An interventional study of Snapshot NIR V3.0 in Breast Cancer, Breast Reconstruction and Mastectomy, sponsored by National Research Council, Institute of Clinical Physiology, Italy. Completed at 1 site in Italy. Open to female participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by National Research Council, Institute of Clinical Physiology, Italy · Not applicable, Interventional, and Diagnostic
The goal of this single-center, nonrandomized, interventional non-profit pilot study is to evaluate the feasibility and clinical utility of a non-invasive near-infrared spectroscopy (NIRS) imaging device for assessing skin-flap tissue oxygen saturation in adult women undergoing mastectomy and immediate breast reconstruction after oncological surgery.
The main questions it aims to answer are:
Participants will:
NIRS imaging is performed for study purposes and does not influence intraoperative surgical decision-making or the choice of reconstructive procedure.
The ADISIRAST study is a single-center, non-randomized, pre-market, non-profit clinical investigation of a non-invasive near-infrared spectroscopy (NIRS) imaging device for the assessment of perfusion in mastectomy skin flaps in patients undergoing breast surgery with immediate reconstruction.
Mastectomy skin-flap viability is an important determinant of postoperative healing and reconstructive outcomes. In routine clinical practice, flap perfusion is mainly assessed through intraoperative inspection and surgical judgment. Objective methods for evaluating tissue oxygenation may provide complementary information and may help characterize regional perfusion patterns that are not readily apparent during standard clinical assessment.
Near-infrared spectroscopy is a non-invasive optical technique that estimates superficial tissue oxygen saturation (StO₂) by analyzing the relative absorption of near-infrared light by oxygenated and deoxygenated hemoglobin. The investigational device is a portable, non-contact NIRS imaging system that generates two-dimensional maps of superficial tissue oxygen saturation. The device does not require tissue contact, contrast-agent injection, or exposure to ionizing radiation. Acquisitions are performed by positioning the device at a standardized distance from the surgical area and obtaining a digital image together with the corresponding StO₂ map.
The study was designed to evaluate the feasibility, repeatability, and clinical interpretability of NIRS-derived StO₂ measurements in breast skin flaps throughout the perioperative period. NIRS images were acquired at predefined study time points, including a preoperative baseline assessment, an intraoperative assessment, and postoperative follow-up assessments(1 day and 15 days postoperative). This approach allowed the characterization of temporal changes in tissue oxygenation and the evaluation of regional differences within the skin flap.
Image analysis included assessment of absolute StO₂ values, regional oxygenation differences, spatial distribution of tissue areas within predefined StO₂ ranges, and longitudinal changes in oxygenation patterns. Regions of interest were defined within superior and inferior portions of the breast skin flap to explore regional perfusion heterogeneity. Additional image-derived metrics were calculated to quantify the extent of tissue area within selected StO₂ ranges and the degree of spatial heterogeneity of oxygenation.
Clinical and surgical data were prospectively collected, including reconstructive information, perioperative characteristics, postoperative flap healing, and clinically observed complications. NIRS findings were subsequently evaluated in relation to postoperative clinical observations, particularly the presence, location, and evolution of areas showing impaired healing or suspected ischemic changes.
Surgical planning and intraoperative decisions, including the choice of reconstructive approach, were made according to standard clinical practice, based on the treating surgical team's clinical assessment and preoperative evaluation. The operating surgeon was blinded to the intraoperative NIRS images, and NIRS findings did not influence surgical decision-making or the selection of the reconstructive procedure.
After study completion, NIRS-derived perfusion findings were retrospectively compared with the reconstructive strategy selected during surgery. This exploratory analysis was performed to assess the concordance between NIRS-based indications of flap perfusion and the clinical decision made by the surgical team. The analysis was intended to explore the potential future role of non-invasive tissue oxygenation imaging as an adjunctive tool for perioperative assessment and surgical training, rather than to evaluate a device-guided management strategy.
The study does not compare alternative surgical treatments or reconstructive techniques. It is designed as a feasibility and performance investigation and is not powered to establish definitive diagnostic thresholds, predict clinical outcomes with definitive accuracy, or demonstrate superiority of one reconstructive strategy over another. Data were collected prospectively and managed using coded participant identifiers.
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This study's enrollment of 20 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
Each patient enrolled in the study will undergo the standard diagnostic and treatment process. The only difference compared to patients not enrolled in the study will be the use of the experimental Snapshot NIR V3.0 device during the routine visits scheduled in any case, and in particular: during the preoperative consultation between the plastic surgeon and the breast surgeon, which must take place within 30 days prior to surgery; during the pre- and post-operative phases; on the first post-operative day during hospitalization; and on the 15th (+/-5 days) post-operative day during one of the routinely scheduled dressing changes.
Device: Snapshot NIR V3.0
The Snapshot NIR V3.0 device is used to noninvasively assess superficial breast skin flap tissue oxygenation and perfusion. NIR images and tissue oxygen saturation measurements are acquired preoperatively, early postoperatively, and at a later postoperative assessment.
Tissue Oxygen Saturation (StO₂) Measured by the Snapshot NIR V3.0 Device
Superficial tissue oxygen saturation (StO₂, %) measured using the Snapshot NIR V3.0 imaging device. StO₂ values (%) will be obtained from predefined Regions of Interest (ROIs) identified on exported two-dimensional tissue oxygenation maps. Mean StO₂ (%) and the presence of hypoperfused areas will be evaluated at each scheduled study visit.
Time frame: Baseline (preoperative), postoperative day 1, and postoperative day 15 (±5 days).
Correlation Between Snapshot NIR Tissue Oxygen Saturation (StO₂) and Clinical Assessment of Breast Skin Flap Perfusion
Correlation between superficial tissue oxygen saturation (StO₂, %) measured using the Snapshot NIR V3.0 device and the clinical assessment of breast skin flap perfusion performed by visual inspection. Clinical assessment findings and StO₂ measurements will be compared for the predefined Regions of Interest (ROIs). The outcome will be expressed as a correlation coefficient between StO₂ (%) measurements and the corresponding clinical assessment.
Time frame: Baseline (preoperative), postoperative day 1, and postoperative day 15 (±5 days).
Temporal Change in Tissue Oxygen Saturation (StO₂) of Breast Skin Flaps
Change in superficial tissue oxygen saturation (StO₂, %) measured using the Snapshot NIR V3.0 device over time. Serial StO₂ measurements obtained from predefined Regions of Interest (ROIs) will be compared across study visits to evaluate the temporal evolution of tissue perfusion and hypoperfused areas.
Time frame: Baseline (preoperative), postoperative day 1, and postoperative day 15 (±5 days).
Correlation Between Snapshot NIR Tissue Oxygen Saturation (StO₂) and Intraoperative Reconstructive Strategy
Correlation between tissue oxygen saturation (StO₂, %) measured using the Snapshot NIR V3.0 device and the intraoperative reconstructive strategy selected by the surgeon (prepectoral implant versus subpectoral tissue expander). The outcome will be expressed as the correlation between StO₂ (%) measurements and the selected reconstructive strategy.
Time frame: Intraoperative.
Plan to share: No — IPD will not be shared because participants consented only to aggregated data publication and due to confidentiality and privacy constraints.
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