Efficacy of PET/MRI in Detecting Metastatic Disease in Endometrial Cancer

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02765698

Enrollment

Registered

2016-05-09

Start date

2016-05-31

Completion date

2018-03-31

Last updated

2018-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

Keywords

Magnetic Resonance Imaging

Brief summary

The purpose of this study is to evaluate the ability of PET/MRI (Positron Emission Tomography/Magnetic Resonance Imaging) to give physicians preoperative information about specific sites in the body that the endometrial cancer may be present. If the PET/MRI is accurate and successful in providing this information, then women in the future may be able to have less extensive surgery for their endometrial cancer after evaluation with PET/MRI.

Detailed description

PET/MRI has recently become available at the institution and reports of its sensitivity, specificity, NPV (Negative predictive value) , PPV (Positive predictive value), and accuracy in endometrial cancer are not found in the literature to date, to the best of the investigator's knowledge. The GE PET/MRI recently obtained here at Mayo, Rochester has the potential to improve the sensitivity of detection of metastatic disease, compared to other imaging modalities, because of its superior PET technology and updated Q Clear software. For these reasons it is reasonable to expect improved sensitivity to detect metastatic disease in endometrial cancer, possibly proving PET/MRI to be a superior modality for preoperative screening and potentially allowing for less morbid surgical management for patients with high risk endometrial cancer.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Biopsy-proven high-risk endometrial cancer (type 2 or grade 3 endometrioid histology) * BMI of at least 18.5 kg/m2 and less than 35 kg/m2 or axial diameter less than 25 cm * Patients who pass standard clinical MRI screening procedures * Receiving preoperative clinical evaluation at Mayo Clinic, Rochester, MN * Undergoing surgical staging and/or debulking at Mayo Clinic in Rochester, MN

Exclusion criteria

* Allergy to FDG or gadolinium * Contraindication to MRI scanning (Extreme claustrophobia preventing PET/MRI completion, patients who are unable to lay quietly for an additional 60 minutes of imaging * Known kidney disease or poor renal function * Pregnant

Design outcomes

Primary

Measure	Time frame	Description
Detection of distant metastasis of endometrial cancer by PET/MRI	one month	Preoperative PET/MRI will be read by a radiologist and compared to final pathologic evaluation of metastatic specimens in high risk endometrial cancer patients.

Countries

United States

Outcome results