A study of VGT-309 fluorescence imaging during surgery for pancreatic and periampullary cancer

Participants will receive a single intravenous infusion of VGT-309 (abenacianine) at a dose of 0.31 mg/kg, expressed as abenacianine sodium free equivalent. VGT-309 will be prepared and administered by appropriately trained authorised clinical or research staff in a hospital setting in accordance with the Investigator's Brochure and institutional procedures. Participants will be monitored during the infusion and for an appropriate period afterwards in accordance with standard hospital procedures. The start and completion time of the infusion will be recorded for each participant. The duration of the infusion is not fixed by the study protocol and will follow the administration requirements specified in the Investigator's Brochure and institutional procedures. VGT-309 will be administered 12–96 hours before surgery. The administration time selected for each participant will be documented and evaluated as part of the study feasibility outcomes. The dose will remain unchanged throughout the study. This administration window is based on previous clinical studies of VGT-309, which demonstrated suitable visualisation following administration 12-96 hours before surgery. Participants will undergo their planned curative-intent pancreatic or periampullary cancer surgery according to standard clinical care. The surgical procedure, anaesthesia, diagnostic laparoscopy where clinically indicated, tumour mobilisation and resection, lymph node resection, and routine perioperative care are not study-specific interventions and would occur irrespective of study participation. The study-specific imaging component consists of near-infrared (NIR) fluorescence imaging after VGT-309 administration. It is incorporated into the planned surgical procedure at predefined stages and supplements conventional white-light visual assessment and surgical judgement. It is not a standalone surgical procedure and does not replace standard surgical assessment. At each applicable intraoperative assessment point, the operating surgeon will first assess the relevant surgical field using conventional white-light visualisation. Where practicable, this assessment will be completed before the fluorescence image is reviewed. NIR fluorescence imaging will then be performed using a commercially available NIR imaging system compatible with VGT-309. Representative white-light and fluorescence photographs or video may also be recorded. The following assessments will occur where clinically applicable: 1. Diagnostic laparoscopy: Before commencement of the planned resection, the operating surgeon will assess the peritoneal cavity, liver surfaces, upper abdomen, pelvis, and other accessible regions using standard white-light visualisation followed by NIR fluorescence imaging. Any suspicious lesion may undergo further investigation or biopsy according to routine clinical practice. 2. Tumour localisation and mobilisation: After the pancreas has been exposed, the operating surgeon will assess the primary tumour using white-light and NIR fluorescence imaging before and during tumour mobilisation to assess tumour localisation and delineation. 3. Tumour resection and margin assessment: During and following tumour resection, the operating surgeon will use NIR fluorescence imaging to assess the operative field and resection margins for fluorescence, including residual fluorescence where present. 4. Lymph node assessment: Where regional lymph nodes are identified during surgery, the operating surgeon may assess these using NIR fluorescence imaging before their routine resection. 5. Surgical specimen assessment: After the specimen has been surgically removed and before routine pathological processing, the resected specimen will undergo ex vivo white-light and NIR fluorescence imaging. This assessment evaluates fluorescence in the primary tumour, resection margins, lymph nodes where applicable, and any additional resected tissue. Specimen imaging does not alter routine specimen handling, orientation, or pathological processing. Each NIR fluorescence imaging assessment is expected to take approximately 5 minutes or less, although the exact duration may vary according to the surgical procedure, intraoperative findings, and whether additional photographs or video are acquired. Up to five NIR fluorescence imaging assessments may be performed during the operation, where clinically applicable. The total additional time associated with NIR fluorescence imaging is therefore expected to be approximately 25 minutes or less across the surgical procedure. These assessments are incorporated at the relevant stages of the planned operation rather than performed as a separate continuous procedure. The underlying surgical activities, including diagnostic laparoscopy, tumour mobilisation, tumour resection, margin assessment, and lymph node resection, form part of standard clinical care and are not included in this estimated additional imaging time. The overall duration of surgery will be recorded as a study outcome. Following specimen imaging, all resected tissue will undergo routine histopathological examination according to standard institutional pathology procedures. Histopathology is part of usual clinical care and is not a comparator intervention or study-specific treatment. It will confirm the final diagnosis and assess tumour type, size, grade, pathological stage, resection margin status, lymph node involvement, treatment response where applicable, and metastatic disease. Histopathological findings will subsequently be correlated with the intraoperative and ex vivo fluorescence findings and will serve as the reference standard for confirmation of malignant tissue. Intervention adherence will be assessed through documentation of the VGT-309 dose and administration timing, completion of the planned fluorescence imaging assessments, and any deviations from the protocol in the study records and case report forms.