Role of Magnetic Resonance Fingerprinting and Quantitative MR Imaging in Breast Cancer

Not Applicable

Completed

Conditions: Breast Cancer

Interventions: Device: 3D MR Fingerprinting scan

Registration Number: NCT03650803

Lead Sponsor: Case Comprehensive Cancer Center

Brief Summary: The purpose of this study is to determine if new methods of MRI imaging can better measure participants' response to chemotherapy treatment.

Detailed Description: The objectives of this study are to assess the utility of quantitative Magnetic Resonance Imaging (MRI) in assessment of response to neo-adjuvant chemotherapy in breast cancer. Magnetic Resonance (MR) Fingerprinting based relaxometry allows quantification of T1 and T2 relaxation times of tumor and normal breast tissue. Response to chemotherapy is associated with measurable changes in these properties and may be used to predict treatment response earlier than conventional MRI. The study team hypothesize that 3D MRF before, during and after chemotherapy can provide additional quantitative information about changes during treatment and may predict early response to chemotherapy.

During visit 1, 3D MR Fingerprinting images will be added to the clinical MRI scan before start of chemotherapy. The additional research images will take less than 20 minutes to acquire During visit 2, patients will be scheduled for a research only non-contrast 3D MR Fingerprinting scan 7-10 days after the first cycle of chemotherapy. Acquisition of images will take approximately 30 minutes.

During visit 3, if the treating physician orders a clinical MRI scan within 1 month of the end of chemotherapy treatment, the investigators will add a 3D MR Fingerprinting sequence to the clinical scan. The additional research images will take less than 20 minutes to acquire. If the patient is not scheduled for a clinical scan within 1 month of the end of chemotherapy treatment, the investigators will contact the patient to schedule a research only 3D MR Fingerprinting scan. The study team would like to administer IV gadolinium contrast for research purposes. Patients will be reconsented prior to the research only scan to determine whether or not they will receive IV contrast. If the patient declines administration of contrast for the post treatment scan, the study team will perform a non-contrast scan. Acquisition of images will take 30-45 minutes.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 14

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3D MR Fingerprinting scan	3D MR Fingerprinting scan	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.

Primary Outcome Measures

Name	Time	Method
Longitudinal Relaxation (T1) and Transverse Relaxation (T2) Times of Breast Tumor	2 years from start of study	From the 3D MR Fingerprinting maps, T1 and T2 relaxation times will be obtained from breast tumors at the baseline condition before the treatment.
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.	2 years from start of study	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.