Using near-infrared imaging with indocyanine green to improve surgery for head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of near-infrared fluorescence imaging combined with indocyanine green to identify microscopic residual cancer during surgery for head and neck cancers. The approach aims to enhance the precision of surgical resections by providing real-time feedback on the presence of cancerous tissue. Patients undergoing surgery for operable squamous cell carcinoma in the oral cavity or oropharynx will receive indocyanine green prior to their procedure. The goal is to ensure complete removal of cancerous tissue and minimize the risk of recurrence.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female 18 years of age or older
* ECOG performance status 0-2
* Histological confirmation of squamous cell carcinoma
* Locating the primary tumour in the oral cavity or oropharynx
* Disease operable for complete resection
* Serum or urinary pregnancy test (as per centre practices) negative within 14 days prior to systemic indocyanin green injection (pre-operative visit), for women of childbearing age
* Patient information and signed free and informed consent
* Patient affiliated with a social security scheme or beneficiary of a similar scheme.
* The patient must understand, sign and date the consent form prior to any protocol-specific procedures. The patient must be able and willing to comply with the study visits and procedures described in the protocol

Exclusion Criteria:

* Severe medical co-morbidities or contraindications to surgery
* Primary tumour not operable
* History of head and neck cancer in the past 5 years
* History of radiation for head and neck cancer
* Metastatic cancer
* Tumours with necrosis ranges in pre-operative imaging
* History of invasive cancer unless there has been no recurrence for more than 5 years with an exception for non-melanoma skin cancers.
* Pregnant or nursing woman
* Allergy or hypersensitivity to the product being administered (its active substance or other ingredients), iodized products or crustaceans.
* Hyperthyroidism, thyroid adenoma, unifocal, multifocal or multinodular goiter of autoimmune origin.
* Documented coronary artery disease
* Advanced renal failure (creatinine \> 1.5mg/dL).
* Within 2 weeks prior to inclusion, concomitant medication that reduces or increases extinction of GI (i.e. anticonvulsants, haloperidol and Heparin).
* Patient under guardianship or curatorship or deprived of liberty by judicial or administrative decision or patient unable to give consent.
* Patients unable to undergo medical follow-up of the trial

Where it's running

• Institut Jules Bordet
  Anderlecht, Belgium Recruiting
• Gustave Roussy
  Villejuif, Val De Marne, France Recruiting

Study contacts

• Study coordinator: Philippe Gorphe, MD
• Email: philippe.gorphe@gustaveroussy.fr
• Phone: +33 (0)1 42 11 42 11

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.