PSMA PET and MRI in Gynecological Cancers

Gynecologic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03302156
• Other study ID #: UW17017
• Secondary ID: 2017-0456A539300
• Status: Terminated
• Phase: Phase 2
• Start date: November 15, 2017
• Est. completion date: January 20, 2020

Study information

• Verified date: July 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: January 20, 2020
• Est. primary completion date: January 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Gynecologic Cancer

Intervention

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

Locations

Country	Name	City	State
United States	University of Wisconsin, Madison	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Sensitivity and Specificity of PSMA-based PET/MR	Record the distribution of PSMA in cancer tissue.	up to 1 day

External Links

•   University of Wisconsin Carbone Cancer Center