- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04842162
Study Evaluating Near-infrared Imaging Coupled With Indocyanin Green for Intraoperative Control of Resection Margins in ENT Surgery (MAGNOLIA)
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Philippe Gorphe, MD
- Phone Number: +33 0142114211
- Email: philippe.gorphe@gustaveroussy.fr
Study Locations
-
-
Val De Marne
-
Villejuif, Val De Marne, France, 94800
- Recruiting
- Gustave Roussy
-
Contact:
- Philippe Gorphe, MD
- Phone Number: +33 0142114211
- Email: philippe.gorphe@gustaveroussy.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients with head and neck cancer
|
indocyanine green (INFRACYANINE© 25mg/10mL.[SERB
- 40, avenue George V - 75008 Paris, France]).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity of Near Infrared Fluorescence Imaging
Time Frame: at surgery
|
Sensitivity of real-time near-infrared fluorescence imaging to detect microscopic residual disease in the operating room after complete macroscopic surgical resection. For the calculation of the sensitivity, for each operating room we consider the first section and the last section in which the pathological analysis confirms the presence of microscopic residual disease. Patients for whom near-infrared fluorescence imaging detects disease are classified as true positives (TP). Sensitivity is defined as the number of TP divided by the total number of patients N. |
at surgery
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-002442-20
- 2019/2886 (Other Identifier: CSET number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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