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

Primary Purpose

Gynecologic Tumor

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Magnetic Resonance Fingerprinting (MRF)

Q-space Trajectory Imaging (QTI)

Magnetic Resonance Imaging Machine (MRI)

About this trial

This is an interventional diagnostic trial for Gynecologic Tumor focused on measuring Gynecologic Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Brigham and Women's Hospital
Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GYN Cancer Cases

GYN Benign Controls

Arm 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.

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.

Outcomes

Primary Outcome Measures

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)]

Secondary Outcome Measures

MRF T1 Relaxation Value

T1 relaxation values (unit: milliseconds) will be extracted from regions-of-interest based on anatomical structures using MRF.

MRF T2 Relaxation Value

T2 relaxation values (unit: milliseconds) will be extracted from regions-of-interest based on anatomical structures in using MRF.

QTI Total Mean Kurtosis

Total mean kurtosis evaluated by established methods using QTI

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

QTI Isotropic Heterogeneity MK1

Isotropic heterogeneity MK1 value evaluated by established methods using QTI

QTI Fractional Anisotropy FA

Fractional anisotropy FA value evaluated by established methods using QTI

QTI Microscopic Fractional Anisotropy µFA

Microscopic fractional anisotropy µFA value evaluated by established methods using QTI

Median Overall Survival

Time from enrollment to death or last follow-up (censored) estimated using Kaplan-Meier methods

Full Information

NCT ID

NCT03993210

First Posted

May 22, 2019

Last Updated

November 9, 2020

Sponsor

Dana-Farber Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT03993210

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Terminated

Why Stopped

Key personnel moving out

Study Start Date

September 18, 2019 (Actual)

Primary Completion Date

September 19, 2019 (Actual)

Study Completion Date

September 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gynecologic Tumor

Keywords

Gynecologic Tumor

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GYN Cancer Cases

Arm Type

Experimental

Arm Description

Arm Title

GYN Benign Controls

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Magnetic Resonance Fingerprinting (MRF)

Intervention Description

In MRF, multiple tissue properties are acquired simultaneously.

Intervention Type

Device

Intervention Name(s)

Q-space Trajectory Imaging (QTI)

Intervention Description

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

Intervention Name(s)

Magnetic Resonance Imaging Machine (MRI)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Patients With Feasible Imaging

Description

Time Frame

Day 1

Secondary Outcome Measure Information:

Title

MRF T1 Relaxation Value

Description

T1 relaxation values (unit: milliseconds) will be extracted from regions-of-interest based on anatomical structures using MRF.

Time Frame

Day 1

Title

MRF T2 Relaxation Value

Description

T2 relaxation values (unit: milliseconds) will be extracted from regions-of-interest based on anatomical structures in using MRF.

Time Frame

Day 1

Title

QTI Total Mean Kurtosis

Description

Total mean kurtosis evaluated by established methods using QTI

Time Frame

Day 1

Title

QTI Microscopic Anisotropy MKA

Description

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

Time Frame

Day 1

Title

QTI Isotropic Heterogeneity MK1

Description

Isotropic heterogeneity MK1 value evaluated by established methods using QTI

Time Frame

Day 1

Title

QTI Fractional Anisotropy FA

Description

Fractional anisotropy FA value evaluated by established methods using QTI

Time Frame

Day 1

Title

QTI Microscopic Fractional Anisotropy µFA

Description

Microscopic fractional anisotropy µFA value evaluated by established methods using QTI

Time Frame

Day 1

Title

Median Overall Survival

Description

Time from enrollment to death or last follow-up (censored) estimated using Kaplan-Meier methods

Time Frame

Up to 4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clare Tempany, MD

Organizational Affiliation

Brigham and Women's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication.

IPD Sharing 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

Learn more about this trial

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

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