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

  • STATUS
    Recruiting
  • End date
    Nov 19, 2023
  • participants needed
    10
  • sponsor
    Laura Kennedy
Updated on 19 April 2022
estrogen
growth factor
progesterone
metastasis
immunohistochemistry
epidermal growth factor receptor
HER2
EGFR
erbb2
epidermal growth factor
invasive breast cancer

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

Details
Condition Breast Cancer, Triple-negative Breast Cancer
Treatment Tempus assay, Advanced pathology 1, Advanced pathology 2
Clinical Study IdentifierNCT04803084
SponsorLaura Kennedy
Last Modified on19 April 2022

Eligibility

Yes No Not Sure

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
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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