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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04803084
• Other study ID #: VICC BRE 20104
• Secondary ID: P50CA098131
• Status: Suspended
• Start date: August 9, 2021
• Est. completion date: August 2025

Study information

• Verified date: December 2023
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 10
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Triple Negative Breast Neoplasms
• Triple-negative Breast Cancer

Intervention

Other:
• Tempus assay
Blood collection
• Advanced pathology 1
Tissue procurement (from diagnostic biopsy)
• Advanced pathology 2
Tissue procurement (from research biopsy)

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Laura Kennedy	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlate dynamic-contrast enhanced MRI characteristics		Baseline up to about 14 weeks
Primary	Correlate diffusion weight imaging MRI characteristics		Baseline up to about 14 weeks
Secondary	Evaluate association between MRI features and pathologic response		Baseline up to about 14 weeks
Secondary	Evaluate association between MRI features and recurrence-free survival		Baseline up to about 14 weeks