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

Gynecologic Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03993210
• Other study ID #: 19-056
• Status: Terminated
• Phase: N/A
• Start date: September 18, 2019
• Est. completion date: September 19, 2019

Study information

• Verified date: November 2020
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 19, 2019
• Est. primary completion date: September 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Genital Neoplasms, Female
• Gynecologic Tumor
• Leiomyoma

Intervention

Device:
• Magnetic Resonance Fingerprinting (MRF)
In MRF, multiple tissue properties are acquired simultaneously.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	MRF T1 Relaxation Value	T1 relaxation values (unit: milliseconds) will be extracted from regions-of-interest based on anatomical structures using MRF.	Day 1
Secondary	MRF T2 Relaxation Value	T2 relaxation values (unit: milliseconds) will be extracted from regions-of-interest based on anatomical structures in using MRF.	Day 1
Secondary	QTI Total Mean Kurtosis	Total mean kurtosis evaluated by established methods using QTI	Day 1
Secondary	QTI Microscopic Anisotropy MKA	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	Day 1
Secondary	QTI Isotropic Heterogeneity MK1	Isotropic heterogeneity MK1 value evaluated by established methods using QTI	Day 1
Secondary	QTI Fractional Anisotropy FA	Fractional anisotropy FA value evaluated by established methods using QTI	Day 1
Secondary	QTI Microscopic Fractional Anisotropy µFA	Microscopic fractional anisotropy µFA value evaluated by established methods using QTI	Day 1
Secondary	Median Overall Survival	Time from enrollment to death or last follow-up (censored) estimated using Kaplan-Meier methods	Up to 4 years