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

Not Applicable

Terminated

Conditions: Gynecologic Tumor

Interventions: Device: Magnetic Resonance Fingerprinting (MRF)
Device: Q-space Trajectory Imaging (QTI)
Device: Magnetic Resonance Imaging Machine (MRI)

Registration Number: NCT03993210

Lead Sponsor: Dana-Farber Cancer Institute

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

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 1

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GYN Cancer Cases	Magnetic Resonance Fingerprinting (MRF)	* Confirmed diagnosis of primary or recurrent gynecological (GYN) malignancies. * Routine clinical standard of care pelvic magnetic resonance imaging (MRI) along with advanced techniques Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) will be performed using a clinical 3T MRI scanner lasting 30-45 minutes with an additional 10-15 minutes for the advanced scans. Per protocol, patient undergoes one scan on visit day 1 and is followed for up to 4 years.
GYN Cancer Cases	Q-space Trajectory Imaging (QTI)	* Confirmed diagnosis of primary or recurrent gynecological (GYN) malignancies. * Routine clinical standard of care pelvic magnetic resonance imaging (MRI) along with advanced techniques Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) will be performed using a clinical 3T MRI scanner lasting 30-45 minutes with an additional 10-15 minutes for the advanced scans. Per protocol, patient undergoes one scan on visit day 1 and is followed for up to 4 years.
GYN Benign Controls	Magnetic Resonance Fingerprinting (MRF)	* Benign gynecological (GYN) fibroids. * Routine clinical standard of care pelvic magnetic resonance imaging (MRI) along with advanced techniques Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) will be performed using a clinical 3T MRI scanner lasting 30-45 minutes with an additional 10-15 minutes for the advanced scans. Per protocol, patient undergoes one scan on visit day 1 and is followed for up to 4 years.
GYN Benign Controls	Magnetic Resonance Imaging Machine (MRI)	* Benign gynecological (GYN) fibroids. * Routine clinical standard of care pelvic magnetic resonance imaging (MRI) along with advanced techniques Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) will be performed using a clinical 3T MRI scanner lasting 30-45 minutes with an additional 10-15 minutes for the advanced scans. Per protocol, patient undergoes one scan on visit day 1 and is followed for up to 4 years.
GYN Cancer Cases	Magnetic Resonance Imaging Machine (MRI)	* Confirmed diagnosis of primary or recurrent gynecological (GYN) malignancies. * Routine clinical standard of care pelvic magnetic resonance imaging (MRI) along with advanced techniques Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) will be performed using a clinical 3T MRI scanner lasting 30-45 minutes with an additional 10-15 minutes for the advanced scans. Per protocol, patient undergoes one scan on visit day 1 and is followed for up to 4 years.
GYN Benign Controls	Q-space Trajectory Imaging (QTI)	* Benign gynecological (GYN) fibroids. * Routine clinical standard of care pelvic magnetic resonance imaging (MRI) along with advanced techniques Magnetic Resonance Fingerprinting (MRF) and Q-space Trajectory Imaging (QTI) will be performed using a clinical 3T MRI scanner lasting 30-45 minutes with an additional 10-15 minutes for the advanced scans. Per protocol, patient undergoes one scan on visit day 1 and is followed for up to 4 years.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Feasible Imaging	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 Outcome Measures

Name	Time	Method
MRF T1 Relaxation Value	Day 1	T1 relaxation values (unit: milliseconds) will be extracted from regions-of-interest based on anatomical structures using MRF.
MRF T2 Relaxation Value	Day 1	T2 relaxation values (unit: milliseconds) will be extracted from regions-of-interest based on anatomical structures in using MRF.
QTI Isotropic Heterogeneity MK1	Day 1	Isotropic heterogeneity MK1 value evaluated by established methods using QTI
QTI Microscopic Fractional Anisotropy µFA	Day 1	Microscopic fractional anisotropy µFA value evaluated by established methods using QTI
QTI Total Mean Kurtosis	Day 1	Total mean kurtosis evaluated by established methods using QTI
QTI Fractional Anisotropy FA	Day 1	Fractional anisotropy FA value evaluated by established methods using QTI
QTI Microscopic Anisotropy MKA	Day 1	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
Median Overall Survival	Up to 4 years	Time from enrollment to death or last follow-up (censored) estimated using Kaplan-Meier methods

Trial Locations

Locations (2): Dana Farber Cancer Institute
🇺🇸
Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States