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NCT05507710: FAFI
Indocyanine Green for Perfusion Assessment of DIEP Flaps
Phase 3 trial testing Near-infrared fluorescence imaging of perfusion in Fat Necrosis in 280 participants. Status unknown.
1 September 2025
Quick facts
| Lead sponsor | Leiden University Medical Center |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 280 |
| Start date | 1 May 2019 |
| Primary completion | 1 September 2025 |
| Estimated completion | 1 October 2025 |
| Sites | 2 locations across Netherlands |
Drugs / interventions tested
- Near-infrared fluorescence imaging of perfusion
Conditions studied
- Fat Necrosis — all drugs for Fat Necrosis →
Sponsor
Leiden University Medical Center
Who can join
18 and older, female only, with Fat Necrosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Currently during DIEP flap reconstruction, the perfusion of the flap is assessed by the clinical view of the surgeon. Identification of demarcated ischemic zones of the DIEP flap could be optimized by using fluorescence imaging with indocyanine green (ICG) in order to lower the rate of fat necrosis. This study evaluates whether intraoperative perfusion assessment with ICG fluorescence imaging causes a lower rate of fat necrosis compared to conventional intraoperative clinical evaluation of DIEP flaps.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Near-infrared fluorescence angiography with indocyanine green for perfusion assessment of DIEP and msTRAM flaps: A Dutch multicenter randomized controlled trial.
Tange FP, Verduijn PS, Sibinga Mulder BG, van Capelle L, et al · · 2023 · cited 10× · PMID 37091505 · DOI 10.1016/j.conctc.2023.101128 -
Establishing reference curves for vital tissue perfusion using quantitative near-infrared fluorescence imaging with indocyanine green.
Tange FP, Peul RC, van den Hoven P, Koning S, et al · · 2025 · cited 2× · PMID 39777554 · DOI 10.1007/s00423-024-03589-1
Verify or expand the search:
- PubMed search for NCT05507710
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT05507710 (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 Leiden University Medical Center
- Last refreshed: 19 August 2022
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/NCT05507710.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing