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

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.

Study Overview

• Status: Terminated
• Conditions: Gynecologic Tumor
• Intervention / Treatment: Device: Magnetic Resonance Fingerprinting (MRF); Device: Q-space Trajectory Imaging (QTI); Device: Magnetic Resonance Imaging Machine (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

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: GYN Cancer Cases; 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); In MRF, multiple tissue properties are acquired simultaneously.; Device: Q-space Trajectory Imaging (QTI); 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.; Device: Magnetic Resonance Imaging Machine (MRI); 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.
ACTIVE_COMPARATOR: GYN Benign Controls; 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); In MRF, multiple tissue properties are acquired simultaneously.; Device: Q-space Trajectory Imaging (QTI); 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.; Device: Magnetic Resonance Imaging Machine (MRI); 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Clare Tempany, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 18, 2019
• Primary Completion (ACTUAL): September 19, 2019
• Study Completion (ACTUAL): September 19, 2019

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: June 18, 2019
• First Posted (ACTUAL): June 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Gynecologic Tumor
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Genital Neoplasms, Female; Leiomyoma; Myofibroma
• Other Study ID Numbers: 19-056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication.
• IPD Sharing Access Criteria: BCH - Contact the Technology & Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No