Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multiparametric MRI for Assessing Breast Cancer Response to Anti-HER2 Therapy

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03738553
Recruitment Status : Enrolling by invitation
First Posted : November 12, 2018
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
Vijayakrishna Gadi, University of Washington

Brief Summary:
This is a single institution, observational research study in which women are observed using DWI/DCE MRI imaging before and after receiving neoadjuvant anti-HER2 therapy.

Condition or disease Intervention/treatment
HER2-positive Breast Cancer Device: MRI Drug: Trastuzumab

Detailed Description:
This is not a treatment trial. Patients will be treated according to the plan developed by their medical oncologists. Only patients planning to receive anti-HER2 therapy as part of planned systemic therapy will be eligible for this imaging study. Patients and their referring oncologist will be asked to start the anti-HER2 therapy 2-3 weeks prior to surgery and after the pre-therapy MRI.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multiparametric MRI for Assessing Breast Cancer Response to Anti-HER2 Therapy
Actual Study Start Date : August 14, 2013
Estimated Primary Completion Date : August 14, 2020
Estimated Study Completion Date : August 14, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab


Intervention Details:
  • Device: MRI
    Diffusion Weighted Imaging and Dynamic Contrast enhanced MRI
  • Drug: Trastuzumab
    Single dose of Trastuzumab prior to surgery


Primary Outcome Measures :
  1. Diffusion sensitization (b value) [ Time Frame: 10 years ]
    Identify optimal b value to maximize conspicuity of cancers in women



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.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sampling Method:   Non-Probability Sample
Study Population
This is not a treatment trial. Patients will be treated according to the plan developed by their medical oncologists. Only patients planning to receive anti-HER2 therapy as part of planned systemic therapy will be eligible for this imaging study. Patients and their referring oncologist will be asked to start the anti-HER2 therapy 2-3 weeks prior to surgery and after the pre-therapy MRI.
Criteria

Inclusion Criteria:

  • Women at least 18 years of age.
  • Have a new diagnosis of invasive breast cancer, clinical stage I - III, HER2 positive.
  • Planning to undergo surgical resection plus adjuvant therapy to include an anti-HER2 agent.
  • Have tissue block available for review of experimental markers.
  • Be a candidate for MRI imaging.
  • Be willing to comply with scheduled visits required for the trial.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Recent therapy for breast cancer prior to baseline MRI.
  • Subjects may not receive other investigational agents during the study window for imaging.
  • Contraindications for MRI or MRI contrast including severe claustrophobia, history of previous reaction to MRI contrast, renal disease, congestive heart failure, other significant systemic diseases or any metal in their body, including but not limited to: a brain aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or defibrillator, cochlear implant, ocular foreign body (e.g. metal shavings), other implanted medical devices: (e.g. Swan Ganz catheter), insulin pump, metal shrapnel or bullet.
  • Pregnant or nursing.

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): NCT03738553


Locations
Layout table for location information
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Sponsors and Collaborators
University of Washington

Layout table for additonal information
Responsible Party: Vijayakrishna Gadi, Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT03738553     History of Changes
Other Study ID Numbers: 7889
First Posted: November 12, 2018    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents