Clinical trial · Interventional
Role of Magnetic Resonance Fingerprinting and Quantitative MR Imaging in Breast Cancer
Role of Magnetic Resonance Fingerprinting and Quantitative MR Imaging in Assessment of Response to Neo-Adjuvant Chemotherapy in Breast Cancer
NCT03650803CI-TRIAL-00078072completedN/AResults postedClinicalTrials.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 purpose of this study is to determine if new methods of MRI imaging can better measure participants' response to chemotherapy treatment.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D MR Fingerprinting scan | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 3D MR Fingerprinting scan
- description
- Three separate 3D MR fingerprinting scans: Before the start of chemotherapy, 7-10 days after the first cycle of chemotherapy, and within 1 month of the end of chemotherapy treatment.
- interventionNames
- Device: 3D MR Fingerprinting scan
Primary outcomes (2)
- measure
- Utility of Percentage Change in Longitudinal (T1) and Transverse (T2) Relaxation Times From Baseline to First Cycle of Treatment in Assessment of Response to Neo-adjuvant Chemotherapy in Breast Cancer.
- timeFrame
- 2 years from start of study
- description
- For each patient the first MRF scan was performed at the baseline before chemotherapy and the second MRF scan was performed 7-10 days after the first cycle of chemotherapy. Quantitative T1 and T2 relaxation times measured using MRF were used to characterize the breast lesions and predict the treatment response at an early phase (7-10 days after one-cycle of neoadjuvant chemotherapy). Changes in relaxation times (T1 or T2) between the baseline and 7-10 days after the first cycle of chemotherapy were used for predicting the early prediction of treatment response. Both T1 and T2 relaxation times were measured in the unit of millisecond. The unit of the measurement for this primary outcome was percentage changes of relaxation times (T1 or T2) obtained at the two different time points. The pathological results obtained after the breast surgery were used as the ground truth to determine patients response to the treatment and correlated with the findings obtained using MRF.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven cases of breast cancer Exclusion Criteria: * Patients with onlybenign lesion * Patients with onlyductal carcinomain situ (DCIS) * Patients with recurrent/ residual breast cancer in same breast * Pregnant women * Lactating Women6.Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips. * The presence of an implanted medical device that is not MRI-compatible, including, but not limited to: pacemaker, defibrillator * Patients with contraindications for MRIdue to embedded foreign metallic objects. Bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient. * Known history of severe claustrophobia * Patients under the age of 18 * For patients with known history of allergic reaction to MR contrast material or abnormal kidney function (GFR \< 40 mL/ min), a contrast enhanced exam will not be performed; however, a non-contrast exam may be performed in these patients.
References
Publications (0)
Data not yet available
No reference posted for this study.