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Trial record 9 of 163 for:    PSMA

PSMA PET and MRI in Gynecological Cancers

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ClinicalTrials.gov Identifier: NCT03302156
Recruitment Status : Recruiting
First Posted : October 4, 2017
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief 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.

Condition or disease Intervention/treatment Phase
Gynecologic Cancer Drug: PSMA-based 18F-DCFPyL PET tracer Phase 2

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PSMA Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging in Gynecological Cancers
Actual Study Start Date : August 10, 2017
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Control Group
The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy.
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
Other Name: PSMA

Patient Group
The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy
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
Other Name: PSMA




Primary Outcome Measures :
  1. Diagnostic accuracy [ Time Frame: Up to 24 months ]
    Estimate the frequency with which PSMA PET and MR imaging and final IHC staining disagree in their classifications of presence of disease.


Secondary Outcome Measures :
  1. Biodistribution of PSMA [ Time Frame: Up to 24 months ]
    Record the normal biodistribution of PSMA as detected in normal female controls, by the resulting PET imaging.

  2. Radiodosimetry of PSMA [ Time Frame: Up to 24 months ]
    The radiodosimetry of PSMA-based 18F-DCFPyL will be measured in normal female controls via the resulting PET images.

  3. Sensitivity and specificity of PSMA-based PET/MR [ Time Frame: Up to 24 months ]
    Record the distribution of PSMA in cancer tissue.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This research will only target women as the investigation is targeting gynecological cancers.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women with no suspected gynecological cancer and women with 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

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302156


Contacts
Contact: Gemma Gliori, MS 608-262-7269 ggliori@uwhealth.org
Contact: Molly Ellertson, BSN 608-265-4840 mellertson@uwhealth.org

Locations
United States, Wisconsin
University of Wisconsin, Madison Recruiting
Madison, Wisconsin, United States, 53705
Contact: Gemma Gliori, MS    608-262-7269    ggliori@uwhealth.org   
Principal Investigator: Steve Cho, MD         
Principal Investigator: Elizabeth Sadowski, MD         
Principal Investigator: Lisa Barroilhet, MD         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Steve Cho, MD University of Wisconsin, Madison
Principal Investigator: Elizabeth Sadowski, MD University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03302156     History of Changes
Other Study ID Numbers: 2017-0456
UW17017 ( Other Identifier: University of Wisconsin Carbone Cancer Center )
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Wisconsin, Madison:
Uterine cancer
Ovarian cancer
Hysterectomy
Salpingo-oophorectomy