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NCT05499065: LIGHTNING
Real-time Margin Assessment in Head and Neck Cancer
Phase 2 trial testing Fluorescence guided detection of tumor positive margins in Head and Neck Cancer in 23 participants. Completed in 10 January 2025.
23 October 2024
Quick facts
| Lead sponsor | University Medical Center Groningen |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 23 |
| Start date | 1 March 2023 |
| Primary completion | 23 October 2024 |
| Estimated completion | 10 January 2025 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Fluorescence guided detection of tumor positive margins
- Cetuximab-IRDye800 — full drug profile →
Conditions studied
- Head and Neck Cancer — all drugs for Head and Neck Cancer →
- Head and Neck Squamous Cell Carcinoma — all drugs for Head and Neck Squamous Cell Carcinoma →
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):
-
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT05499065
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07209189 — Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-esca · Phase 2 · recruiting
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Other University Medical Center Groningen trials
Trials by the same sponsor.
- NCT06647602 — Thyroid Hormone Replacement After Radio Iodine: Value and Efficacy · not yet recruiting
- NCT06809946 — Feasibility of Fluorescence Imaging With Bevacizumab-800CW During Bronchoscopy · Phase 2 · not yet recruiting
- NCT07527390 — CANagliflozin In DIALysis Patients · Phase 4 · not yet recruiting
- NCT07439237 — Implant-supported Maxillary Overdentures; a 15-years Evaluation · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05499065 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Medical Center Groningen
- Last refreshed: 31 May 2025
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