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Abbreviated Breast MRI (AB-MRI) With Golden-angle Radial Compressed-sensing and Parallel Imaging (GRASP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927768
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:

The purpose of this study is to use a magnetic resonance imaging (MRI) sequence called golden-angle radial compressed sensing and parallel imaging (GRASP) as a noninvasive and fast way to measure the wash-in contrast (dye) in the breast. MRI uses a strong magnetic field and radio waves to create images of structures in the body. The goal is to determine if benign and malignant breast lesions have different patterns of contrast wash in.

This study will ask woman planning to undergo a clinical breast MRI with contrast (dye) as part of their standard care.


Condition or disease Intervention/treatment
Breast Cancer Diagnostic Test: Predictive Model Diagnostic Test: Breast Imagers

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Abbreviated Breast MRI (AB-MRI) With Golden-angle Radial Compressed-sensing and Parallel Imaging (GRASP): a Short, Comprehensive Breast MRI Exam Ready for Clinical Prime Time.
Actual Study Start Date : July 31, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
200 women undergoing clinical breast MRI
At time of previously scheduled clinical breast MRI, 60 second postcontrast imaging sequence will be added to the clinical breast MRI. MRI will be interpreted according to usual departmental protocols.
Diagnostic Test: Predictive Model
Anonymized, post-processed MRI imaging data will be analyzed to construct a model predicting benign vs malignant lesions. Model will be tested on a second cohort.

Diagnostic Test: Breast Imagers
Anonymized research sequence with the addition of modeling data (Aims 1A and 1B) will be read by three blinded breast imagers and final evaluation compared to the full protocol.

50 women undergoing clinical breast MRI
At time of previously scheduled clinical breast MRI, 60 second postcontrast imaging sequence will be added to the clinical breast MRI. MRI will be interpreted according to usual departmental protocols.
Diagnostic Test: Predictive Model
Anonymized, post-processed MRI imaging data will be analyzed to construct a model predicting benign vs malignant lesions. Model will be tested on a second cohort.

Diagnostic Test: Breast Imagers
Anonymized research sequence with the addition of modeling data (Aims 1A and 1B) will be read by three blinded breast imagers and final evaluation compared to the full protocol.




Primary Outcome Measures :
  1. To evaluate the diagnostic accuracy of GRASP AB-MRI temporal kinetics in the diagnosis of breast malignancies. [ Time Frame: 12 Months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
250 women scheduled for clinical breast MRI
Criteria

Inclusion Criteria:

  • No contraindications to MRI scanning (pacemaker, implanted metallic objects, severe obesity or other condition that leads to difficulty lying in the magnet)
  • Able and willing to provide informed consent

Exclusion Criteria:

  • Currently undergoing neoadjuvant chemotherapy for breast cancer treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927768


Contacts
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Contact: Laura Heacock (516) 222-2022 Laura.Heacock@nyulangone.org
Contact: Terlika Sood 2122632717 Terlika.Sood@nyulangone.org

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Laura Heacock, MD         
Principal Investigator: Laura Heacock, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Laura Heacock, MD New York Langone Medical Center
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03927768    
Other Study ID Numbers: 18-00684
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: beginning 9 months and ending 36 months following article publication
Access Criteria: Requests may be directed to the PI

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No