Page History

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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 multicenter Investigation of of Serial Studies to to Predict redict Your our Therapeutic herapeutic Response with with Imaging and moLecular ecular Analysis (I-SPY TRIAL) breast cancer trial, a study of imaging and tissue-based biomarkers for predicting pathologic complete response and survivalAdd protocol references for all three studies.
(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.

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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. Voluetric Volumetric analysis, including Quality Control assessment, was performed centrally at the breast MR imaging laboratory at University of California at San Francisco (UCSF).

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((( Insert full acknowledgement lists here )))

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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

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• 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 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.

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To download: Tools / Search Shared Lists

Data Dictionary

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I SPY-1 / ACRIN 6657 Data Dictionaries

 . Also included are descriptions of ancillary data provided, including demographic, clinical and survival data.