NCT02743975: PENGUIN

Near-infrared Image Guided Surgery in Pancreatic Adenocarcinoma

Terminated Phase 1, PHASE2 Last updated 28 January 2020

What this trial tests

Phase 1, PHASE2 trial testing Bevacizumab-800CW in Pancreatic Cancer in 10 participants. Terminated before completion.

Timeline

1 December 2016

Primary endpoint
26 February 2018

1 May 2018

Quick facts

Lead sponsor	University Medical Center Groningen
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	10
Start date	1 December 2016
Primary completion	26 February 2018
Estimated completion	1 May 2018
Sites	3 locations across Netherlands

Drugs / interventions tested

• Bevacizumab-800CW — full drug profile →

Conditions studied

• Pancreatic Cancer — all drugs for Pancreatic Cancer →
• Pancreatic Adenocarcinoma — all drugs for Pancreatic Adenocarcinoma →

Sponsor

University Medical Center Groningen

Who can join

18 and older, any sex, with Pancreatic Cancer or Pancreatic Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

There is a need for better visualization of resection margins and detection of small tumor deposits during surgery for pancreatic cancer. Optical molecular imaging of pancreatic ductal adenocarcinoma associated biomarkers is a promising technique to accommodate this need. The biomarker Vascular Endothelial Growth Factor (VEGF-A) is overexpressed in pancreatic cancer tissue versus normal tissue and has proven to be a valid target for molecular imaging. VEGF-A can be targeted by the monoclonal antibody bevacizumab. Monoclonal antibodies can be labeled by the near-infrared (NIR) fluorescent dye IRDye800CW (800CW). The investigators hypothesize that bevacizumab-800CW accumulates in VEGF expressing cancer, enabling pancreatic cancer visualization using a NIR intraoperative camera system. In this pilot intervention study the investigators will determine the optimal dosage of bevacizumab-800CW (4,5 10, 25 or 50mg) to detect pancreatic cancer tissue intraoperatively.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. A practical guide for the use of indocyanine green and methylene blue in fluorescence-guided abdominal surgery.
   van Manen L, Handgraaf HJM, Diana M, Dijkstra J, et al · · 2018 · cited 214× · PMID 29938401 · DOI 10.1002/jso.25105
2. Oncologic Procedures Amenable to Fluorescence-guided Surgery.
   Tipirneni KE, Warram JM, Moore LS, Prince AC, et al · · 2017 · cited 116× · PMID 28045715 · DOI 10.1097/sla.0000000000002127
3. Fluorescence Image-Guided Surgery - a Perspective on Contrast Agent Development.
   Barth CW, Gibbs SL. · · 2020 · cited 79× · PMID 32255887 · DOI 10.1117/12.2545292
4. Targeted Optical Imaging Agents in Cancer: Focus on Clinical Applications.
   Joshi BP, Wang TD. · · 2018 · cited 63× · PMID 30224903 · DOI 10.1155/2018/2015237
5. Role of the Tumor Microenvironment in Regulating Pancreatic Cancer Therapy Resistance.
   Deng D, Patel R, Chiang CY, Hou P. · · 2022 · cited 37× · PMID 36230914 · DOI 10.3390/cells11192952
6. Optical Surgical Navigation for Precision in Tumor Resections.
   Harmsen S, Teraphongphom N, Tweedle MF, Basilion JP, et al · · 2017 · cited 30× · PMID 28271367 · DOI 10.1007/s11307-017-1054-1
7. Fluorescent-guided surgery for sentinel lymph node detection in gastric cancer and carcinoembryonic antigen targeted fluorescent-guided surgery in colorectal and pancreatic cancer.
   Vuijk FA, Hilling DE, Mieog JSD, Vahrmeijer AL. · · 2018 · cited 26× · PMID 30216455 · DOI 10.1002/jso.25139
8. Advantages of patient-derived orthotopic mouse models and genetic reporters for developing fluorescence-guided surgery.
   Lwin TM, Hoffman RM, Bouvet M. · · 2018 · cited 25× · PMID 30080930 · DOI 10.1002/jso.25150