo PET/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.

Drug: Gallium Ga 68-labeled PSMA-11; Given IV; Other Names: (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC; (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC; (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC; (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC; 68Ga-HBED-CC-PSMA; 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC; 68Ga-PSMA-11; [68Ga] Prostate-specific Membrane Antigen 11; [68Ga]GaPSMA-11; Ga-68 labeled PSMA-11; Gallium Ga 68 PSMA-11; Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC; PSMA-HBED-CC GA-68; Procedure: Magnetic Resonance Imaging (MRI); Given PET/MRI; Other Names: MRI; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MRI Scan; NMR Imaging; NMRI; Magnetic Resonance Imaging; Nuclear Magnetic Resonance Imaging (NMRI); Procedure: Positron Emission Tomography (PET); Undergo PET/MRI; Other Names: Medical Imaging, Positron Emission Tomography; PET; PET Scan; Positron Emission Tomography Scan; Positron-Emission Tomography; proton magnetic resonance spectroscopic imaging; Positron Emission Tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of gallium Ga 68-labeled PSMA-11 positron emission tomography (PET) positive lesions detected by standard staging scans	Will be descriptively reported for each patient and correlated with the lesions observed in standard imaging computed tomography/magnetic resonance imaging (CT/MRI). In addition, the mean, range, and standard deviation of standardized uptake value maximum (SUVmax) (across all visualized lesions per patient) and SUVmax-average (ave) (across all patients in the study cohort) will be descriptively reported.	Study Visit Day 1
Number of overall ovarian cancer lesions detected by standard staging scans	Will be descriptively reported for each patient and correlated with the lesions observed in standard imaging CT/MRI.	Study Visit Day 1
Average maximum standard uptake value (SUVmax)	The mean, range, and standard deviation of SUVmax across all visualized lesions per patient will be descriptively reported.	Study Visit Day 1
Number of lymph nodes detected by PET	Will be compared and stratified by lymph node size. For patients undergoing surgical resection, this will be compared with the number of involved lymph nodes by surgical resection. For lymph nodes that are not resected, the behavior on follow-up clinical CT scans (if available) will be used to assess for involvement.	Study Visit Day 1
Number of lymph nodes detected by MRI	Will be compared and stratified by lymph node size. For patients undergoing surgical resection, this will be compared with the number of involved lymph nodes by surgical resection. For lymph nodes that are not resected, the behavior on follow-up clinical CT scans (if available) will be used to assess for involvement.	Study Visit Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between targeted molecular uptake of 68Ga-PSMA PET and prostate-specific membrane antigen (PSMA) expression in surgical resection specimens	For patients undergoing surgical resection, the 68Ga PSMA-PET uptake will be correlated with PSMA expression in the primary tumor as well as metastatic sites. PSMA expression measurement is available as a core service from the cancer center	Study Visit Day 1

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Radiological Society of North America
• Investigators: Principal Investigator: Michael Ohliger, MD, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2018
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Anticoagulants; Chelating Agents; Sequestering Agents; Calcium Chelating Agents; Edetic Acid; Gallium 68 PSMA-11
• Other Study ID Numbers: 174017; NCI-2018-02331 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No