PSMA PET and MRI in Gynecological Cancers

PSMA Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging in Gynecological Cancers

The goal of this research is to determine the accuracy of PSMA positron emission tomography (PET) and multi-parametric magnetic resonance (MR) imaging to detect the presence of gynecological cancer cells in the body.

Study Overview

• Status: Terminated
• Conditions: Gynecologic Cancer
• Intervention / Treatment: Drug: PSMA-based 18F-DCFPyL PET tracer

Detailed Description

The investigators will evaluate a novel second-generation low-molecular-weight prostate specific membrane antigen (PSMA)-based positron emission tomography (PET) agent, 18F-DCFPyL, to determine the presence or absence of cancer, the accurate distribution of cancer and the normal biodistribution of PSMA in the abdomen and pelvis on PET imaging.

PSMA, also known as folate hydrolase 1 and glutamate carboxypeptidase II, is an enzyme associated with prostate cancer but has been also found to be expressed in the tumor neovasculature of many different types of non-prostate cancer tumors. PSMA-based 18F-DCFPyL PET demonstrates very high tumor-to-background ratio when studied in other tumors, including prostate tumors.

MR imaging is a highly sensitive and specific imaging modality that can be used for gynecologic cancers. MR images can be obtained in conjunction with PSMA PET, adding additional anatomic and multi-parametric MRI information without the need for a second imaging appointment.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin, Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for healthy female controls N=12 (includes up to 6 Dosimetry participants):

• Women with no suspected gynecological cancer.
• No contraindications for MR or PET imaging.
• Greater than or equal to 18 years of age.
• Scheduled to undergo a hysterectomy and/or salpingo-oophorectomy

Inclusion Criteria for female controls (Dosimetry):

• Women with or without suspected gynecological cancer.
• No contraindications for MR or PET imaging.
• Greater than or equal to 18 years of age.

Inclusion Criteria for gynecological cancer patients (N=40):

• Women with known or suspected gynecological cancer
• No contraindications for MR or PET imaging.
• Greater than or equal to 18 years
• Have had or are scheduled to undergo a hysterectomy and/or salpingo-oophorectomy

Exclusion Criteria:

• Women that are pregnant or breast-feeding.
• Age <18
• Inability to provide informed consent on their own behalf
• Severe kidney dysfunction (GFR <30 mL/min/1.73m2)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy Control Non-Dosimetry Group; The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6	Drug: PSMA-based 18F-DCFPyL PET tracer; PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer; Other Names: PSMA
Other: Patient Group; The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40	Drug: PSMA-based 18F-DCFPyL PET tracer; PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer; Other Names: PSMA
Other: Dosimetry Group; Women with or without suspected gynecological cancer. Women will receive PSMA-based 18F-DCFPyL tracer and PET/CT imaging, PET/MR imaging as needed. n=6	Drug: PSMA-based 18F-DCFPyL PET tracer; PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer; Other Names: PSMA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Accuracy	Estimate the frequency with which PSMA PET and MR imaging and final IHC staining disagree in their classifications of presence of disease.	up to 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiodosimetry of PSMA	The radiodosimetry of PSMA-based 18F-DCFPyL will be measured in normal female controls via the resulting PET images.	up to 1 day
Biodistribution of PSMA Measured by SUVmax in Normal Tissue	Record the normal biodistribution of PSMA as detected in normal tissue controls, by the resulting PET imaging.	up to 1 day
Biodistribution of PSMA Measured by SUVmax in Cancer Tissue	Record the biodistribution of PSMA as detected in cancer tissue, by the resulting PET imaging.	up to 1 day
Sensitivity and Specificity of PSMA-based PET/MR	Record the distribution of PSMA in cancer tissue.	up to 1 day

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Steve Cho, MD, University of Wisconsin, Madison; Principal Investigator: Elizabeth Sadowski, MD, University of Wisconsin, Madison

Publications and helpful links

Helpful Links

• University of Wisconsin Carbone Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2017
• Primary Completion (Actual): January 20, 2020
• Study Completion (Actual): January 20, 2020

Study Registration Dates

• First Submitted: August 18, 2017
• First Submitted That Met QC Criteria: September 29, 2017
• First Posted (Actual): October 4, 2017

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Ovarian cancer; Salpingo-oophorectomy; Hysterectomy; Uterine cancer
• Other Study ID Numbers: UW17017; A539300 (Other Identifier: UW- Madison); SMPH\RADIOLOGY\RADIOLOGY (Other Identifier: UW Madison); 2017-0456 (Other Identifier: Institutional Review Board); NCI-2018-00466 (Registry Identifier: NCI Trial ID); 06-08-2020 (Other Identifier: Protocol Version Date)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No