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Trial record 4 of 5 for:    brigham and women's hospital | Gynecologic Cancer

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03993210
Recruitment Status : Terminated (Key personnel moving out)
First Posted : June 20, 2019
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Clare Tempany, 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.

Condition or disease Intervention/treatment Phase
Gynecologic Tumor Device: MR Fingerprinting Device: QTI 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 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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
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 : November 20, 2019
Actual Study Completion Date : November 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MR Fingerprinting and QTI
  • QTI or MRF will be run along with the routine standard of care MRI.
  • MR Fingerprinting and QTI will not require intravenous contrast agent
Device: MR Fingerprinting
Magnetic Resonance Imaging Machine

Device: QTI
Magnetic Resonance Imaging Machine




Primary Outcome Measures :
  1. T2 relaxation values in gynecological tumors, benign uterine fibroids, and normal anatomic structures [ Time Frame: 2 years ]
    T2 relaxation values (unit: milliseconds) will be extracted from regions-of-interest based on anatomical structures in MR images using MR fingerprinting


Secondary Outcome Measures :
  1. T1 relaxation values in gynecological tumors, benign uterine fibroids, and normal anatomic structures [ Time Frame: 2 years ]
    T1 relaxation values (unit: milliseconds) will be extracted from regions-of-interest based on anatomical structures in MR images using MR fingerprinting

  2. Advanced DWI value (MKi) in gynecological tumors, benign uterine fibroids, and normal anatomic structures [ Time Frame: 2 years ]
    MKi (normalized variance due to isotropic heterogeneity, unitless) will be extracted from regions-of-interest based on anatomical structures in MR images using advanced diffusion weighted sequences

  3. Advanced DWI value (MKa) in gynecological tumors, benign uterine fibroids, and normal anatomic structures [ Time Frame: 2 years ]
    MKa (normalized variance due to anisotropic heterogeneity, unitless) will be extracted from regions-of-interest based on anatomical structures in MR images using advanced diffusion weighted sequences



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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

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
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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
Last Update Posted: November 22, 2019
Last Verified: November 2019
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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Genital Neoplasms, Female
Neoplasms
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Urogenital Neoplasms
Neoplasms by Site
Leiomyoma
Myofibroma
Connective Tissue Diseases