Multiparametric MRI as a Non-Invasive Biomarker of the Tumor Microenviroment

Multiparametric MRI as a Non-Invasive Biomarker of the Tumor Microenviroment in Breast Cancer

This study is looking at how an imaging test could help doctors understand if a patient with early breast cancer will respond to drugs that use the patient's immune system to fight cancer.

Study Overview

• Status: Suspended
• Conditions: Breast Cancer; Triple-negative Breast Cancer
• Intervention / Treatment: Other: Tempus assay; Other: Advanced pathology 1; Other: Advanced pathology 2

Detailed Description

Primary Objective:

- To evaluate serial multiparametric MRI as an early marker for tumor immune response to an immune checkpoint inhibitor agent

Secondary Objective:

• To assess the potential of early treatment imaging changes on MRI to discern final tumor treatment response
• To assess the prognostic potential of MRI features

Correlative:

• To correlate MRI features with immunophenotypes (i.e. hot and cold tumors)
• To evaluate the association of MRI features with other known biomarkers of immune checkpoint inhibitor response

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women and men at least 18 years of age that have a new diagnosis of invasive breast cancer with clinical stage I - III disease or regional stage IV with metastasis to the supraclavicular nodes only.

Description

Inclusion Criteria:

Women and men at least 18 years of age.

• Have a new diagnosis of invasive breast cancer with clinical stage I - III disease or regional stage IV with metastasis to the supraclavicular nodes only
• Hormone receptor negative (estrogen-receptor < 5% and/or progesterone-receptor < 5%)
• Human epidermal growth factor receptor 2 (HER2) negative by immunohistochemistry or fluorescence in situ hybridization (FISH)
• Enrollment in a neoadjuvant clinical trial that includes the evaluation of immunotherapy as a part of the regimen; patient must be randomized to a treatment arm (including the control arm) prior to enrolling in this study
• Planning to undergo surgical resection and subsequent adjuvant therapy as per the treatment clinical trial or the clinical provider
• Have tissue available for additional correlative studies OR planned to undergo an additional pre-treatment biopsy for additional tissue acquisition as per provider or the treatment clinical trial
• 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:

Systemic or locoregional treatment for the current episode of breast cancer prior to baseline breast MRI.

• Poor visualization of the tumor on the initial breast MRI (investigator discretion)
• Pregnant or nursing.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Advanced Pathology; Breast magnetic resonance imaging (MRI) as a preliminary predictive biomarker for breast cancer treatment response.	Other: Tempus assay; Blood collection; Other: Advanced pathology 1; Tissue procurement (from diagnostic biopsy); Other: Advanced pathology 2; Tissue procurement (from research biopsy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlate dynamic-contrast enhanced MRI characteristics	Baseline up to about 14 weeks
Correlate diffusion weight imaging MRI characteristics	Baseline up to about 14 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluate association between MRI features and pathologic response	Baseline up to about 14 weeks
Evaluate association between MRI features and recurrence-free survival	Baseline up to about 14 weeks

Collaborators and Investigators

• Sponsor: Laura Kennedy
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Laura Kennedy, MD, PhD, Vanderbilt Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2021
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: March 12, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Actual): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antioxidants; Protective Agents; TEMPO
• Other Study ID Numbers: VICC BRE 20104; P50CA098131 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No