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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001037392p
Ethics application status
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Not yet submitted
Date submitted
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7/08/2026
Date registered
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24/08/2026
Date last updated
Help: Date last updated
24/08/2026
Date data sharing statement initially provided
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24/08/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
A study of VGT-309 fluorescence imaging during surgery for pancreatic and periampullary cancer
Scientific title
A prospective feasibility study of VGT-309-guided near-infrared fluorescence imaging for intraoperative tumour visualisation in adults undergoing curative-intent surgery for pancreatic ductal adenocarcinoma or periampullary adenocarcinoma, with the primary outcome of feasibility of integration into the surgical workflow.
Additional trial identifiers [1] 318117 0
Nil
Universal Trial Number (UTN)
Trial acronym
VISION-PANC
Related trial records

Health condition
Health condition(s) studied:
Pancreatic cancer 343159 0
Condition category
Condition code
Cancer 339244 339244 0 0
Pancreatic
Surgery 339349 339349 0 0
Other surgery
Surgery 339350 339350 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
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.
Intervention code [1] 335001 0
Treatment: Surgery
Intervention code [2] 335002 0
Diagnosis / Prognosis
Description of the comparator or control
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346481 0
Feasibility of integrating VGT-309-guided near-infrared fluorescence imaging into pancreatic and periampullary cancer surgery, assessed as a composite feasibility outcome.
Timepoint [1] 346481 0
During the surgical procedure, with the composite feasibility outcome determined following completion of all applicable intraoperative fluorescence imaging assessments and collection of the associated study data.
Secondary outcome [1] 466017 0
Tumour localisation using VGT-309-guided near-infrared fluorescence imaging.
Timepoint [1] 466017 0
During surgery, following exposure of the pancreas and before and during tumour mobilisation.
Secondary outcome [2] 466018 0
Intraoperative fluorescence image quality following VGT-309 administration.
Timepoint [2] 466018 0
During surgery at applicable fluorescence imaging assessments: diagnostic laparoscopy, tumour localisation and mobilisation, tumour resection and margin assessment, lymph node assessment, and surgical specimen assessment.
Secondary outcome [3] 466019 0
Concordance between fluorescence imaging findings and routine histopathological assessment.
Timepoint [3] 466019 0
Following completion of routine histopathological assessment and availability of the final histopathology report after surgery.
Secondary outcome [4] 466366 0
Safety and tolerability of VGT-309, assessed by adverse events and serious adverse events related to VGT-309.
Timepoint [4] 466366 0
From administration of VGT-309 until completion of study participation, including the post-operative hospital stay and follow-up. Adverse events related to VGT-309 will continue to be followed until resolved, stabilised, or another clinically appropriate outcome has been determined by the Investigator.

Eligibility
Key inclusion criteria
Adults aged greater than or equal to 18 years.
Planned curative-intent surgical resection for known or suspected pancreatic ductal adenocarcinoma or periampullary adenocarcinoma (including ampullary, distal bile duct, or duodenal adenocarcinoma).
Considered suitable for curative-intent surgery by the treating multidisciplinary team.
No contraindication to intravenous VGT-309 administration.
Able to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Previous treatment with VGT-309.
Known hypersensitivity or allergy to VGT-309 or any of its excipients.
Pregnancy or breastfeeding.
Any medical condition that, in the opinion of the investigator, would make administration of VGT-309 unsafe.
Participation in another interventional clinical trial that, in the opinion of the investigator, could affect the study outcomes.
Unable or unwilling to provide written informed consent.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 20 participants was selected pragmatically for this prospective, single-arm feasibility study. No formal sample size calculation was performed because the study is designed to evaluate feasibility, imaging performance, safety, and integration of VGT-309-guided fluorescence imaging into the pancreatic surgical workflow, rather than to demonstrate clinical efficacy or detect statistically significant differences.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/01/2027
Actual
Date of last participant enrolment
Anticipated
11/01/2029
Actual
Date of last data collection
Anticipated
11/01/2029
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 29957 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 46321 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 322666 0
Commercial sector/Industry
Name [1] 322666 0
Vergent Bioscience
Country [1] 322666 0
Australia
Primary sponsor type
Hospital
Name
The Jreissati Pancreatic Centre at Epworth
Address
Country
Australia
Secondary sponsor category [1] 325600 0
None
Name [1] 325600 0
Address [1] 325600 0
Country [1] 325600 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 321121 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 321121 0
Ethics committee country [1] 321121 0
Australia
Date submitted for ethics approval [1] 321121 0
14/10/2026
Approval date [1] 321121 0
Ethics approval number [1] 321121 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 152742 0
Mr Julian Choi
Address 152742 0
Epworth HealthCare, 89 Bridge Road, Richmond, Vic, 3121
Country 152742 0
Australia
Phone 152742 0
+61 03 94268880
Fax 152742 0
Email 152742 0
[email protected]
Contact person for public queries
Name 152743 0
Julian Choi
Address 152743 0
Epworth HealthCare, 89 Bridge Road, Richmond, Vic, 3121
Country 152743 0
Australia
Phone 152743 0
+61 03 94268880
Fax 152743 0
Email 152743 0
[email protected]
Contact person for scientific queries
Name 152744 0
Ashleigh Poh
Address 152744 0
Epworth HealthCare, 89 Bridge Road, Richmond, Vic, 3121
Country 152744 0
Australia
Phone 152744 0
+61 03 94268880
Fax 152744 0
Email 152744 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.