Summary
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ACRIN 6657 was designed as a prospective study to test MRI for ability to predict response to treatment and risk-of-recurrence in patients with stage 2 or 3 breast cancer receiving neoadjuvant chemotherapy (NACT). ACRIN 6657 was conducted as a companion study to CALGB 150007, a correlative science study evaluating tissue-based biomarkers in the setting of neoadjuvant treatment of breast cancer. Collectively, CALGB 150007 and ACRIN 6657 formed the basis of the multicenter Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and moLecular Analysis (I-SPY TRIAL) breast cancer trial, a study of imaging and tissue-based biomarkers for predicting pathologic complete response (pCR) and recurrence-free survival (RFS). |
Participant Eligibility and Enrollment: Criteria for inclusion were patients enrolling on CALGB 150007 with T3 tumors measuring at least 3 cm in diameter by clinical exam or imaging and receiving neoadjuvant chemotherapy with an anthracycline-cyclophosphamide regimen alone or followed by a taxane. Pregnant patients and those with ferromagnetic prostheses were excluded from the study. The study was open to enrollment from May 2002 to March 2006. 237 patients were enrolled, of which 230 met eligibility criteria.
Acknowledgements
This shared data set was provided by David Newitt, PhD and Nola Hylton, PhD from the Breast Imaging Research Program at UCSF, in collaboration with ACRIN, CALGB, the I-SPY TRIAL, and TCIA. Many thanks are due to The ACRIN 6657 trial team , The I-SPY 1 TRIAL team , and all the patients participating in these studies
Funding sources include NIH grants to UCSF (R01 CA132870 and U01 CA151235), ACRIN (UO1 CA079778 and UO1 CA080098), and CALGB (UO1 CA31964 and UO1 CA33601).
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title | Detailed Description |
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Detailed Description
Collection Statistics |
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Modalities | MR, SEG |
Number of Patients | 222 |
Number of Studies | 847 |
Number of Series | 7880 |
Number of Images | 386,528 |
Images Size (GB) | 76.2 GigaBytes |
Requirements for MR imaging (As specified in the ACRIN 6657 protocol )
Imaging time points: MRI exams were performed within four weeks prior to starting anthracycline-cyclophosphamide chemotherapy (T1, MRI1), at least 2 weeks after the first cycle of AC and prior to the second cycle of AC (T2, MRI2), between anthracycline-cyclophosphamide treatment and taxane therapy if taxane was administered (T3, MRI3), and after the final chemotherapy treatment and prior to surgery (T4, MRI4). The study schema is shown in Figure 1
Figure 1. CALGB 150007 and ACRIN 6657 study schema.
Imaging protocol: MR imaging was performed on a 1.5 Tesla field strength scanner using a dedicated breast radiofrequency coil. The image acquisition protocol included a localization scan and T2-weighted sequence followed by a contrast-enhanced T1-weighted series. All imaging was performed unilaterally over the symptomatic breast and in the sagittal orientation. The contrast-enhanced series consisted of a high resolution (≤1mm in-plane spatial resolution) three-dimensional, fat-suppressed, T1-weighted gradient echo sequence with TR≤20 ms, TE = 4.5 ms, flip angle ≤ 45º, 16-18 cm field-of-view, minimum matrix 256x192, 64 slices, slice thickness ≤ 2.5 mm. Scan time length for the T1-weighted sequence was required to be between 4.5 and 5 minutes. The sequence was acquired once before contrast injection and repeated at least twice following injection.
Tumor diameter measurement and volumetric analysis: Tumor longest diameter (LD) was measured by the site radiologist as the greatest extent of disease on baseline MR images, including intervening areas of non-enhancing tissue. The same measurement direction was used on all subsequent MRI exams. The primary predictor variable, functional tumor volume (FTV) was measured from contrast-enhanced images using the signal enhancement ratio (SER) method. Volumetric analysis, including Quality Control assessment, was performed centrally at the Breast Imaging Research Program (BIRP) laboratory at University of California at San Francisco (UCSF).
Detailed information about the DICOM data is available in the DICOM Dictionary.
Further information on these studies can be found at:
- ACRIN 6657 Protocol http://www.acrin.org/6657_protocol.aspx
- CALGB 150007 http://www.cancer.gov/clinicaltrials/search/view?cdrid=69280&version=HealthProfessional
Imaging Data Transfer History
The processing of the MR image data for ACRIN 6657 consisted of the following steps between image acquisition and the creation of this shared data set on TCIA:
- MRI studies were sent from the study centers to the ACRIN Core Lab either via media (DVD) or the TRIAD program
- Image data were de-identified and centrally archived at the ACRIN Core Lab
- Archived data was sent to the Breast Imaging Research Program (BIRP) at the University of California, San Francisco (UCSF) for volumetric analysis.
- De-identified image data, derived analysis maps and segmentations, and ancillary data files were transferred from UCSF to TCIA for data sharing.
While every effort was made to preserve the integrity of both the original image data and image meta-data (DICOM attributes, public and private), multiple file transfers and strict adherence to HIPPA guidelines for patient confidentiality may have resulted in loss of some data. If any questions arise, or patient PHI is found in any data on this collection, please contact the UCSF Breast Imaging Research Program (BIRP).
Curated Data Sets
In addition to the complete set of ACRIN 6657 imaging studies ("Level 0" data), the following curated data sets based on UCSF QC assessment, protocol compliance and data completeness are provided:
- Level 1: MRI Longest Diameter (LD)
- Level 2a: SER Volume Dataset for ongoing volumetric analyses (updated 9/17/16)
- Level 2b: SER Volume Dataset for pCR Analysis (Hylton, et al; Radiology 2012)
- Level 3: SER Volume Dataset for RFS Analysis (Hylton, et al; Radiology, 2016)
The image data sets are accompanied by Excel files with selected patient clinical and outcome data.
Data Set Descriptions
Level 0: Complete I-SPY 1 / ACRIN 6657 MRI Dataset
This data set is comprised of all HIPPA compliant, DICOM compliant MRI series.
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title | Citations & Data Usage Policy |
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Citations & Data Usage Policy
This collection is freely available to browse, download, and use for commercial, scientific and educational purposes as outlined in the Creative Commons Attribution 3.0 Unported License. See TCIA's Data Usage Policies and Restrictions for additional details. Questions may be directed to help@cancerimagingarchive.net.
Please be sure to include the following citations in your work if you use this data set:
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David Newitt, Nola Hylton, on behalf of the I-SPY 1 Network and ACRIN 6657 Trial Team. (2016). Multi-center breast DCE-MRI data and segmentations from patients in the I-SPY 1/ACRIN 6657 trials. The Cancer Imaging Archive. http://doi.org/10.7937/K9/TCIA.2016.HdHpgJLK |
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Hylton NM, Gatsonis CA, Rosen MA, et al: Neoadjuvant Chemotherapy for Breast Cancer: Functional Tumor Volume by MR Imaging Predicts Recurrence-free Survival-Results from the ACRIN 6657/CALGB 150007 I-SPY 1 TRIAL. Radiology 279:44-55, 2016. |
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Clark K, Vendt B, Smith K, Freymann J, Kirby J, Koppel P, Moore S, Phillips S, Maffitt D, Pringle M, Tarbox L, Prior F. The Cancer Imaging Archive (TCIA): Maintaining and Operating a Public Information Repository, Journal of Digital Imaging, Volume 26, Number 6, December, 2013, pp 1045-1057. (paper) |
Other Publications Using This Data
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