Using near-infrared imaging with indocyanine green to improve surgery for head and neck cancer
Study Evaluating Near-infrared Imaging Coupled With Indocyanine Green for Intraoperative Control of Resection Margins in ENT Surgery
This study is testing if a special imaging technique using a dye can help doctors find and remove all the cancer during surgery for patients with head and neck cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gustave Roussy, Cancer Campus, Grand Paris Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Anderlecht and 1 other locations) |
| Trial ID | NCT04842162 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with operable squamous cell carcinoma located in the oral cavity or oropharynx.
Not a fit: Patients with severe medical co-morbidities, inoperable tumors, or a history of head and neck cancer within the past five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could lead to more effective surgeries and better outcomes for patients with head and neck cancer.
How similar studies have performed: Other studies have shown promise in using imaging techniques for surgical guidance, but this specific combination of near-infrared imaging and indocyanine green is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Anderlecht and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.