PSMA PET and MRI in Gynecological Cancers

University of Wisconsin (UW)

Status and phase: Terminated; Phase 2

Conditions: Gynecologic Cancer

Treatments: Drug: PSMA-based 18F-DCFPyL PET tracer

Study type: Interventional

Funder types: Other

Identifiers

NCT03302156

NCI-2018-00466 (Registry Identifier)

UW17017

06-08-2020 (Other Identifier)

2017-0456 (Other Identifier)

A539300 (Other Identifier)

SMPH\RADIOLOGY\RADIOLOGY (Other Identifier)

Details and patient eligibility

About

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.

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.

Enrollment: 15 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Healthy Control Non-Dosimetry Group

Other group

Description:

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

Treatment:

Drug: PSMA-based 18F-DCFPyL PET tracer

Patient Group

Other group

Description:

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

Treatment:

Drug: PSMA-based 18F-DCFPyL PET tracer

Dosimetry Group

Other group

Description:

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

Treatment:

Drug: PSMA-based 18F-DCFPyL PET tracer