Study Evaluating Near-infrared Imaging Coupled With Indocyanine Green for Intraoperative Control of Resection Margins in ENT Surgery
Overview
- Phase
- Phase 2
- Intervention
- indocyanine green
- Conditions
- Head and Neck Cancer
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Enrollment
- 65
- Locations
- 2
- Primary Endpoint
- Sensitivity of Near Infrared Fluorescence Imaging
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
Assess the sensitivity of real-time near-infrared fluorescence imaging to detect microscopic residual disease in the operating room after a complete macroscopic surgical resection of head and neck cancers
Investigators
Eligibility 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.
Arms & Interventions
Patients with head and neck cancer
Intervention: indocyanine green
Outcomes
Primary Outcomes
Sensitivity of Near Infrared Fluorescence Imaging
Time Frame: at surgery
Sensitivity of real-time near-infrared fluorescence imaging to detect microscopic residual disease in the operating room after complete macroscopic surgical resection. For the calculation of the sensitivity, for each operating room we consider the first section and the last section in which the pathological analysis confirms the presence of microscopic residual disease. Patients for whom near-infrared fluorescence imaging detects disease are classified as true positives (TP). Sensitivity is defined as the number of TP divided by the total number of patients N.