Ovarian Cancer Clinical Trial

PSMA PET and MRI in Gynecological Cancers

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.

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Full 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.

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Eligibility Criteria

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 is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

15

Study ID:

NCT03302156

Recruitment Status:

Terminated

Sponsor:

University of Wisconsin, Madison

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There is 1 Location for this study

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

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

15

Study ID:

NCT03302156

Recruitment Status:

Terminated

Sponsor:


University of Wisconsin, Madison

How clear is this clinincal trial information?

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