Clinical trial NCT03302156: PSMA PET and MRI in Gynecological Cancers
Official title: PSMA Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging in Gynecological Cancers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Gynecologic Cancer
Keywords: Uterine cancer
Ovarian cancer
Hysterectomy
Salpingo-oophorectomy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2017-10-04
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

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)

Primary outcomes:
measure: Diagnostic Accuracy
timeFrame: up to 1 day
Secondary outcomes:
measure: Biodistribution of PSMA Measured by SUVmax in Normal Tissue
timeFrame: up to 1 day
measure: Biodistribution of PSMA Measured by SUVmax in Cancer Tissue
timeFrame: up to 1 day
measure: Radiodosimetry of PSMA
timeFrame: up to 1 day
measure: Sensitivity and Specificity of PSMA-based PET/MR
timeFrame: up to 1 day
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin, Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Steve Cho, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: Elizabeth Sadowski, MD
role: PRINCIPAL_INVESTIGATOR
References: