Brief Title
Efficacy of PET/MRI in Detecting Metastatic Disease in Endometrial Cancer
Official Title
Efficacy of PET/MRI in Detecting Metastatic Disease in Endometrial Cancer
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.
Study Type
Observational
Primary Outcome
Detection of distant metastasis of endometrial cancer by PET/MRI
Condition
Endometrial Cancer
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
2
Start Date
May 2016
Completion Date
March 2018
Primary Completion Date
March 2018
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Andrea Mariani, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02765698
Organization ID
15-004593
Responsible Party
Principal Investigator
Study Sponsor
Mayo Clinic
Study Sponsor
Andrea Mariani, Principal Investigator, Mayo Clinic
Verification Date
March 2018