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Study evaluating near-infrared imaging coupled with indocyanine green for intraoperative monitoring of resection margins in ENT surgery
EU CTIS ID: 2022-502737-26-00
What this study is testing
To evaluate the sensitivity of real-time near-infrared fluorescence imaging to detect microscopic residual disease in the surgical specimen after complete gross surgical resection of head and neck carcinoma
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female, 18 years of age or older - ECOG performance status 0-2 - Histological confirmation of epidermoid carcinoma - Location of the primary tumor in the oral cavity or oropharynx - Operable disease with the intention of complete resection - Negative serum or urine pregnancy test (depending on the center's practice) within 14 days prior to systemic injection of indocyanine green (pre-operative visit), for women of childbearing potential - informed consent form signed by the patient - Patient affiliated with a social security plan or beneficiary of a similar plan. - Patient must understand, sign and date the informed consent form prior to any protocol specific procedure. Patient must be able and willing to comply with study visits and procedures outlined in the protocol.
You likely can't join if
- Severe medical co-morbidities or contraindications to surgery - Non-operable primary tumor - History of head and neck cancer in the last 5 years - History of radiation treatment for head and neck cancer - Metastatic cancer - Tumors with necrotic areas on preoperative 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 breastfeeding woman - Allergy or hypersensitivity to the administered product (its active substance or other ingredients), to iodized products or to shellfish. - 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 ICG extinction (i.e. anticonvulsants, haloperidol and Heparin). - Patients under guardianship or deprived of liberty by judicial or administrative decision or patients unable to give consent. - Patients unable to comply with the medical follow-up of the trial
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.