PSMA PET and MRI in Gynecological Cancers

Phase 2TerminatedNCT03302156

University of Wisconsin, Madison15 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Gynecologic Cancer

Interventions

PSMA-based 18F-DCFPyL PET tracerDRUG

PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

University of Wisconsin, Madison

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Diagnostic Accuracy

Estimate the frequency with which PSMA PET and MR imaging and final IHC staining disagree in their classifications of presence of disease.

Time frame: up to 1 day

Secondary Outcomes

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.

Time frame: 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.

Time frame: up to 1 day

Radiodosimetry of PSMA

The radiodosimetry of PSMA-based 18F-DCFPyL will be measured in normal female controls via the resulting PET images.

Time frame: up to 1 day

Sensitivity and Specificity of PSMA-based PET/MR

Record the distribution of PSMA in cancer tissue.

Time frame: up to 1 day

Data from ClinicalTrials.gov

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