PSMA PET and MRI in Gynecological Cancers

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-15

Study Completion Date

2020-01-20

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.

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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.

Conditions

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Gynecologic Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Healthy Control Non-Dosimetry Group

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

Group Type OTHER

PSMA-based 18F-DCFPyL PET tracer

Intervention Type DRUG

PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer

Patient Group

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

Group Type OTHER

PSMA-based 18F-DCFPyL PET tracer

Intervention Type DRUG

PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer

Dosimetry Group

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

Group Type OTHER

PSMA-based 18F-DCFPyL PET tracer

Intervention Type DRUG

PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer

Interventions

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PSMA-based 18F-DCFPyL PET tracer

PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer

Intervention Type DRUG

Other Intervention Names

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PSMA

Eligibility Criteria

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Inclusion Criteria

* 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

* Women with or without suspected gynecological cancer.
* No contraindications for MR or PET imaging.
* Greater than or equal to 18 years of age.

* 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steve Cho, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Elizabeth Sadowski, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin, Madison

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Kunikowska J, Bizon M, Pelka K, Derlatka P, Olszewski M, Krolicki L. 68 Ga-Prostate-Specific Membrane Antigen PET/CT in Ovarian Tumors : Potential to Differentiate Benign and Malignant Tumors Before Surgery: A Preliminary Report. Clin Nucl Med. 2023 Feb 1;48(2):e60-e66. doi: 10.1097/RLU.0000000000004486. Epub 2022 Nov 18.

Reference Type DERIVED

PMID: 36512649 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document