The Value of Advanced MR Imaging in Gynecological Tumors and Benign Uterine Fibroids
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Gynecologic Tumor
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 1
- Locations
- 2
- Primary Endpoint
- Number of Patients With Feasible Imaging
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
This research is being done to test new MRI methods called Magnetic Resonance Fingerprinting and Q-space Trajectory Imaging in gynecological abnormalities. The purpose of this research study is to evaluate if these new MRI methods can give additional information in characterizing gynecological tumors compared with conventional MRI.
Detailed Description
Magnetic resonance imaging (MRI) is a safe and painless test that uses a magnetic field and radio waves to produce detailed images of the body's organs and structures. This research is being done to test new MRI methods called Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) in gynecological abnormalities. The purpose of this research study is to evaluate if these new MRI methods can give additional information in characterizing gynecological tumors compared with conventional MRI In this research study, the investigators are: * Investigating the use of MR imaging in gynecological tumors on imaging quality and comparison of tumor or fibroid structures and normal anatomy * Investigating whether new MRI methods could help in characterizing the tumor and give information about the expected outcome
Investigators
Clare Tempany
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
Inclusion Criteria
- •Participants with suspected or histologically confirmed diagnosis of primary or recurrent gynecological cancer including uterine endometrial, cervical, vaginal, vulvar, ovarian, and smooth-muscle tumors undergoing routine clinical standard of care pelvic MRI
- •Control subjects with benign fibroids undergoing routine clinical standard of care pelvic MRI
- •Age ≥ 18 years
- •ECOG performance status of ≤ 2, based on treating physician's discretion (Appendix A)
- •Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
- •Contraindication to MRI identified by the MR procedure screening form, such as a pacemaker, aneurysm clip, inner ear implant, neurostimulator, or other MR non-compatible device or implant
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Adults unable to consent
- •Non-english speaking subjects
- •Pregnant women
- •Prisoners
Outcomes
Primary Outcomes
Number of Patients With Feasible Imaging
Time Frame: Day 1
Feasibility is determined by both A) having evaluable images in terms of quality according to radiology review and B) having a complete set of tumor metrics \[MRF (T1 and T2 relaxation values) and QTI (total mean kurtosis MKT, microscopic anisotropy MKA, isotropic heterogeneity MK1, fractional anisotropy FA, microscopic fractional anisotropy µFA)\]
Secondary Outcomes
- MRF T1 Relaxation Value(Day 1)
- MRF T2 Relaxation Value(Day 1)
- QTI Isotropic Heterogeneity MK1(Day 1)
- QTI Microscopic Fractional Anisotropy µFA(Day 1)
- QTI Total Mean Kurtosis(Day 1)
- QTI Fractional Anisotropy FA(Day 1)
- QTI Microscopic Anisotropy MKA(Day 1)
- Median Overall Survival(Up to 4 years)