Breast Cancer
Conditions
Keywords
3D MR Fingerprinting, Quantitative MR Imaging
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.
Interventions
DEVICE3D 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.
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 6 |
Baseline characteristics
| Characteristic | 3D MR Fingerprinting Scan |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Breast Parenchyma Composition Dense | 0 Participants |
| Breast Parenchyma Composition Extremely Dense | 4 Participants |
| Breast Parenchyma Composition Fatty | 1 Participants |
| Breast Parenchyma Composition Heterogeneously Dense | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Hormone Status NNP | 2 Participants |
| Hormone Status PNN | 1 Participants |
| Hormone Status PPN | 2 Participants |
| Hormone Status PPP | 1 Participants |
| Hormone Status TN | 2 Participants |
| Pathology IDC Grade 2 | 2 Participants |
| Pathology IDC Grade 3 | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 1 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
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.
Time frame: 2 years from start of study
Population: Only the participants who have completed at least the first two MRF scans were included in this data analysis. Six participants are excluded due to being lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Responders to 3D MR Fingerprinting Scan | Longitudinal Relaxation (T1) and Transverse Relaxation (T2) Times of Breast Tumor | MRF T1 values before treatment | 1304.3 milliseconds | Standard Deviation 121.5 |
| Responders to 3D MR Fingerprinting Scan | Longitudinal Relaxation (T1) and Transverse Relaxation (T2) Times of Breast Tumor | MRF T2 values before treatment | 77.0 milliseconds | Standard Deviation 6.6 |
| Non-Responders to 3D MR Fingerprinting Scan | Longitudinal Relaxation (T1) and Transverse Relaxation (T2) Times of Breast Tumor | MRF T1 values before treatment | 1264.6 milliseconds | Standard Deviation 266.6 |
| Non-Responders to 3D MR Fingerprinting Scan | Longitudinal Relaxation (T1) and Transverse Relaxation (T2) Times of Breast Tumor | MRF T2 values before treatment | 68.8 milliseconds | Standard Deviation 24.8 |
Comparison: MRF T1 relaxation timep-value: 0.82t-test, 2 sided
Comparison: MRF T2 relaxation timep-value: 0.605t-test, 2 sided
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.
Time frame: 2 years from start of study
Population: Only the participants who have completed at least the first two MRF scans were included in this data analysis. Six participants are excluded due to being lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Responders to 3D MR Fingerprinting Scan | 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. | MRF T1 Changes | -19.8 Percentage change of relaxation time | Standard Deviation 19.3 |
| Responders to 3D MR Fingerprinting Scan | 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. | MRF T2 Changes | -21.4 Percentage change of relaxation time | Standard Deviation 4.2 |
| Non-Responders to 3D MR Fingerprinting Scan | 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. | MRF T1 Changes | 5.4 Percentage change of relaxation time | Standard Deviation 9.9 |
| Non-Responders to 3D MR Fingerprinting Scan | 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. | MRF T2 Changes | -7.1 Percentage change of relaxation time | Standard Deviation 10.2 |
Comparison: MRF T1 Changesp-value: 0.046t-test, 1 sided
Comparison: MRF T2 Changesp-value: 0.064t-test, 2 sided