Informations générales (source: ClinicalTrials.gov)
Study Evaluating Near-infrared Imaging Coupled With Indocyanine Green for Intraoperative Control of Resection Margins in ENT Surgery
Interventional
Phase 2
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
décembre 2020
novembre 2026
05 septembre 2025
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
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | PHILIPPE GORPHE | 27/03/2024 16:04:15 | Contacter | ||
Critères
Tous
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
- 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
- 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