ADisIRast: Applicazione Del Dispositivo NIR Nella Breast Unit. Studio Pilota Monocentrico, Non Randomizzato, Interventistico Con Dispositivo Medico, Premarket, Non Profit, Per la Valutazione Della Perfusione Del Lembo Cutaneo Pre e Post Operatoria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Tissue Oxygen Saturation (StO₂) Measured by the Snapshot NIR V3.0 Device
研究概览
简要总结
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:
- Can NIRS imaging provide reproducible measurements of tissue oxygen saturation (StO₂) in mastectomy skin flaps before surgery, during the intraoperative phase, and during postoperative follow-up?
- Can spatial and temporal variations in StO₂ identify areas of potentially reduced flap perfusion or impaired tissue viability?
- Can NIRS-derived oxygenation measurements support the assessment of postoperative flap healing and ischemic complications?
Participants will:
- undergo non-invasive NIRS imaging of the breast skin flap before surgery;
- undergo one intraoperative NIRS acquisition during mastectomy and immediate breast reconstruction;
- undergo repeated NIRS imaging during postoperative follow-up visits;
- receive standard surgical treatment and postoperative care according to routine clinical practice.
NIRS imaging is performed for study purposes and does not influence intraoperative surgical decision-making or the choice of reconstructive procedure.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female sex, aged 18 to 90 years.
- •Breast cancer patients scheduled for mastectomy with immediate reconstruction using an implant or tissue expander; or healthy BRCA mutation carriers scheduled for prophylactic mastectomy.
- •No previous radiotherapy to the chest wall.
- •No previous neoadjuvant chemotherapy.
排除标准
- •Severe psychiatric disorders.
- •Advanced malignancy.
- •Severe aortic stenosis.
- •Obstructive hypertrophic cardiomyopathy.
- •Severe chronic kidney disease.
- •Severe chronic obstructive pulmonary disease.
- •Uncontrolled diabetes mellitus.
- •Advanced peripheral arterial occlusive disease (Leriche-Fontaine class III).
- •Use of benzodiazepines, non-benzodiazepine hypnotics, typical or atypical antipsychotics, antidepressants, or anticonvulsants without a stable dose for at least 4 months.
- •Alcohol, caffeine, or other substance abuse.
- •Inability to reasonably adhere to study procedures.
- •Pregnancy or breastfeeding.
- •Concurrent participation in another clinical trial.
- •Withdrawal of informed consent.
结局指标
主要结局
Tissue Oxygen Saturation (StO₂) Measured by the Snapshot NIR V3.0 Device
时间窗: Baseline (preoperative), postoperative day 1, and postoperative day 15 (±5 days).
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.
Correlation Between Snapshot NIR Tissue Oxygen Saturation (StO₂) and Clinical Assessment of Breast Skin Flap Perfusion
时间窗: Baseline (preoperative), postoperative day 1, and postoperative day 15 (±5 days).
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.
Temporal Change in Tissue Oxygen Saturation (StO₂) of Breast Skin Flaps
时间窗: Baseline (preoperative), postoperative day 1, and postoperative day 15 (±5 days).
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.
次要结局
- Correlation Between Snapshot NIR Tissue Oxygen Saturation (StO₂) and Intraoperative Reconstructive Strategy(Intraoperative.)
研究者
Valentina Hartwig
Research Scientist
National Research Council, Institute of Clinical Physiology, Italy