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Background <p>The aim of this study was to validate the generalisability of the ECOG-ACRIN A6702 multicenter trial identified mean apparent diffusion coefficient (ADC) cutoff (1.53 × 10<sup>− 3</sup>mm<sup>2</sup>/s) and compare its biopsy reduction efficacy against a data-derived ADC minimum (ADC<sub>min</sub>) cutoff.</p> Methods <p>This dual-cohort retrospective analysis included 453 patients with 494 BI-RADS 4/5 lesions (derivation cohort: 288 patients/311 lesions; validation: 165 patients/183 lesions). ADC<sub>min</sub> and mean ADC (ADC<sub>mean</sub>) were measured, the data-derived ADC<sub>min</sub> cutoff was optimised via an ROC analysis (negative likelihood ratio ≤ 0.1) .Performance metrics included biopsy reduction rates, sensitivity, and false-negative rates, stratified by lesion type, size, BI-RADS category, and field strength.</p> Results <p>In the derivation cohort, the data-derived ADC<sub>min</sub> cutoff (1.39 × 10<sup>− 3</sup>mm<sup>2</sup>/s) showed comparable performance to the A6702 ADC<sub>mean</sub> (ADC<sub>ACRIN</sub>) cutoff in overall (24.7% vs. 24.1%), benign (47.9% vs. 45.1%) biopsy reduction and sensitivity (95.2% vs. 95.2%, all <i>P</i> &gt; 0.05), with its robustness confirmed by the validation cohort (26.2% overall, 57.9% benign reduction, 96.3% sensitivity). Both cutoffs exhibited field strength dependency, with higher biopsy reduction at 1.5T vs. 3.0T (derivation: 30.1% vs. 17.8% for ADC<sub>min</sub>, <i>P</i> = 0.01; validation: 28.7% vs.17.5% for ADC<sub>min</sub>).</p> Conclusions <p>The data-derived ADC<sub>min</sub> cutoff (1.39 × 10<sup>− 3</sup>mm<sup>2</sup>/s) demonstrated non-inferiority to the ADC<sub>ACRIN</sub> cutoff in biopsy reduction while preserving sensitivity. Observed performance variations between 1.5T and 3.0T suggest that field strength and other technical factors may influence cutoff efficacy. Prospective multicenter studies with standardized protocols are needed to validate its generalisability and clarify the role of field strength.</p>

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Reducing breast biopsy at MRI: comparison of minimum ADC cutoff and mean ADC cutoff identified by the ECOG-ACRIN A6702 multicenter trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月26日

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  • Fang Wu,
  • Fangyi Xu,
  • Jie He,
  • Hongjie Hu,
  • Xia Song,
  • Shufeng Fan,
  • Dongying Su

摘要

Background

The aim of this study was to validate the generalisability of the ECOG-ACRIN A6702 multicenter trial identified mean apparent diffusion coefficient (ADC) cutoff (1.53 × 10− 3mm2/s) and compare its biopsy reduction efficacy against a data-derived ADC minimum (ADCmin) cutoff.

Methods

This dual-cohort retrospective analysis included 453 patients with 494 BI-RADS 4/5 lesions (derivation cohort: 288 patients/311 lesions; validation: 165 patients/183 lesions). ADCmin and mean ADC (ADCmean) were measured, the data-derived ADCmin cutoff was optimised via an ROC analysis (negative likelihood ratio ≤ 0.1) .Performance metrics included biopsy reduction rates, sensitivity, and false-negative rates, stratified by lesion type, size, BI-RADS category, and field strength.

Results

In the derivation cohort, the data-derived ADCmin cutoff (1.39 × 10− 3mm2/s) showed comparable performance to the A6702 ADCmean (ADCACRIN) cutoff in overall (24.7% vs. 24.1%), benign (47.9% vs. 45.1%) biopsy reduction and sensitivity (95.2% vs. 95.2%, all P > 0.05), with its robustness confirmed by the validation cohort (26.2% overall, 57.9% benign reduction, 96.3% sensitivity). Both cutoffs exhibited field strength dependency, with higher biopsy reduction at 1.5T vs. 3.0T (derivation: 30.1% vs. 17.8% for ADCmin, P = 0.01; validation: 28.7% vs.17.5% for ADCmin).

Conclusions

The data-derived ADCmin cutoff (1.39 × 10− 3mm2/s) demonstrated non-inferiority to the ADCACRIN cutoff in biopsy reduction while preserving sensitivity. Observed performance variations between 1.5T and 3.0T suggest that field strength and other technical factors may influence cutoff efficacy. Prospective multicenter studies with standardized protocols are needed to validate its generalisability and clarify the role of field strength.