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Study Evaluating Near-infrared Imaging Coupled With Indocyanin Green for Intraoperative Control of Resection Margins in ENT Surgery (MAGNOLIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04842162
Recruitment Status : Recruiting
First Posted : April 13, 2021
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Study Description
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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 cancers

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: indocyanine green Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective non-randomized bicentric study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study Evaluating Near-infrared Imaging Coupled With Indocyanin Green for Intraoperative Control of Resection Margins in ENT Surgery
Actual Study Start Date : December 15, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients with head and neck cancer Drug: indocyanine green
indocyanine green (INFRACYANINE© 25mg/10mL.[SERB - 40, avenue George V - 75008 Paris, France]).


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04842162


Contacts
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Contact: Philippe Gorphe, MD 0142114211 ext +33 philippe.gorphe@gustaveroussy.fr

Locations
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France
Gustave Roussy Recruiting
Villejuif, Val De Marne, France, 94800
Contact: Philippe Gorphe, MD    0142114211 ext +33    philippe.gorphe@gustaveroussy.fr   
Contact: Thibaud Motreff    0142114211 ext +33    thibaud.motreff@gustaveroussy.fr   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
More Information
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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT04842162    
Other Study ID Numbers: 2019-002442-20
2019/2886 ( Other Identifier: CSET number )
First Posted: April 13, 2021    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms