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FLUOPANC-trial - Fluorescence-guided Surgery of Pancreatic and Bileduct Tumors Using cRGD-ZW800-1

NCT05518071 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-06-24

No results posted yet for this study

Summary

Pancreas as well as Cholangiocarcinoma have a dismal prognosis at time of diagnosis, due to late onset of clinical symptoms, patients present with advance disease. Complete surgical resection is the only potential curative treatment, however only a small percentage is eligible for upfront total surgical resection due to extension into anatomical related important vascular structures. Neoadjuvant chemo(radio)therapy has become the standard treatment modality for non-primary resectable disease (borderline resectable and locally advanced pancreatic cancer (LAPC)), where subsequent downstaging can make identification of the primary tumor more challenging during surgery. Near-infrared (NIR) fluorescence imaging can aid surgeons by providing real-time visualization of tumors, suspect lymph nodes and vital structures during surgery. Additional intra-operative feedback could possibly reduce the frequency of positive resection margins and increase complete removal of locally spread tumor and involved lymph nodes and could thereby improve patient outcomes as well as overall survival. cRGD-ZW800-1 is a targeted NIR-fluorophore, with specific binding capacity for integrins (αvβ3, αvβ5, αvβ6) which are overexpressed on tumor cells and tumor-associated vascular endothelium associated with neoangiogenesis.

Conditions

Interventions

DRUG

CRGD-ZW800-1

Intravenous single bolus injection of the targeted NIR fluorophore cRGD-ZW800-1. This targeted 800nm zwitterionic fluorophore developed by the Hospital Pharmacy Department of LUMC consists of the fluorophore ZW800-1 conjugated to the cRGD peptide

DEVICE

Intraoperative near-infrared fluorescence imaging

Intraoperative imaging will be performed with at least one of the following CE-marked near-infrared (NIR) fluorescence imaging systems: Quest Spectrum imaging platform (v2/3.0) for open-procedures, the Olympus or Karl-Storz system for the diagnostic laparoscopy or the Intuitive Surgical Da Vinci Xi (Firefly-mode) for minimally invasive robot-assisted procedures. With a NIR-imaging system a potential fluorescent signal of the tumor can be evaluated. Furthermore, the Quest Spectrum platform will also be used for evaluation of ex-vivo fluorescence of resected tissue on the back table (Back table imaging) and pathology department (ex-vivo imaging), which shall be performed during and after every procedure.

Sponsors & Collaborators

  • Leiden University Medical Center

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-09
Primary Completion
2024-05-23
Completion
2024-05-23
FDA Device
Yes

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05518071 on ClinicalTrials.gov