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

Breast Cancer Clinical Trial

Official title:

Role of Magnetic Resonance Fingerprinting and Quantitative MR Imaging in Assessment of Response to Neo-Adjuvant Chemotherapy in Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03650803
• Other study ID #: CASE3118
• Status: Completed
• Phase: N/A
• Start date: January 14, 2019
• Est. completion date: April 1, 2023

Study information

• Verified date: August 2023
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• 3D MR Fingerprinting scan
3D MR Fingerprinting technique is a non-contrast technique and generates quantitative information about MR-visible tumors without having to administer contrast. MR Fingerprinting software is used in conjunction with a standard-of-care MRI scan.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

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