A handheld device for intra-cavity and ex vivo fluorescence imaging of breast conserving surgery margins with 5-aminolevulinic acid.

BACKGROUND: Visualization of cancer during breast conserving surgery (BCS) remains challenging; the BCS reoperation rate is reported to be 20-70% of patients. An urgent clinical need exists for real-time intraoperative visualization of breast carcinomas during BCS. We previously demonstrated the ability of a prototype imaging device to identify breast carcinoma in excised surgical specimens following 5-aminolevulinic acid (5-ALA) administration. However, this prototype device was not designed to image the surgical cavity for remaining carcinoma after the excised lumpectomy specimen is removed. A new handheld fluorescence (FL) imaging prototype device, designed to image both excised specimens and within the surgical cavity, was assessed in a clinical trial to evaluate its clinical utility for first-in-human, real-time intraoperative imaging during index BCS. RESULTS: The imaging device combines consumer-grade imaging sensory technology with miniature light-emitting diodes (LEDs) and multiband optical filtering to capture high-resolution white light (WL) and FL digital images and videos. The technology allows for visualization of protoporphyrin IX (PpIX), which fluoresces red when excited by violet-blue light. To date, n = 17 patients have received 20 mg kg bodyweight (BW) 5-ALA orally 2-4 h before imaging to facilitate the accumulation of PpIX within tumour cells. Tissue types were identified based on their colour appearance. Breast tumours in sectioned lumpectomies appeared red, which contrasted against the green connective tissues and orange-brown adipose tissues. In addition, ductal carcinoma in situ (DCIS) that was missed during intraoperative standard of care was identified at the surgical margin at <1 mm depth. In addition, artifacts due to the surgical drape, illumination, and blood within the surgical cavity were discovered. CONCLUSIONS: This study has demonstrated the detection of a grossly occult positive margin intraoperatively. Artifacts from imaging within the surgical cavity have been identified, and potential mitigations have been proposed. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01837225 (Trial start date is September 2010. It was registered to ClinicalTrials.gov retrospectively on April 23, 2013, then later updated on April 9, 2020, to reflect the introduction of the new imaging device.).

Intraoperative fluorescence imaging with aminolevulinic acid detects grossly occult breast cancer: a phase II randomized controlled trial.

BACKGROUND: Re-excision due to positive margins following breast-conserving surgery (BCS) negatively affects patient outcomes and healthcare costs. The inability to visualize margin involvement is a significant challenge in BCS. 5-Aminolevulinic acid hydrochloride (5-ALA HCl), a non-fluorescent oral prodrug, causes intracellular accumulation of fluorescent porphyrins in cancer cells. This single-center Phase II randomized controlled trial evaluated the safety, feasibility, and diagnostic accuracy of a prototype handheld fluorescence imaging device plus 5-ALA for intraoperative visualization of invasive breast carcinomas during BCS. METHODS: Fifty-four patients were enrolled and randomized to receive no 5-ALA or oral 5-ALA HCl (15 or 30 mg/kg). Forty-five patients (n = 15/group) were included in the analysis. Fluorescence imaging of the excised surgical specimen was performed, and biopsies were collected from within and outside the clinically demarcated tumor border of the gross specimen for blinded histopathology. RESULTS: In the absence of 5-ALA, tissue autofluorescence imaging lacked tumor-specific fluorescent contrast. Both 5-ALA doses caused bright red tumor fluorescence, with improved visualization of tumor contrasted against normal tissue autofluorescence. In the 15 mg/kg 5-ALA group, the positive predictive value (PPV) for detecting breast cancer inside and outside the grossly demarcated tumor border was 100.0% and 55.6%, respectively. In the 30 mg/kg 5-ALA group, the PPV was 100.0% and 50.0% inside and outside the demarcated tumor border, respectively. No adverse events were observed, and clinical feasibility of this imaging device-5-ALA combination approach was confirmed. CONCLUSIONS: This is the first known clinical report of visualization of 5-ALA-induced fluorescence in invasive breast carcinoma using a real-time handheld intraoperative fluorescence imaging device. TRIAL REGISTRATION: Clinicaltrials.gov identifier NCT01837225 . Registered 23 April 2013.

Hidradenitis Suppurativa: A Frequently Missed Diagnosis, Part 2: Treatment Options.

Hidradenitis suppurativa (HS) is a chronic inflammatory disorder of the intertriginous area. Patients with HS have several challenges to their quality of life and activities of everyday living, including malodor, purulent discharge, and discomfort. There is often a delay in diagnosis and appropriate treatment. The need for cosmetically acceptable local treatments and dressing application makes this disease an important challenge for wound care specialists. The choice of optimal treatment varies depending on the disease severity, expert knowledge, the availability of an interprofessional team, and patient factors.

Hidradenitis Suppurativa: A Frequently Missed Diagnosis, Part 1: A Review of Pathogenesis, Associations, and Clinical Features.

PURPOSE: To provide information about the etiology, diagnostic evaluations, and clinical features of hidradenitis suppurativa (HS). TARGET AUDIENCE: This continuing education activity is intended for physicians and nurses with an interest in skin and wound care. OBJECTIVES: After participating in this educational activity, the participant should be better able to:1. Identify the prevalence, pathophysiology, and risk factors associated with HS.2. Describe diagnostic evaluations, staging, and comorbid disorders associated with HS. Hidradenitis Suppurativa (HS) is a recurrent inflammatory follicular disease that commonly affects the apocrine-bearing skin. The aim of this continuing education article is to review the pathogenesis and clinical presentations of HS. The spectrum of clinical presentations ranges from subcutaneous nodules to draining sinus and fistula. The pathogenesis of HS remains unknown.

Beyond adolescence exploring Canadian women and men's perception of overweight.

PURPOSE: The research literature strongly corroborates that desires and attempts to lose weight are more prevalent among women who are already within the healthy weight range than men. The development of a distorted weight perception, specifically an overestimation of one's body size, may manifest into caloric restriction and other disordered eating behaviors. However, there is no systematic process to monitor the prevalence of disordered eating behaviors in Canada. The objective of this study was to investigate the prevalence and the sociodemographic characteristics of Canadian adults who have a perception of being overweight when their body mass index indicates that they are normal or underweight based on self-reported heights and weights. METHODS: The responses to the 2000/2001 Canadian Community Health Survey by a representative sample of Canadians between the ages of 20 and 64 were analyzed. Bivariate and logistic regression analyses were performed. RESULTS: The prevalence of perceiving oneself as overweight when at acceptable weight for height was 23.6% for women and 7.8% for men. The probability was significantly greater in women, some foreign-born residents, those with a higher income level, and with increasing age. CONCLUSIONS: These results suggest that, in contrast to mainstream thinking, distorted weight perception is experienced by adult and aging women, and not only by adolescent girls. More research is needed to understand why distorted weight perception increases with age in women and what potential adverse effects it may have in this population.