Clinical trial · Observational
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
NCT04803084CI-TRIAL-00122752suspendedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): MRI upgrade
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Triple-negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Advanced pathology 1 | Other | — | UNRESOLVED |
| Advanced pathology 2 | Other | — | UNRESOLVED |
| Tempus assay | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Advanced Pathology
- description
- Breast magnetic resonance imaging (MRI) as a preliminary predictive biomarker for breast cancer treatment response.
- interventionNames
- Other: Tempus assay
- Other: Advanced pathology 1
- Other: Advanced pathology 2
Primary outcomes (2)
- measure
- Correlate dynamic-contrast enhanced MRI characteristics
- timeFrame
- Baseline up to about 14 weeks
- measure
- Correlate diffusion weight imaging MRI characteristics
- timeFrame
- Baseline up to about 14 weeks
Secondary outcomes (2)
- measure
- Evaluate association between MRI features and pathologic response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.