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

Dana-Farber Cancer Institute

Status: Terminated

Conditions: Gynecologic Tumor

Treatments: Device: Magnetic Resonance Fingerprinting (MRF); Device: Magnetic Resonance Imaging Machine (MRI); Device: Q-space Trajectory Imaging (QTI)

Study type: Interventional

Funder types: Other

Identifiers

NCT03993210

19-056

Details and patient eligibility

About

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.

Full 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

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

GYN Cancer Cases

Experimental group

Description:

* 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.

Treatment:

Device: Magnetic Resonance Fingerprinting (MRF)

Device: Q-space Trajectory Imaging (QTI)

Device: Magnetic Resonance Imaging Machine (MRI)

GYN Benign Controls

Active Comparator group

Description:

* 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.

Treatment:

Device: Magnetic Resonance Fingerprinting (MRF)

Device: Q-space Trajectory Imaging (QTI)

Device: Magnetic Resonance Imaging Machine (MRI)