Status:
RECRUITING
Study Evaluating Near-infrared Imaging Coupled With Indocyanine Green for Intraoperative Control of Resection Margins in ENT Surgery
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 can...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04842162
Start Date
December 15 2020
End Date
November 1 2026
Last Update
November 26 2025
Active Locations (2)
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1
Institut Jules Bordet
Anderlecht, Belgium, 1070
2
Gustave Roussy
Villejuif, Val De Marne, France, 94800