Specificity of Celbrea, a novel noninvasive thermal screening device, in women with recent negative screening mammograms.

BACKGROUND

Breast cancer screening through mammography (MAM) remains the gold standard for early detection. However, MAM implementation faces several challenges, including psychological barriers, resource constraints, and reduced sensitivity in certain populations. Novel screening tools, complementary to mammography, may improve breast cancer detection rates and patient adherence to screening. This study evaluated whether negative results from Celbrea, a novel thermal-based device, were in agreement with negative MAM findings.

METHODS

We conducted a single-center retrospective cohort study at an imaging center in Memphis, Tennessee. Eligible participants were healthy women aged 25-80 years with bra cup size D or smaller, normal breast skin, and no prior breast cancer diagnosis undergoing routine annual screening MAM. Participants were screened with Celbrea, an FDA-cleared thermal device for breast disease detection. MAM results were classified as negative (BI-RADS 1 or 2) or positive. Celbrea results were classified as either: non-significant (temperature differential ≤2°F) or significant. We calculated specificity and negative predictive value (NPV) using confusion matrices.

RESULTS

Of 77 enrolled women, 68 had conclusive results for Celbrea. After excluding 5 women with BI-RADS 0 MAM, 63 were included in the final diagnostic performance analysis. Among these, 56 had negative results on both tests, 1 had a positive MAM (BI-RADS 3) with a non-significant Celbrea result, and 6 had negative MAM with significant Celbrea findings. Overall specificity was 90.3% (95% CI: 80.1-96.4) and NPV was 98.3% (95% CI: 90.6-100.0). Among women with almost entirely fatty or scattered fibroglandular tissue (n=35), specificity was 85.3% (95% CI: 68.9-95.1) and NPV was 96.7% (95% CI: 82.8-99.9). Among women with heterogeneously or extremely dense breasts (n=28), specificity was 96.4% (95% CI: 81.7-99.9) and NPV was 100.0% (95% CI: 87.2-100.0).

CONCLUSIONS

Celbrea showed concordance of negative results with MAM. These findings demonstrate good discriminatory capacity and suggest potential clinical utility as an adjunctive or triage tool.