Trial Outcomes & Findings for Role of Magnetic Resonance Fingerprinting and Quantitative MR Imaging in Breast Cancer (NCT NCT03650803)
NCT ID: NCT03650803
Last Updated: 2024-06-20
Results Overview
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.
COMPLETED
NA
14 participants
2 years from start of study
2024-06-20
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Lost to Follow-up
|
6
|
Baseline Characteristics
Population excludes 6 participants who were lost to follow-up.
Baseline characteristics by cohort
| Measure |
3D MR Fingerprinting Scan
n=14 Participants
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.
|
|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=14 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=14 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=14 Participants
|
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Region of Enrollment
United States
|
14 participants
n=14 Participants
|
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Pathology
IDC Grade 2
|
2 Participants
n=8 Participants • Population excludes 6 participants who were lost to follow-up.
|
|
Pathology
IDC Grade 3
|
6 Participants
n=8 Participants • Population excludes 6 participants who were lost to follow-up.
|
|
Breast Parenchyma Composition
Fatty
|
1 Participants
n=8 Participants • Population excludes 6 participants who were lost to follow-up.
|
|
Breast Parenchyma Composition
Heterogeneously Dense
|
3 Participants
n=8 Participants • Population excludes 6 participants who were lost to follow-up.
|
|
Breast Parenchyma Composition
Dense
|
0 Participants
n=8 Participants • Population excludes 6 participants who were lost to follow-up.
|
|
Breast Parenchyma Composition
Extremely Dense
|
4 Participants
n=8 Participants • Population excludes 6 participants who were lost to follow-up.
|
|
Hormone Status
PPN
|
2 Participants
n=8 Participants • Population excludes 6 participants who were lost to follow-up.
|
|
Hormone Status
PNN
|
1 Participants
n=8 Participants • Population excludes 6 participants who were lost to follow-up.
|
|
Hormone Status
NNP
|
2 Participants
n=8 Participants • Population excludes 6 participants who were lost to follow-up.
|
|
Hormone Status
TN
|
2 Participants
n=8 Participants • Population excludes 6 participants who were lost to follow-up.
|
|
Hormone Status
PPP
|
1 Participants
n=8 Participants • Population excludes 6 participants who were lost to follow-up.
|
PRIMARY outcome
Timeframe: 2 years from start of studyPopulation: 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.
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.
Outcome measures
| Measure |
Responders to 3D MR Fingerprinting Scan
n=3 Participants
Patients with biopsy proven cases of breast cancer who were scheduled to undergo chemotherapy treatment were enrolled in this study. Quantitative MRF scans were acquired at the baseline before the treatment, 7-10 days after the first cycle of chemotherapy, and at the end of treatment. All MRF scans were acquired without any contrast administration. Final surgico-pathology results would be used for response assessment. Pathology reports with pT0N0 would be designated as pathological complete response or Responder in this study.
|
Non-Responders to 3D MR Fingerprinting Scan
n=5 Participants
Patients with biopsy proven cases of breast cancer who were scheduled to undergo chemotherapy treatment were enrolled in this study. Quantitative MRF scans were acquired at the baseline before the treatment, 7-10 days after the first cycle of chemotherapy, and at the end of treatment. All MRF scans were acquired without any contrast administration. Final surgico-pathology results would be used for response assessment. Presence of any residual tumor on pathology would be considered as Non-Responder in this study.
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|---|---|---|
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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
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5.4 Percentage change of relaxation time
Standard Deviation 9.9
|
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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
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-7.1 Percentage change of relaxation time
Standard Deviation 10.2
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PRIMARY outcome
Timeframe: 2 years from start of studyPopulation: 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.
From the 3D MR Fingerprinting maps, T1 and T2 relaxation times will be obtained from breast tumors at the baseline condition before the treatment.
Outcome measures
| Measure |
Responders to 3D MR Fingerprinting Scan
n=3 Participants
Patients with biopsy proven cases of breast cancer who were scheduled to undergo chemotherapy treatment were enrolled in this study. Quantitative MRF scans were acquired at the baseline before the treatment, 7-10 days after the first cycle of chemotherapy, and at the end of treatment. All MRF scans were acquired without any contrast administration. Final surgico-pathology results would be used for response assessment. Pathology reports with pT0N0 would be designated as pathological complete response or Responder in this study.
|
Non-Responders to 3D MR Fingerprinting Scan
n=5 Participants
Patients with biopsy proven cases of breast cancer who were scheduled to undergo chemotherapy treatment were enrolled in this study. Quantitative MRF scans were acquired at the baseline before the treatment, 7-10 days after the first cycle of chemotherapy, and at the end of treatment. All MRF scans were acquired without any contrast administration. Final surgico-pathology results would be used for response assessment. Presence of any residual tumor on pathology would be considered as Non-Responder in this study.
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|---|---|---|
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Longitudinal Relaxation (T1) and Transverse Relaxation (T2) Times of Breast Tumor
MRF T1 values before treatment
|
1304.3 milliseconds
Standard Deviation 121.5
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1264.6 milliseconds
Standard Deviation 266.6
|
|
Longitudinal Relaxation (T1) and Transverse Relaxation (T2) Times of Breast Tumor
MRF T2 values before treatment
|
77.0 milliseconds
Standard Deviation 6.6
|
68.8 milliseconds
Standard Deviation 24.8
|
Adverse Events
3D MR Fingerprinting Scan
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
3D MR Fingerprinting Scan
n=14 participants at risk
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.
|
|---|---|
|
Nervous system disorders
Nervous system disorders, Other: MRI exacerbated pre-existing Menier's Disease
|
7.1%
1/14 • Adverse events were monitored through study completion, up to 6 months for each enrolled patient.
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Additional Information
Dr. Holly Marshall
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place