NCT02920216: SALVADS-Fluo

Interest of Fluorescence in Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area

Completed NA Last updated 31 March 2022

What this trial tests

NA trial testing indocyanine green in Head and Neck Cancer in 10 participants. Completed in 6 September 2017.

Timeline

6 December 2016

Primary endpoint
10 August 2017

6 September 2017

Quick facts

Lead sponsor	Institut de Cancérologie de Lorraine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	10
Start date	6 December 2016
Primary completion	10 August 2017
Estimated completion	6 September 2017
Sites	1 location across France

Drugs / interventions tested

• indocyanine green (INDOCYANINE GREEN) — full drug profile →

Conditions studied

• Head and Neck Cancer — all drugs for Head and Neck Cancer →

Sponsor

Institut de Cancérologie de Lorraine — full company profile →

Who can join

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

Sponsor's own description

Treatment of Head and Neck Squamous cell carcinoma often combines chemoradiotherapy when organ has to be preserved or when surgery is not indicated. The loco-regional failure is about 30%. Then salvage surgery is the only chance for patients to survive but the overall survival rate is only 29% at 24 months. This prognostic is bad because of poor local control which is non-optimized by a complementary radiotherapy and negative exeresis margins.

Currently, there is no intraoperative technique to better visualize the tumor limits in real time. With fluorescence techniques, an accurate mapping of tumor extension can be considered. Recently, Atallah et al. (2015) demonstrated the use of fluorescence during a head and neck surgery in mice, as a tool allowing for better surgical margins. Digonnet et al (2015) found a tumor fragment after an injection of indocyanine green (ICG) intravenously in salvage surgery for patient with head and neck cancer.

The ability of ICG to detect a surgical margin positive intraoperatively has never be evaluated in irradiated area.

The aim of this pilot study is to evaluate the interest of fluorescence in salvage surgery for recurrence of head and neck cancer in irradiated area.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Recent Developments of ICG-Guided Sentinel Lymph Node Mapping in Oral Cancer.
   Kim JH, Ku M, Yang J, Byeon HK. · · 2021 · cited 25× · PMID 34067713 · DOI 10.3390/diagnostics11050891