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

NCT02765698 | Terminated

• 1 other identifier: 15-004593
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer

Keywords

Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with biopsy-proven high risk (type 2 or grade 3 endometrioid histology) endometrial cancer undergoing debulking surgery.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Andrea Mariani

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: May 9, 2016
• Study Start: May 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 27, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)