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

NCT ID: NCT03993210

Last Updated: 2020-12-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-18
• Study Completion Date: 2019-09-19

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.

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

Conditions

Gynecologic Tumor

Keywords

Gynecologic Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Magnetic Resonance Fingerprinting (MRF)

Intervention Type: DEVICE

In MRF, multiple tissue properties are acquired simultaneously.

Q-space Trajectory Imaging (QTI)

Intervention Type: 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.

Magnetic Resonance Imaging Machine (MRI)

Intervention Type: 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

• 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.

Group Type: ACTIVE_COMPARATOR

Magnetic Resonance Fingerprinting (MRF)

Intervention Type: DEVICE

In MRF, multiple tissue properties are acquired simultaneously.

Q-space Trajectory Imaging (QTI)

Intervention Type: 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.

Magnetic Resonance Imaging Machine (MRI)

Intervention Type: 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.

Interventions

Magnetic Resonance Fingerprinting (MRF)

In MRF, multiple tissue properties are acquired simultaneously.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Clare Tempany

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Clare Tempany, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

19-056

Identifier Type: -

Identifier Source: org_study_id