Actively Recruiting
Study Evaluating Near-infrared Imaging Coupled With Indocyanine Green for Intraoperative Control of Resection Margins in ENT Surgery
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2025-11-26
65
Participants Needed
2
Research Sites
306 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Study Evaluating Near-infrared Imaging Coupled With Indocyanine Green for Intraoperative Control of Resection Margins in ENT Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years of age or older
- ECOG performance status 0-2
- Histological confirmation of squamous cell carcinoma
- Primary tumour located in the oral cavity or oropharynx
- Disease operable for complete resection
- Negative serum or urinary pregnancy test within 14 days prior to indocyanine green injection for women of childbearing age
- Patient information and signed free and informed consent
- Patient affiliated with a social security or similar scheme
- Ability and willingness to comply with study visits and procedures
You will not qualify if you...
- 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 on pre-operative imaging
- History of invasive cancer unless no recurrence for more than 5 years, except non-melanoma skin cancers
- Pregnant or nursing woman
- Allergy or hypersensitivity to indocyanine green, iodized products, or crustaceans
- Hyperthyroidism, thyroid adenoma, or autoimmune goiter
- Documented coronary artery disease
- Advanced renal failure (creatinine > 1.5mg/dL)
- Use of medications affecting indocyanine green extinction within 2 weeks prior to inclusion
- Patient under guardianship or unable to give consent
- Patients unable to undergo medical follow-up of the trial
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Institut Jules Bordet
Anderlecht, Belgium, 1070
Actively Recruiting
2
Gustave Roussy
Villejuif, Val De Marne, France, 94800
Actively Recruiting
Research Team
P
Philippe Gorphe, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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