Last reviewed · How we verify

NCT05499065: LIGHTNING

Real-time Margin Assessment in Head and Neck Cancer

Completed Phase 2 Last updated 31 May 2025
What this trial tests

Phase 2 trial testing Fluorescence guided detection of tumor positive margins in Head and Neck Cancer in 23 participants. Completed in 10 January 2025.

Timeline
1 March 2023
Primary endpoint
23 October 2024
10 January 2025

Quick facts

Lead sponsorUniversity Medical Center Groningen
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment23
Start date1 March 2023
Primary completion23 October 2024
Estimated completion10 January 2025
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

University Medical Center Groningen

Who can join

18 and older, any sex, with Head and Neck Cancer or Head and Neck Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To investigate if the combination of fresh frozen sectioning based on cetuximab-800CW can enhance tumor-positive margin detection intra-operatively.

Publications & conference data

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

  1. 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
  2. Systematic comparison of fluorescence imaging in the near-infrared and shortwave-infrared spectral range using clinical tumor samples containing cetuximab-IRDye800CW.
    Keizers B, Nijboer TS, van der Fels CAM, van den Heuvel MC, et al · · 2025 · cited 7× · PMID 39553388 · DOI 10.1117/1.jbo.30.s1.s13708
  3. Increasing the Dye Payload of Cetuximab-IRDye800CW Enables Photodynamic Therapy.
    Nguyen A, Bhandari C, Keown M, Malkoochi A, et al · · 2024 · cited 6× · PMID 38861020 · DOI 10.1021/acs.molpharmaceut.4c00046
  4. Intraoperative fluorescence-guided fresh frozen sectioning for margin control in head and neck cancer: phase 2 clinical trial.
    Nijboer TS, Keizers B, Boeve K, Roos D, et al · · 2026 · PMID 41807438 · DOI 10.1038/s41467-026-70264-y
  5. Compatibility of fast tissue clearing with targeted fluorescence imaging and pathology analysis using clinical head and neck cancer biopsies.
    Fakhrolmobasheri A, Nijboer TS, Keizers B, Kooij RM, et al · · 2025 · PMID 41276579 · DOI 10.1038/s41598-025-27809-w

Verify or expand the search:

Other recruiting trials for Head and Neck Cancer

Currently open trials in the same condition.

Other University Medical Center Groningen trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05499065.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing