Quantitative MRI Assessment of Breast Cancer Therapy Response

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Corewell Health East
Study ID
NCT05704062
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Diffusion Weighted Imaging — PROCEDURE
    Undergo DW-MRI
  • Dynamic Contrast-Enhanced Magnetic Resonance Imaging — PROCEDURE
    Undergo DCE-MRI

Study Details

The goal of this observational study is to investigate and validate multi-parametric magnetic resonance imaging (MRI) modalities for assessment of breast cancer response to neoadjuvant chemotherapy in a multi-site and multi-MRI scanner platform setting. This study is conducted at Oregon Health \& Science University (OHSU), University of Washington (UW), and University of Iowa (UI) using Siemens, Philips, and General Electric MRI scanners, respectively. MRI is a type of scan that uses a very strong magnet and no radiation to take very detailed pictures of parts of the body. MRI is often used as standard of care to take pictures of breast tumor(s) before and after chemotherapy treatment in order to measure the tumor size changes in response to treatment, and in order to plan for surgery. MRI is used because the images it takes are very clear and the borders of the tumor can be measured very accurately. However the tumor size alone is often not a good early indicator of whether or not the tumor responds to treatment. Tumor size change usually happens late during the period of treatment, and tumor size measured with MRI after treatment can overestimate or underestimate the residual cancer. This makes it difficult to do the right surgical planning. In addition to measuring tumor size, the MRI scans in this research study will also measure changes in tumor blood vessels and the number of cancer cells per unit of tumor volume. The purpose of this study is to see whether MRI measurements of these functional tumor properties provide better early prediction and evaluation of breast cancer response to neoadjuvant chemotherapy than tumor size measurement. This is an observational study because the MRI procedures are not expected to have an effect on health outcomes. Eligible participants on this study are receiving standard of care neoadjuvant treatment for their cancer.

Key Dates

Start date
Mar 18, 2010
Status verified
Jan 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
135 participants (estimated)

Arms

  • Arm: Diagnostic (multi-parametric MRI)
    Patients undergo an MRI exam that includes standard anatomic scans, DCE-MRI, and DW-MRI at baseline, after first treatment cycle, at mid-point of treatment course, and after completion of neoadjuvant chemotherapy.

Primary Outcome Measure

Compare functional MRI biomarkers with tumor size measurement for early prediction of breast cancer response to neoadjuvant chemotherapy [ Time Frame: Through study completion, up to 5 years ]

Central Contacts

  • Wei Huang, Chief, MR Rad Imaging Physics, PhD
    248-551-6468
    [email protected]
  • Kristen Grant, RN
    248-551-0439

Locations (4)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242
Courtney Wille
319-678-2718
James Holmes, Ph.D.
[email protected]
James Holmes, Ph.D. (PRINCIPAL_INVESTIGATOR)
Corewell Health William Beaumont University HospitalRoyal OakMichigan48073
Wei Huang, Ph.D.
[email protected]
248-551-6468
Wei Huang, Ph.D. (PRINCIPAL_INVESTIGATOR)
OHSU Knight Cancer InstitutePortlandOregon97239-
University of WashingtonSeattleWashington98109
Savannah Partridge, Ph.D.
[email protected]
206-606-1306
Savannah Partridge, Ph.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Iowa City, IA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Iowa· Iowa City, IACorewell Health William Beaumont University Hospital· Royal Oak, MIOHSU Knight Cancer Institute· Portland, ORUniversity of Washington· Seattle, WA

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