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

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ClinicalTrials.gov Identifier: NCT03993210
Recruitment Status : Terminated (Key personnel moving out)
First Posted : June 20, 2019
Results First Posted : December 2, 2020
Last Update Posted : December 2, 2020
Sponsor:
Information provided by (Responsible Party):
Clare Tempany, Dana-Farber Cancer Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gynecologic Tumor Device: Magnetic Resonance Fingerprinting (MRF) Device: Q-space Trajectory Imaging (QTI) Device: Magnetic Resonance Imaging Machine (MRI) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Value of Advanced MR Imaging in Gynecological Tumors and Benign Uterine Fibroids
Actual Study Start Date : September 18, 2019
Actual Primary Completion Date : September 19, 2019
Actual Study Completion Date : September 19, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Patients With Feasible Imaging [ Time Frame: 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 :
  1. MRF T1 Relaxation Value [ Time Frame: Day 1 ]
    T1 relaxation values (unit: milliseconds) will be extracted from regions-of-interest based on anatomical structures using MRF.

  2. MRF T2 Relaxation Value [ Time Frame: Day 1 ]
    T2 relaxation values (unit: milliseconds) will be extracted from regions-of-interest based on anatomical structures in using MRF.

  3. QTI Total Mean Kurtosis [ Time Frame: Day 1 ]
    Total mean kurtosis evaluated by established methods using QTI

  4. QTI Microscopic Anisotropy MKA [ Time Frame: 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

  5. QTI Isotropic Heterogeneity MK1 [ Time Frame: Day 1 ]
    Isotropic heterogeneity MK1 value evaluated by established methods using QTI

  6. QTI Fractional Anisotropy FA [ Time Frame: Day 1 ]
    Fractional anisotropy FA value evaluated by established methods using QTI

  7. QTI Microscopic Fractional Anisotropy µFA [ Time Frame: Day 1 ]
    Microscopic fractional anisotropy µFA value evaluated by established methods using QTI

  8. Median Overall Survival [ Time Frame: Up to 4 years ]
    Time from enrollment to death or last follow-up (censored) estimated using Kaplan-Meier methods


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03993210


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Clare Tempany, MD Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Clare Tempany, Dana-Farber Cancer Institute:
Informed Consent Form  [PDF] April 19, 2020
Study Protocol and Statistical Analysis Plan  [PDF] October 2, 2017

More Information
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Responsible Party: Clare Tempany, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03993210    
Other Study ID Numbers: 19-056
First Posted: June 20, 2019    Key Record Dates
Results First Posted: December 2, 2020
Last Update Posted: December 2, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data can be shared no earlier than 1 year following the date of publication.
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

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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
Keywords provided by Clare Tempany, Dana-Farber Cancer Institute:
Gynecologic Tumor
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Genital Neoplasms, Female
Neoplasms
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
 Connective Tissue Diseases
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases