The Value of Advanced MR Imaging in Gynecological Tumors and Benign Uterine Fibroids

Dana-Farber Cancer Institute1 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Gynecologic Tumor

Interventions

Magnetic Resonance Fingerprinting (MRF)DEVICE

In MRF, multiple tissue properties are acquired simultaneously.

Q-space Trajectory Imaging (QTI)DEVICE

By using q-space trajectory encoding and a diffusion tensor distribution model, QTI improves the discrimination of diffusivity, shape, and orientation of diffusion microenvironments and therefore carries major potential for imaging the tumor microenvironment.

Magnetic Resonance Imaging Machine (MRI)DEVICE

MRI is routinely used in gynecologic malignancies for its ability to depict the extent of disease at diagnosis providing guidance in staging and treatment planning.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Number of Patients With Feasible Imaging

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 \[MRF (T1 and T2 relaxation values) and QTI (total mean kurtosis MKT, microscopic anisotropy MKA, isotropic heterogeneity MK1, fractional anisotropy FA, microscopic fractional anisotropy µFA)\]

Time frame: Day 1

Secondary Outcomes

MRF T1 Relaxation Value

T1 relaxation values (unit: milliseconds) will be extracted from regions-of-interest based on anatomical structures using MRF.

Time frame: Day 1

MRF T2 Relaxation Value

T2 relaxation values (unit: milliseconds) will be extracted from regions-of-interest based on anatomical structures in using MRF.

Time frame: Day 1

QTI Total Mean Kurtosis

Total mean kurtosis evaluated by established methods using QTI

Time frame: Day 1

QTI Microscopic Anisotropy MKA

MKa (normalized variance due to anisotropic heterogeneity, unitless) will be extracted from regions-of-interest based on anatomical structures in using advanced diffusion weighted sequences with QTI

Time frame: Day 1

QTI Isotropic Heterogeneity MK1

Isotropic heterogeneity MK1 value evaluated by established methods using QTI

Time frame: Day 1

QTI Fractional Anisotropy FA

Fractional anisotropy FA value evaluated by established methods using QTI

Data from ClinicalTrials.gov

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