NCT03913806: FLASH

FLuoresence Image Guided Surgery With A VEGF-targeted Tracer in Soft-tissue Sarcomas in Humans Approach With Bevacizumab-IRDye 800CW

Completed Phase 1, PHASE2 Last updated 28 January 2020

What this trial tests

Phase 1, PHASE2 trial testing Bevacizumab-IRDye800CW in Soft Tissue Sarcoma in 16 participants. Completed in 1 January 2020.

Timeline

1 May 2018

Primary endpoint
22 December 2019

1 January 2020

Quick facts

Lead sponsor	University Medical Center Groningen
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	16
Start date	1 May 2018
Primary completion	22 December 2019
Estimated completion	1 January 2020
Sites	1 location across Netherlands

Drugs / interventions tested

• Bevacizumab-IRDye800CW — full drug profile →

Conditions studied

• Soft Tissue Sarcoma — all drugs for Soft Tissue Sarcoma →

Sponsor

University Medical Center Groningen

Who can join

18 and older, any sex, with Soft Tissue Sarcoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

There is a need for better visualization of resection margins during surgery for soft tissue sarcoma. Optical molecular imaging of soft tissue sarcoma associated biomarkers is a promising technique to accommodate this need. The biomarker Vascular Endothelial Growth Factor (VEGF-A) is overexpressed in soft tissue sarcoma 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 soft tissue sarcoma visualization using a NIR intraoperative camera system. In this pilot intervention study the investigators will determine the optimal dosage of bevacizumab-800CW (10, 25 or 50mg) to detect soft tissue sarcoma intraoperatively.

Publications & conference data

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

1. Fluorescence Image-Guided Surgery - a Perspective on Contrast Agent Development.
   Barth CW, Gibbs SL. · · 2020 · cited 79× · PMID 32255887 · DOI 10.1117/12.2545292
2. Image-guided surgery and novel intraoperative devices for enhanced visualisation in general and paediatric surgery: a review.
   Privitera L, Paraboschi I, Dixit D, Arthurs OJ, et al · · 2021 · cited 20× · PMID 35937852 · DOI 10.1515/iss-2021-0028
3. Monoclonal Antibodies for Targeted Fluorescence-Guided Surgery: A Review of Applicability across Multiple Solid Tumors.
   Giuliani S, Paraboschi I, McNair A, Smith M, et al · · 2024 · cited 14× · PMID 38473402 · DOI 10.3390/cancers16051045
4. Candidate Biomarkers for Specific Intraoperative Near-Infrared Imaging of Soft Tissue Sarcomas: A Systematic Review.
   Rijs Z, Shifai AN, Bosma SE, Kuppen PJK, et al · · 2021 · cited 12× · PMID 33535618 · DOI 10.3390/cancers13030557
5. Detection by fluorescence of pituitary neuroendocrine tumour (PitNET) tissue during endoscopic transsphenoidal surgery using bevacizumab-800CW (DEPARTURE trial): study protocol for a non-randomised, non-blinded, single centre, feasibility and dose-finding trial.
   Vergeer RA, Postma MR, Schmidt I, Korsten-Meijer AG, et al · · 2021 · cited 6× · PMID 34620658 · DOI 10.1136/bmjopen-2021-049109
6. CORR Insights®: What Are the Complication Rates and Factors Associated With Total Femur Replacement After Tumor Resection? Findings From the Japanese Musculoskeletal Oncology Group.
   Damron TA. · · 2024 · PMID 37938137 · DOI 10.1097/corr.0000000000002915