Breast Cancer
Conditions
Brief summary
Today's medical imaging methods have insufficient specificity for reliable differentiation between benign and malignant breast lesions in patients. Pathologic evaluation is currently the only way to obtain a definitive diagnosis. This research will use a novel method of magnetic resonance imaging (MRI), Sweep Imaging with Fourier Transform (SWIFT), at a very high magnetic field (4 Tesla) to distinguish malignant from benign breast lesions. This research will reveal whether the SWIFT sequence bears new capabilities in medical imaging for breast cancer diagnosis.
Detailed description
Patients will be asked to come to the Center for Magnetic Resonance Research (CMRR) at the University of Minnesota. Researchers will interview the patient and describe procedures and risks. An intravenous (IV) line will be placed in an upper extremity for infusing magnetic resonance imaging (MRI) contrast dye. Baseline MRI scans will be done. These MRI measurements will be compared with clinical, radiological and pathological findings (the gold standard). Follow-up contact will occur within one year after the MRI to determine whether a pathology report is available.
Interventions
DEVICEMagnetic resonance imaging
Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows: * an IV line is placed by nurse, * patient is placed in the 4 T MRI scanner at CMRR, * initial scout images and manual linear shims are adjusted, * Pre-contrast SWIFT T1 weighted images and T1 map are obtained, * continuous SWIFT acquisition begins immediately before contrast injection, * contrast injection, * continuous SWIFT acquisition continues for 12 min after contrast, * late enhancement images may also be obtained. 10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods.
Sponsors
National Cancer Institute (NCI)
University of Minnesota
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Women with a clinically or mammographically identified suspicious breast mass that is likely to be biopsied or surgically removed.
Exclusion criteria
* Pregnancy * Ferromagnetic implants * History of shotgun wounds and shrapnel * Obesity (\>250 pounds) * Cardiac pacemaker * Incompatible implanted medical device * Severe claustrophobia * Major surgeries with potential of ferromagnetic implants * Severe asthma and allergies * i-STAT system, a handheld blood analyzer (I-STAT) creatinine test, estimated glomerular filtration rate (GFR) \<30 * Metallic object (greater than 2 cm in length) in the breast * Metallic ink tatoo within 20 cm of the breast (approximately 8 inches)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lesions | at time of read by two radiologiests, compared to biopsy within 7 days. | Number of lesions detected |
Countries
United States
Participant flow
Pre-assignment details
31 were consented to enroll to start study with 23 breast cancer subjects and 8 healthy controls being able to complete the portion of the MRI study needed for analysis.
Participants by arm
| Arm | Count |
|---|---|
| Healthy Volunteers Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.
Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:
* an IV line is placed by nurse,
* patient is placed in the 4 T MRI scanner at CMRR,
* initial scout images and manual linear shims are adjusted,
* Pre-contrast SWIFT T1 weighted images and T1 map are obtained,
* continuous SWIFT acquisition begins immediately before contrast injection,
* contrast injection,
* continuous SWIFT acquisition continues for 12 min after contrast,
* late enhancement images may also be obtained.
10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods. | 8 |
| Breast Cancer Patients Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.
Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:
* an IV line is placed by nurse,
* patient is placed in the 4 T MRI scanner at CMRR,
* initial scout images and manual linear shims are adjusted,
* Pre-contrast SWIFT T1 weighted images and T1 map are obtained,
* continuous SWIFT acquisition begins immediately before contrast injection,
* contrast injection,
* continuous SWIFT acquisition continues for 12 min after contrast,
* late enhancement images may also be obtained.
10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar | 23 |
| Total | 31 |
Baseline characteristics
| Characteristic | Healthy Volunteers | Breast Cancer Patients | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 23 Participants | 31 Participants |
| Lesion measurements | 8 participants | 23 participants | 31 participants |
| Sex: Female, Male Female | 8 Participants | 23 Participants | 31 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 23 |
| serious Total, serious adverse events | 0 / 8 | 0 / 23 |
Outcome results
Primary
Lesions
Number of lesions detected
Time frame: at time of read by two radiologiests, compared to biopsy within 7 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Healthy Volunteers | Lesions | 0 lesions |
| Breast Cancer Patients | Lesions | 12 lesions |