Clinical trial · Observational
Radiomic Markers for Breast Cancer Metastasis and Treatment Response Using MRI
Radiomic Markers for Breast Cancer Metastasis Using Dynamic Contrast Enhanced MRI and Diffusion-Weighted MRI
NCT03709186CI-TRIAL-00065509completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary aim of the study is to identify radiomic features as biomarkers of metastatic progression following primary therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Pathologic complete response (pCR)
- timeFrame
- Up to 60 months
- description
- Evaluating the degree of absence of residual cancer cells
Secondary outcomes (3)
- measure
- Time to distant breast cancer recurrence (months)
- timeFrame
- Up to 60 months
- description
- Evaluating the time until a recurrence event has occurred in the breast.
- measure
- Time to distant metastasis
- timeFrame
- Up to 60 months
- description
- Evaluating onset of distant metastasis
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects must give appropriate written informed consent prior to participation in the study; 2. Subjects must be able and willing to comply with the safety procedures during the scanning period; 3. Subjects must be men and women age 18+ 4. Biopsy-confirmed diagnosis of invasive breast cancer; (ER+/-, PR+/-, HER2+/-). 5. Stage I-III disease according to the AJCC v7 criteria. 6. Patients with sufficient renal function (creatinine clearance, i.e., \>=30 mL/min/1.73 m2). 7. Primary treatments can include neoadjuvant chemotherapy or surgery Exclusion Criteria: * 1\. Subjects with a past medical history of abnormalities, significant injury, or medical or surgical procedures (e.g. Silicone/saline implants) involving either breast, exclusive of the lesion at issue. 2\. Subjects with any dermatologic abnormalities (including tattoos, open sores, or breached skin) involving either breast 3. Subjects with a current or past medical history of connective tissue disease 4. Subjects who are pregnant or lactating 5. Subjects with an implanted electronic device such as a cardiac pacemaker, defibrillator, or neurological stimulator 6. Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study, such as significant anxiety, history of musculoskeletal disease which may predispose them to discomfort during the imaging/scanning period. 7\. Allergies to any contrast agent administered to this study.
References
Publications (0)
Data not yet available
No reference posted for this study.