DCE + Derived Only
Clinical and outcome data
|Level 0: Complete image data set||222||NA|| NA |
|Level 1: Studies with MRI LD measurements||219|| NA || NA |
|Level 2a: Studies with SER Volume measurements||207|
|Level 3: Studies used in primary aim analysis||162|
Level 0: Complete I-SPY 1 / ACRIN 6657 MRI Dataset
This data set is comprised of all HIPPA compliant, DICOM compliant MRI series.
Level 0 image data set consists of 847 on-study MRI studies on 222 subjects in the UCSF image database.
One patient in the image data collection (I-SPY ID 1079 ) does not appear in the Feb. 2, 2011 I-SPY FINAL LOCKED clinical data dump. So no clinical or outcome data is available for this subject.
Level 1: MRI exams for which longest diameter was measured
This data set is comprised of all studies with MRI measured longest diameter (LD) values reported.
839 MRI studies have LD reported in the I-SPY 1 clinical database, of which 5 studies are not present in either the UCSF or ACRIN image data collections (see Table 1).
Level 1 image data set consists of 834 MRI studies on 219 subjects in the UCSF image database
Table 1. Studies that have LD measurement but are missing from
the UCSF and ACRIN TRIAD image data collections:
ID 1071, T1
ID 1138, T1
ID 1101, T3
ID 1040, T4
ID 1187, T4
Level 2a: Good SER Volume Dataset – updated 9/3/14, 9/17/16
This data set is comprised of the patient studies which, following quality reviews in 2014 and 2016, were judged to have sufficiently good image quality and protocol compliance for volumetric DCE SER analysis. Rejection criteria included: incomplete volumetric DCE acquisitions, lack of a 2nd post-contrast acquisition, variability in fat suppression across the image, observed patient motion during the DCE acquisition, significant DCE protocol deviations such as changing scan parameters or image position during DCE acquisition.
Level 2a image data set consists of 706 MR studies on 207 subjects in the UCSF image database. These include 7 studies not included in Level 1 (no MRI LD recorded) as listed in Table 2.
Table 2. Studies in Level 2a (good volumetric analysis) that do NOT have LD measures:
ID 1059, T4
ID 1079, T2 *
ID 1104, T4
ID 1192, T2
ID 1212, T4
ID 1215, T1
ID 1238, T2
- Patient 1079 does not appear in the Feb. 2, 2011 I-SPY FINAL LOCKED clinical data set. So no clinical or outcome data is available.
Level 2b: SER Volume Dataset Reported in Hylton et al. (Radiology, 2012) *
This data set is comprised of the patient studies analyzed for pCR outcome and reported in the 2012 Radiology paper on ACRIN 6657 pCR results *. This data set is not provided as a shared list, as it is not recommended for use in further analysis. It is described here because it is the data set from which the Level 3 (primary aim analysis) set was derived. Inclusion and exclusion was determined by quality and protocol reviews available at that time. In addition to the exclusion criteria listed for Level 2a, studies done with imaging in the axial plane, in violation of the sagittal orientation specified in the trial imaging protocol, were excluded due to processing limitations of the analysis software. Similarly, bi-lateral sagittal acquisitions (alternating left and right volumetric acquisitions) were excluded.
Level 2b image data set consists of 707 MRI studies on 207 subjects in the UCSF image database.
- Hylton NM, Blume JD, Bernreuter WK, et al: Locally advanced breast cancer: MR imaging for prediction of response to neoadjuvant chemotherapy--results from ACRIN 6657/I-SPY TRIAL. Radiology 263:663-72, 2012
Tables 3 and 4 show the specific inclusion/exclusion differences between Levels 2a and 2b:
Table 3. 16 studies accepted for SER analysis since 2008 (in Level 2a but not in 2b)
ID 1005, T3
ID 1043, T2
ID 1046, T4
ID 1057, T3
ID 1074, T3
ID 1084, T1
ID 1110, T4
ID 1139, T4
ID 1159, T4
ID 1176, T2
ID 1201, T2
ID 1203, T4
ID 1206, T4
ID 1225, T3
ID 1219, T3
ID 1228, T4
| Table 4. 17 studies rejected since 2008 (in Level 2b but not in 2a) |
|Study ID and TP||Reason for rejection for volumetric SER analysis (level 2a)|
1007 T4 *
|No fatSat; Different protocol from T1|
|1035 T4 *||Only 1 post scan then acq. parameters changed|
|1045 T1||Alternating laterality acquisitions, 2 minute time gap|
|1047 T1 *||Image position changed during DCE|
|1053 T2 *||Alternating laterality acquisitions, bad pre- acquisition|
|1053 T4 *||Alternating laterality acquisitions|
|1055 T1 *||Alternating laterality acquisitions, 4 minute time gap|
|1086 T1 *||Alternating laterality acquisitions, time gap, different protocol from T4|
|1091 T1 *||Changing acq. parameters during DCE|
|1095 T2 *||Only 1 post scan then acq. parameters changed|
|1173 T3 *||Off protocol timing|
|1206 T1||Bad DCE timing, 20 minute delay|
|1206 T2||Bad DCE timing, 1'29" acquisition time|
|1224 T3 *||Scan position changed during DCE|
|1230 T3 *||Scan position changed during DCE|
|#128 T1, T2||2 studies for ineligible patient: ACRIN ID 128 (no I-SPY ID)|
- Subjects that were included in the primary aim analysis (Level 3)
Level 3: Subset of Level 2b used in primary aim analysis, reported in Hylton et al. (Radiology, 2016) *
This data set is comprised of the patient studies analyzed for RFS outcome and reported in the 2015 Radiology paper on ACRIN 6657 survival results (Hylton et al, Radiology *). Table 5 shows the 45 patients excluded from the level 2a cohort for this analysis. Please see the publication for specific information on exclusions of patients from this group.
Level 3 image data set consists of 586 MRI studies on 162 subjects in the UCSF image database. This is also the study cohort used as the Test Phase data in the QIN BMMR Challenge.
|Table 5. 45 subjects excluded from Level 2b set|