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Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.

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

Clinicaltrials.gov identifier NCT03927768

Recruitment Status Recruiting

First Posted April 25, 2019

Last update posted July 28, 2020

Study Description

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:Breast Cancer
  • Intervention/Treatment: Diagnostic Test: Predictive Model
    Diagnostic Test: Breast Imagers
  • Phase: N/A
Detailed Description

N/A

Study Design
  • 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 2018
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: December 2020
Groups and Cohorts
Groups/Cohorts 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.
Outcome Measures
  • 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 ]
Eligibility Criteria
  • Ages Eligible for Study: 18 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.

Contacts and Locations
Contacts

Contact: Laura Heacock (516) 222-2022 Laura.Heacock@nyulangone.org

Contact: Terlika Sood 2122632717 Terlika.Sood@nyulangone.org

Locations

United States, New York
NYU Langone Health
New York

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Laura Heacock, MD New York Langone Medical Center

More Information
  • Responsible Party: NYU Langone Health
  • ClinicalTrials.gov Identifier: NCT03927768 History of Changes
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No