Clinical trial NCT03993210: The Value of Advanced MR Imaging in Gynecological Tumors and Benign Uterine Fibroids
Official title: The Value of Advanced MR Imaging in Gynecological Tumors and Benign Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gynecologic Tumor
Keywords: Gynecologic Tumor
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: Number of Patients With Feasible Imaging
timeFrame: Day 1
Secondary outcomes:
measure: MRF T1 Relaxation Value
timeFrame: Day 1
measure: MRF T2 Relaxation Value
timeFrame: Day 1
measure: QTI Total Mean Kurtosis
timeFrame: Day 1
measure: QTI Microscopic Anisotropy MKA
timeFrame: Day 1
measure: QTI Isotropic Heterogeneity MK1
timeFrame: Day 1
measure: QTI Fractional Anisotropy FA
timeFrame: Day 1
measure: QTI Microscopic Fractional Anisotropy µFA
timeFrame: Day 1
measure: Median Overall Survival
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Clare Tempany, MD
role: PRINCIPAL_INVESTIGATOR
References: