Trial Outcomes & Findings for Improved Breast MRI With SWIFT (NCT NCT01156987)
NCT ID: NCT01156987
Last Updated: 2017-03-09
Results Overview
Number of lesions detected
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
at time of read by two radiologiests, compared to biopsy within 7 days.
Results posted on
2017-03-09
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
23
|
|
Overall Study
COMPLETED
|
8
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improved Breast MRI With SWIFT
Baseline characteristics by cohort
| Measure |
Healthy Volunteers
n=8 Participants
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.
|
Breast Cancer Patients
n=23 Participants
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
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Lesion measurements
|
8 participants
n=5 Participants
|
23 participants
n=7 Participants
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at time of read by two radiologiests, compared to biopsy within 7 days.Number of lesions detected
Outcome measures
| Measure |
Healthy Volunteers
n=8 Participants
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.
|
Breast Cancer Patients
n=23 Participants
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
|
|---|---|---|
|
Lesions
|
0 lesions
|
12 lesions
|
Adverse Events
Healthy Volunteers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Breast Cancer Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place