Clinical validation
What the two published studies show
MamoRef has, to date, two peer-reviewed clinical studies, both at Hospital Privado de la Comunidad (HPC), Mar del Plata — a high-complexity hospital with a mastology unit accredited since 2018. These are two distinct studies with distinct goals: we keep them separate here, as published, rather than blending their numbers.
Usability and patient comfort
Between designing the device and validating it clinically, there's a less visible piece of work that matters just as much: making sure that lying down on the stretcher and going through the study is a comfortable, clear experience. MamoRef went through two prototype generations, and each one was evaluated on that front too, not only on diagnostic accuracy.
Prototype V1 (2020–2023) — TRL 5.5
- 2 prototypes built and tested.
- Clinically validated at Hospital Privado de la Comunidad (HPC).
- The usability evaluation identified comfort and ergonomics issues, which shaped the redesign of the next prototype.
Prototype V2 (2023–2025) — TRL 6
- 3 prototypes built and tested, with a more ergonomic design.
- Clinically validated at Hospital Británico and INTECNUS.
- The usability test showed very good results and high acceptance among patients.
Feasibility study (Carbone et al. 2024, Phys. Med. Biol.)
The first paper describes the device's design and an initial clinical feasibility study: at the time of writing, 42 measurements had been made on volunteers. The paper presents two representative cases in detail:
Case 1 · Invasive ductal carcinoma
- Mammography: oval, hyperdense 24×28 mm lesion with microcalcifications, upper outer quadrant of the left breast (hour 1). BI-RADS IV.
- Biopsy: invasive ductal carcinoma (NST), Nottingham grade II.
- MamoRef: periareolar region of higher metabolism/absorption, irregular margins, 32×25 mm — consistent with the mammography and ultrasound findings.
Case 2 · Fibroadenoma
- Ultrasound: ovoid hypoechoic image, 23.3 mm, well-defined margins, no apparent vascularization, hour 7. BI-RADS III.
- Biopsy: fibroadenoma, no atypia.
- MamoRef: no focal areas of increased metabolism (only the expected nipple pigmentation) — consistent with a low-vascularity lesion.
Prospective study (Carbone et al. 2026, Technology in Cancer Research & Treatment)
The second paper is a more formal prospective study, carried out between April and November 2023 at HPC, approved by its ethics board (CIREI) and authorized by the Buenos Aires Province Ministry of Health. 21 patients were included, all of whom already required a core biopsy due to suspicious findings on mammography, ultrasound, or MRI (one was excluded from the final analysis because her lesion could not be adequately biopsied). Of all biopsies performed, 7 were cancer (2 of them in situ); the rest were benign lesions (fibroadenomas, fibrosis, periductal mastitis, among others).
Of the MamoRef studies performed, 4 were discarded for artifacts (incomplete breast support on the window, reflections from scratches on the acrylic, patient movement), leaving 17 evaluable sets of maps. Five NIRS-specialized professionals, blinded to each case's diagnosis, scored each image set on a 6-point scale (0 to 5) modeled after BI-RADS, from "normal tissue" to "highly suggestive of malignancy."
Statistical results
At the threshold that maximizes Youden's J statistic on the ROC curve (0.6):
- AUC = 0.77
- Accuracy: 70% (90% CI: 55%–85%)
- Sensitivity: 62% (90% CI: 33%–87%)
- Specificity: 74% (90% CI: 56%–90%)
Comparing MamoRef's maps against pathology (biopsies) showed close to 80% agreement. Agreement among the 5 evaluators (Fleiss' kappa) was 0.253 — "slight" to "fair": expected for a first clinical experience, with evaluators who had no prior training interpreting this new kind of image.
How it compares to standard techniques
| Technique | Accuracy | Sensitivity | Specificity | AUC |
| MamoRef | 70% | 62% | 74% | 0.77 |
| Mammography | 71.8% | 34%–60%* | 80%–91%* | 0.73 |
| Ultrasound | 46.9% | 47%–100%* | 19%–100%* | 0.768 |
| MRI | — | 55%–92%* | 70%–88%* | 0.93 |
*Ranges from different studies cited in the literature (see Table 5, Carbone et al. 2026) — the spread across studies for the same technique is itself a sign of how hard it is to pin down definitive reference values. MamoRef's confidence intervals are wide given the still-small sample size.
What the authors say about the limitations: both papers are explicit that these are preliminary results, from first-generation prototypes, with small samples and evaluators with no prior experience interpreting these images. The authors themselves expect accuracy, sensitivity, and inter-rater agreement to improve with more cases, better-trained personnel, and the AI-assisted reconstruction algorithm they're developing (a U-Net-style convolutional neural network trained on Monte Carlo simulations, also aiming for depth resolution).