NCT03302156

PSMA PET and MRI in Gynecological Cancers

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Gynecologic Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-11-15
• Primary completion: 2020-01-20
• Completion: 2020-01-20
• First posted: 2017-10-04
• Last updated: 2023-09-05
• Results posted: 2023-08-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study