PSMA PET and MRI in Gynecological Cancers

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gynecologic Cancer

Intervention / Treatment
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* Drug: PSMA-based 18F-DCFPyL PET tracer


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy Control Non-Dosimetry Group<br>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 | Drug: PSMA-based 18F-DCFPyL PET tracer<br>* PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer<br>* Other names: PSMA;|
| Other: Patient Group<br>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 | Drug: PSMA-based 18F-DCFPyL PET tracer<br>* PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer<br>* Other names: PSMA;|
| Other: Dosimetry Group<br>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 | Drug: PSMA-based 18F-DCFPyL PET tracer<br>* PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer<br>* Other names: PSMA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Sensitivity and Specificity of PSMA-based PET/MR | Record the distribution of PSMA in cancer tissue. | up to 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterine cancer, Ovarian cancer, Hysterectomy, Salpingo-oophorectomy