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

NCT04803084 | Suspended

• 2 other identifiers: VICC BRE 20104P50CA098131
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Triple-negative Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (1)

Advanced Pathology

Breast magnetic resonance imaging (MRI) as a preliminary predictive biomarker for breast cancer treatment response.

Other: Tempus assay; Other: Advanced pathology 1; Other: Advanced pathology 2

Interventions

Tempus assay OTHER

Blood collection

Advanced Pathology

Advanced pathology 1 OTHER

Tissue procurement (from diagnostic biopsy)

Advanced Pathology

Advanced pathology 2 OTHER

Tissue procurement (from research biopsy)

Advanced Pathology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laura Kennedy: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Laura Kennedy, MD, PhD

  Vanderbilt Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 17, 2021
• Study Start: August 9, 2021
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

US (1)