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

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02765698
• Other study ID #: 15-004593
• Status: Terminated
• First received: May 5, 2016
• Last updated: March 26, 2018
• Start date: May 2016
• Est. completion date: March 2018

Study information

• Verified date: March 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Neoplasm Metastasis

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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