N/A
N=14
Role of Magnetic Resonance Fingerprinting and Quantitative MR Imaging in Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03650803 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: 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. — -19.8; 5.4; -21.4; -7.1 Percentage change of relaxation time — p=0.046
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 3D MR Fingerprinting scan (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Case Comprehensive Cancer Center
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
-19.8; 5.4; -21.4; -7.1 | 0.046 sig |
| PRIMARY Longitudinal Relaxation (T1) and Transverse Relaxation (T2) Times of Breast Tumor |
1304.3; 1264.6; 77.0; 68.8 | 0.820 |
Summary
The purpose of this study is to determine if new methods of MRI imaging can better measure participants' response to chemotherapy treatment.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03650803). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.