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Low-field MRI for Breast Cancer Screening

Primary Purpose

Breast Benign, Malignant Neoplasm of Breast, Breast Malignant Tumor

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Magnetic Resonance Imaging (MRI)

About this trial

This is an interventional diagnostic trial for Breast Benign focused on measuring Breast pathologies benign, Breast pathologies malignant

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Informed consent will be obtained from the adult volunteer subjects by the principal investigator, the coinvestigators, or the study staff prior to the imaging session. The investigator obtaining consent will explain in detail the protocol of the study, its purpose, and potential benefits to the society.
Subjects will be informed about the minimal risks of ultra-low magnetic fields) and of low-frequency nonionizing RF radiation involved in ultra-low field MR imaging. Subjects will also be informed about small space within the magnet. Unlike high-field scanners, there is essentially no sound produced by the imaging gradients, so hearing protection is not required.
Subjects will be informed that if they feel uncomfortable with the study, they can choose to terminate the study at any time. They will be informed that their refusal to participate in the study or choosing to terminate it at some point will have no effect on care and treatment received by them at MGH now or in future.
The subjects will be informed that their personal information will be protected as per the HIPAA guidelines.
The subjects will have at least 15 minutes to consider participation.
Subjects will undergo MR contraindication screening to ensure that they meet the basic inclusion/exclusion criteria for the study and give written informed consent immediately prior to the MR imaging study.
Recruit adult female volunteers of any race or ethnic background, between the ages of 20 to 80, who are either scheduled for breast imaging and/or a percutaneous biopsy.
All efforts will be taken to find interpreters for volunteers who do not understand English, enabling them to be screened and consented with the short-form consent form so that they may participate in this study.

Exclusion Criteria:

Exclusion criteria include MR contraindications
Electronic implants such as cardiac pacemakers or perfusion pumps
Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
Ferromagnetic objects such as jewelry or metal clips in clothing
Pregnant or breast feeding women
A history of uncontrolled seizures
Claustrophobia
Any greater than normal potential for cardiac arrest
Subjects less than 18 years of age or over 80 years of age.

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

BREAST MRI IMAGES FROM HEALTHY VOLUNTEERS

BREAST MRI IMAGES FROM PERSONS WITH KNOWN BREAST PATHOLOGIES BENIGN AND MALIGNANT

Arm Description

All participants will be recruited prior to their scheduled diagnostic imaging or diagnostic procedures. The expected time to complete the study is a maximum of 1.5 hours with approximately 30-60 minutes of scan time, depending on the specific MRI software being tested.

Outcomes

Primary Outcome Measures

T1rho dispersion signal

Student's t-test to compare T1rho dispersion: a) in all participants between fat and fibroglandular tissues (expected difference); b) in patients between fat and cancer tissues (expected difference); and c) in patients between fibroglandular and cancer tissues (expected difference in dispersion curve).

Secondary Outcome Measures

Full Information

NCT ID

NCT05486520

First Posted

August 1, 2022

Last Updated

September 18, 2023

Sponsor

Massachusetts General Hospital

Collaborators

National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT05486520

Brief Title

Low-field MRI for Breast Cancer Screening

Official Title

A New Breast Cancer MRI Biomarker Using the Intrinsic T1rho Signal

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

September 1, 2022 (Actual)

Primary Completion Date

October 15, 2023 (Anticipated)

Study Completion Date

September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

National Institutes of Health (NIH)

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.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

This research study wants to learn more about improving the attainable image quality for ultra-low field MRI of the breast using new data acquisition methods(also called MRI pulse sequences) and image reconstruction algorithms. For this pilot study, are testing a new method to image breast cancers at ultra-low magnetic field. The findings from this breast imaging technique will be compared with results obtained from standard mammograms, ultrasounds, MRIs, clinical examinations, and pathology evaluations, when available. The ultra-low field breast MRI performed for this study will be for research purposes and will not be used to guide clinical care.

Detailed Description

This research study is a Feasibility Study, which is the first-time investigators are examining the use of ultra-low field MRI to image breast cancer. The purpose of the study is to develop, test and improve new software techniques for our magnetic resonance imaging (MRI) systems. In developing new, ultra-low field MRI scanners develop sequences and other software algorithms from time to time. This study will enroll both healthy participants and persons with breast cancer. This investigation will also compare these images to standard mammograms, ultrasounds, MRIs, clinical examinations, and pathology evaluations when available. It is expected that about 40 people will take part in this research study.

6. Conditions and Keywords

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

Breast Benign, Malignant Neoplasm of Breast, Breast Malignant Tumor

Keywords

Breast pathologies benign, Breast pathologies malignant

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BREAST MRI IMAGES FROM HEALTHY VOLUNTEERS

Arm Type

Active Comparator

Arm Description

Arm Title

BREAST MRI IMAGES FROM PERSONS WITH KNOWN BREAST PATHOLOGIES BENIGN AND MALIGNANT

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Magnetic Resonance Imaging (MRI)

Intervention Description

MR images will be acquired using an ultra-low magnetic field 6.5 mT scanner located at the Martinos Center. The study time is estimated to be a maximum of 90 minutes with a maximum of 60 minutes of imaging time

Primary Outcome Measure Information:

Title

T1rho dispersion signal

Description

Time Frame

1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Informed consent will be obtained from the adult volunteer subjects by the principal investigator, the coinvestigators, or the study staff prior to the imaging session. The investigator obtaining consent will explain in detail the protocol of the study, its purpose, and potential benefits to the society. Subjects will be informed about the minimal risks of ultra-low magnetic fields) and of low-frequency nonionizing RF radiation involved in ultra-low field MR imaging. Subjects will also be informed about small space within the magnet. Unlike high-field scanners, there is essentially no sound produced by the imaging gradients, so hearing protection is not required. Subjects will be informed that if they feel uncomfortable with the study, they can choose to terminate the study at any time. They will be informed that their refusal to participate in the study or choosing to terminate it at some point will have no effect on care and treatment received by them at MGH now or in future. The subjects will be informed that their personal information will be protected as per the HIPAA guidelines. The subjects will have at least 15 minutes to consider participation. Subjects will undergo MR contraindication screening to ensure that they meet the basic inclusion/exclusion criteria for the study and give written informed consent immediately prior to the MR imaging study. Recruit adult female volunteers of any race or ethnic background, between the ages of 20 to 80, who are either scheduled for breast imaging and/or a percutaneous biopsy. All efforts will be taken to find interpreters for volunteers who do not understand English, enabling them to be screened and consented with the short-form consent form so that they may participate in this study. Exclusion Criteria: Exclusion criteria include MR contraindications Electronic implants such as cardiac pacemakers or perfusion pumps Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants Ferromagnetic objects such as jewelry or metal clips in clothing Pregnant or breast feeding women A history of uncontrolled seizures Claustrophobia Any greater than normal potential for cardiac arrest Subjects less than 18 years of age or over 80 years of age.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthew S Rosen, Ph.D

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

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 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

MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

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Low-field MRI for Breast Cancer Screening

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