Breast Screening
Conditions
Brief summary
The purpose of this study is to evaluate potential clinical efficacy of a novel magnetic resonance imaging (MRI) approach, MR fingerprinting, capable of providing quantitative measures of important tissue properties, which could provide important insights into normal breast tissue. This new MRI sequence will be added to the screening breast Dynamic Contrast Enhanced (DCE) MRI for high risk normal patients.
Detailed description
This is a feasibility study of the use of the additional MR fingerprinting (MRF) scanning sequence with a total of 12 minutes scanning time to our clinical screening breast DCE MRI examination before contrast medium injection and at the end of scan. This additional scanning sequence may provide faster and better quantitative tissue characterization comparing to conventional MR sequences. There is no investigational contrast agent in this study. We propose that the additional MRF sequence may provide faster and more accurate tissue characteristics imaging for clinical evaluation of breast tissue. Patients will be enrolled in with scheduled high risk screening DCE MRI (n=30). The MR imaging will be performed in the clinical 1.5T MR scanners in UNC as normally done for the patients MRI schedule. We only add an additional MRF sequence within the MRI exam just prior to the contrast enhancement scan. Quantitative measurement of the breast tissue will be performed after the MR exam. The region-of-interest (ROI) of normal breast parenchyma was recorded. The ROI will be saved and encoded to the T1 map, T2 map in MRF, T1 weighted imaging, T2 weighted imaging. A large variety of imaging ROI-based quantitative measures will be calculated among normal glands in bilateral breasts to evaluate different ROI characteristics among different patients and between bilateral breasts in each patient.
Interventions
DEVICEMR Fingerprinting
The MR fingerprinting technique requires less than 15 minutes total and will be added before and after the standard MRI sequence.
Sponsors
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* English-speaking patients * Ages 18 to 99 years old * Scheduled to undergo a screening breast MRI study * Capable and willing to provide signed informed consent
Exclusion criteria
* Claustrophobia * Presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes or near pelvis that would create excessive imaging artifact * Known hypersensitivity to contrast agent or to any component of contrast agent refractory to standard medications (antihistamines, steroids) * Impaired kidney function (serum creatinine level \> 1.8 mg/dl or a glomerular filtration rate \< 60 as approximated using serum creatinine levels) unless anuric and on dialysis. * Inability to tolerate MRI (e.g., inability to lie flat for \>1 hour) * Pregnancy or lactating female * Previous history of mastectomy or lumpectomy * Breast enhancements (i.e. implants)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of Intensity Score of Normal Breast Tissue for Left Breast Tissue Compared to Right for T1 Imaging Sequence | during MRI, approximately 1 hour | The normal breast tissue intensity value from the MRI will be used to compare between sides in same patient in the T1 sequence. The ratio of the left intensity score to the right intensity score will be averaged. The intensity value is a quantitative measurements of T1 relaxation time, an intrinsic magnetic tissue property that is correlated with a variety of pathological conditions. |
| Ratio of Intensity Score of Normal Breast Tissue for Left Breast Tissue Compared to Right for T2 Imaging Sequence | during MRI, approximately 1 hour | The normal breast tissue intensity value from the MRI will be used to compare between sides in same patient in the T2 sequence. The ratio of the left intensity score to the right intensity score will be averaged. The intensity value is a quantitative measurements of T2 relaxation time, an intrinsic magnetic tissue property that is correlated with a variety of pathological conditions. |
| Ratio of Intensity Score of Normal Breast Tissue for Left Breast Tissue Compared to Right for the Investigational (MRF) Imaging Sequence | during MRI, approximately 1 hour | The normal breast tissue intensity value from the MRI will be used to compare between sides in same patient in the investigational (MRF) sequence. The ratio of the left intensity score to the right intensity score will be averaged. The intensity value is a quantitative measurements of MRF relaxation time. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants will receive the investigational MR Fingerprinting sequence.
MR Fingerprinting: The MR fingerprinting technique requires less than 15 minutes total and will be added before and after the standard MRI sequence. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | technical issues with imaging sequence | 2 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants |
| Age, Continuous | 46.98 years STANDARD_DEVIATION 13.33 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 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 | 0 Participants |
| Race (NIH/OMB) White | 26 Participants |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
Primary
Ratio of Intensity Score of Normal Breast Tissue for Left Breast Tissue Compared to Right for T1 Imaging Sequence
The normal breast tissue intensity value from the MRI will be used to compare between sides in same patient in the T1 sequence. The ratio of the left intensity score to the right intensity score will be averaged. The intensity value is a quantitative measurements of T1 relaxation time, an intrinsic magnetic tissue property that is correlated with a variety of pathological conditions.
Time frame: during MRI, approximately 1 hour
Population: Two participants did not undergo the investigational sequence due to technical errors with the sequence at the time of the scan.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Ratio of Intensity Score of Normal Breast Tissue for Left Breast Tissue Compared to Right for T1 Imaging Sequence | 1.07 ratio | Standard Deviation 0.23 |
Primary
Ratio of Intensity Score of Normal Breast Tissue for Left Breast Tissue Compared to Right for T2 Imaging Sequence
The normal breast tissue intensity value from the MRI will be used to compare between sides in same patient in the T2 sequence. The ratio of the left intensity score to the right intensity score will be averaged. The intensity value is a quantitative measurements of T2 relaxation time, an intrinsic magnetic tissue property that is correlated with a variety of pathological conditions.
Time frame: during MRI, approximately 1 hour
Population: Two participants did not undergo the investigational sequence due to technical errors with the sequence at the time of the scan.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Ratio of Intensity Score of Normal Breast Tissue for Left Breast Tissue Compared to Right for T2 Imaging Sequence | 1.03 ratio | Standard Deviation 0.24 |
Primary
Ratio of Intensity Score of Normal Breast Tissue for Left Breast Tissue Compared to Right for the Investigational (MRF) Imaging Sequence
The normal breast tissue intensity value from the MRI will be used to compare between sides in same patient in the investigational (MRF) sequence. The ratio of the left intensity score to the right intensity score will be averaged. The intensity value is a quantitative measurements of MRF relaxation time.
Time frame: during MRI, approximately 1 hour
Population: Two participants did not undergo the investigational sequence due to technical errors with the sequence at the time of the scan.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Ratio of Intensity Score of Normal Breast Tissue for Left Breast Tissue Compared to Right for the Investigational (MRF) Imaging Sequence | 1.08 ratio | Standard Deviation 0.17 |