|ACRIN||American College of Radiology Imaging Network|
|I-SPY TRIAL||Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and moLecular Analysis|
|CALGB||Cancer and Leukemia Group B|
|TCIA||The Cancer Imaging Archive|
|SER||Signal Enhancement Ratio|
|FTV||Functional Tumor Volume|
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.
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).
Further information can be found at:
- ACRIN 6657 Protocol http://www.acrin.org/6657_protocol.aspx
- I-SPY TRIAL http://ncicb.nci.nih.gov/tools/translation_research/isp
- CALGB 150007 http://www.cancer.gov/clinicaltrials/search/view?cdrid=69280&version=HealthProfessional
This is a limited access data set. To request access, please submit a concept sheet ((((link to ACRIN doc.))) to (ACRIN Contact).
If access is granted you will be able to view and download these images on The Cancer Imaging Archive (TCIA) by logging in and selecting the ISPY1 collection. This data set will be made publicly available on or before XXXX XX, 20XX.
Number of Patients
Number of Studies
Number of Series
Number of Images
|Images Size (GB)||76.2 GigaBytes|
This shared data set was provided by the Breast Imaging Research Program at UCSF, in collaboration with ACRIN, CALGB, the I-SPY TRIAL, and TCIA.
David Newitt, PhD, UCSF, Nola Hylton, PhD, UCSF
Funding sources include:
|UCSF||NIH R01 CA132870 and U01 CA151235|
NIH UO1 CA079778 and UO1 CA080098
|CALGB||NIH UO1 CA31964 and UO1 CA33601|
Many thanks are due to:
- The ACRIN 6657 trial team (((MAKE LINK TO FULL LIST )))
- The I-SPY 1 TRIAL team (((MAKE LINK TO FULL LIST )))
- All the patients participating in these studies