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

NCT03993210 | Terminated Results DMC FDA Device

• 1 other identifier: 19-056
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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.

Conditions

Gynecologic Tumor

Keywords

Gynecologic Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• MRF T1 Relaxation Value

  Day 1

• MRF T2 Relaxation Value

  Day 1

• QTI Total Mean Kurtosis

  Day 1

• QTI Microscopic Anisotropy MKA

  Day 1

• QTI Isotropic Heterogeneity MK1

  Day 1

Study Arms (2)

GYN Cancer Cases

EXPERIMENTAL

* 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); Device: Q-space Trajectory Imaging (QTI); Device: Magnetic Resonance Imaging Machine (MRI)

GYN Benign Controls

ACTIVE COMPARATOR

* 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); Device: Q-space Trajectory Imaging (QTI); Device: Magnetic Resonance Imaging Machine (MRI)

Interventions

Magnetic Resonance Fingerprinting (MRF) DEVICE

In MRF, multiple tissue properties are acquired simultaneously.

GYN Benign Controls; GYN Cancer Cases

Q-space Trajectory Imaging (QTI) DEVICE

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.

GYN Benign Controls; GYN Cancer Cases

Magnetic Resonance Imaging Machine (MRI) DEVICE

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.

GYN Benign Controls; GYN Cancer Cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Genital Neoplasms, Female

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Limitations and Caveats

The study was closed when the Principal Investigator left the country to begin work in Finland. One subject was scanned, but never analyzed.

Results Point of Contact

• Title: Clare Tempany
• Organization: DFCI

ctempany@bwh.harvard.edu

617-732-7858

Study Officials

• Clare Tempany, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: June 20, 2019
• Study Start: September 18, 2019
• Primary Completion: September 19, 2019
• Study Completion: September 19, 2019
• Last Updated: December 2, 2020
• Results First Posted: December 2, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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

Locations

US (2)