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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Gynecologic Tumor

Intervention / Treatment
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* Device: Magnetic Resonance Fingerprinting (MRF)
* Device: Q-space Trajectory Imaging (QTI)
* Device: Magnetic Resonance Imaging Machine (MRI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GYN Cancer Cases<br>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. | Device: Magnetic Resonance Fingerprinting (MRF)<br>* In MRF, multiple tissue properties are acquired simultaneously.<br>Device: Q-space Trajectory Imaging (QTI)<br>* 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.<br>Device: Magnetic Resonance Imaging Machine (MRI)<br>* 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.<br>|
| Active Comparator: GYN Benign Controls<br>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. | Device: Magnetic Resonance Fingerprinting (MRF)<br>* In MRF, multiple tissue properties are acquired simultaneously.<br>Device: Q-space Trajectory Imaging (QTI)<br>* 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.<br>Device: Magnetic Resonance Imaging Machine (MRI)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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)] | Day 1 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gynecologic Tumor