Organizational Governance of Emerging Technologies: AI Adoption in Healthcare

Private and public sector structures and norms refine how emerging technology is used in practice. In healthcare, despite a proliferation of AI adoption, the organizational governance surrounding its use and integration is often poorly understood. What the Health AI Partnership (HAIP) aims to do in this research is to better define the requirements for adequate organizational governance of AI systems in healthcare settings and support health system leaders to make more informed decisions around AI adoption. To work towards this understanding, we first identify how the standards for the AI adoption in healthcare may be designed to be used easily and efficiently. Then, we map out the precise decision points involved in the practical institutional adoption of AI technology within specific health systems. Practically, we achieve this through a multi-organizational collaboration with leaders from major health systems across the United States and key informants from related fields. Working with the consultancy IDEO.org, we were able to conduct usability-testing sessions with healthcare and AI ethics professionals. Usability analysis revealed a prototype structured around mock key decision points that align with how organizational leaders approach technology adoption. Concurrently, we conducted semi-structured interviews with 89 professionals in healthcare and other relevant fields. Using a modified grounded theory approach, we were able to identify 8 key decision points and comprehensive procedures throughout the AI adoption lifecycle. This is one of the most detailed qualitative analyses to date of the current governance structures and processes involved in AI adoption by health systems in the United States. We hope these findings can inform future efforts to build capabilities to promote the safe, effective, and responsible adoption of emerging technologies in healthcare

Detection of visually occult metastatic lymph nodes using molecularly targeted fluorescent imaging during surgical resection of pancreatic cancer

Background: Although most patients with PDAC experience distant failure after resection, a significant portion still present with local recurrence. Intraoperative fluorescent imaging can potentially facilitate the visualization of involved peritumoral LNs and guide the locoregional extent of nodal dissection. Here, the efficacy of targeted intraoperative fluorescent imaging was examined in the detection of metastatic lymph nodes (LNs) during resection of pancreatic ductal adenocarcinoma (PDAC). Methods: A dose-escalation prospective study was performed to assess feasibility of tumor detection within peripancreatic LNs using cetuximab-IRDye800 in PDAC patients. Fluorescent imaging of dissected LNs was analyzed ex vivo macroscopically and microscopically and fluorescence was correlated with histopathology. Results: A total of 144 LNs (72 in the low-dose and 72 in the high-dose cohort) were evaluated. Detection of metastatic LNs by fluorescence was better in the low-dose (50 mg) cohort, where sensitivity and specificity was 100% and 78% macroscopically, and 91% and 66% microscopically. More importantly, this method was able to detect occult foci of tumor (measuring < 5 mm) with a sensitivity of 88% (15/17 LNs). Conclusion: This study provides proof of concept that intraoperative fluorescent imaging with cetuximab-IRDye800 can facilitate the detection of peripancreatic lymph nodes often containing subclinical foci of disease

First-in-human intraoperative near-infrared fluorescence imaging of glioblastoma using cetuximab-IRDye800

IntroductionMaximizing extent of surgical resection with the least morbidity remains critical for survival in glioblastoma patients, and we hypothesize that it can be improved by enhancements in intraoperative tumor detection. In a clinical study, we determined if therapeutic antibodies could be repurposed for intraoperative imaging during resection.MethodsFluorescently labeled cetuximab-IRDye800 was systemically administered to three patients 2&nbsp;days prior to surgery. Near-infrared fluorescence imaging of tumor and histologically negative peri-tumoral tissue was performed intraoperatively and ex vivo. Fluorescence was measured as mean fluorescence intensity (MFI), and tumor-to-background ratios (TBRs) were calculated by comparing MFIs of tumor and histologically uninvolved tissue.ResultsThe mean TBR was significantly higher in tumor tissue of contrast-enhancing (CE) tumors on preoperative imaging (4.0 ± 0.5) compared to non-CE tumors (1.2 ± 0.3; p = 0.02). The TBR was higher at a 100&nbsp;mg dose than at 50&nbsp;mg (4.3 vs. 3.6). The smallest detectable tumor volume in a closed-field setting was 70&nbsp;mg with 50&nbsp;mg of dye and 10&nbsp;mg with 100&nbsp;mg. On sections of paraffin embedded tissues, fluorescence positively correlated with histological evidence of tumor. Sensitivity and specificity of tumor fluorescence for viable tumor detection was calculated and fluorescence was found to be highly sensitive (73.0% for 50&nbsp;mg dose, 98.2% for 100&nbsp;mg dose) and specific (66.3% for 50&nbsp;mg dose, 69.8% for 100&nbsp;mg dose) for viable tumor tissue in CE tumors while normal peri-tumoral tissue showed minimal fluorescence.ConclusionThis first-in-human study demonstrates the feasibility and safety of antibody based imaging for CE glioblastomas

Intraoperative Pancreatic Cancer Detection using Tumor-Specific Multimodality Molecular Imaging

Background: Operative management of pancreatic ductal adenocarcinoma (PDAC) is complicated by several key decisions during the procedure. Identification of metastatic disease at the outset and, when none is found, complete (R0) resection of primary tumor are key to optimizing clinical outcomes. The use of tumor-targeted molecular imaging, based on photoacoustic and fluorescence optical imaging, can provide crucial information to the surgeon. The first-in-human use of multimodality molecular imaging for intraoperative detection of pancreatic cancer is reported using cetuximab-IRDye800, a near-infrared fluorescent agent that binds to epidermal growth factor receptor. Methods: A dose-escalation study was performed to assess safety and feasibility of targeting and identifying PDAC in a tumor-specific manner using cetuximab-IRDye800 in patients undergoing surgical resection for pancreatic cancer. Patients received a loading dose of 100 mg of unlabeled cetuximab before infusion of cetuximab-IRDye800 (50 mg or 100 mg). Multi-instrument fluorescence imaging was performed throughout the surgery in addition to fluorescence and photoacoustic imaging ex vivo. Results: Seven patients with resectable pancreatic masses suspected to be PDAC were enrolled in this study. Fluorescence imaging successfully identified tumor with a significantly higher mean fluorescence intensity in the tumor (0.09 ± 0.06) versus surrounding normal pancreatic tissue (0.02 ± 0.01), and pancreatitis (0.04 ± 0.01; p < 0.001), with a sensitivity of 96.1% and specificity of 67.0%. The mean photoacoustic signal in the tumor site was 3.7-fold higher than surrounding tissue. Conclusions: The safety and feasibilty of intraoperative, tumor-specific detection of PDAC using cetuximab-IRDye800 with multimodal molecular imaging of the primary tumor and metastases was demonstrated