Recruiting NCT04842162
Study Evaluating Near-infrared Imaging Coupled With Indocyanine Green for Intraoperative Control of Resection Margins in ENT Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: indocyanine green.
- Who it may be relevant to
- Registry conditions: Head and Neck Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Drug indocyanine green
indocyanine green (INFRACYANINE© 25mg/10mL).
Primary outcome measures
- Sensitivity of Near Infrared Fluorescence Imaging [Time frame: at surgery]
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.
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Belgium · 1 center
- Institut Jules Bordet — Anderlecht
France · 1 center
- Gustave Roussy — Villejuif
Identifiers
NCT: NCT04842162 · 2019-002442-20 · 2019/2886