Back to resultsStudy Evaluating Near-infrared Imaging Coupled With Indocyanin Green for Intraoperative Control of Resection Margins in ENT Surgery (MAGNOLIA)
Primary Purpose
Head and Neck Cancer
Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
indocyanine green
Sponsored by
About this trial
This is an interventional diagnostic trial for Head and Neck Cancer
Eligibility 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
Sites / Locations
- Gustave RoussyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with head and neck cancer
Arm Description
Outcomes
Primary Outcome Measures
Sensitivity of Near Infrared Fluorescence Imaging
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04842162
First Posted
April 8, 2021
Last Updated
April 8, 2021
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
1. Study Identification
Unique Protocol Identification Number
NCT04842162
Brief Title
Study Evaluating Near-infrared Imaging Coupled With Indocyanin Green for Intraoperative Control of Resection Margins in ENT Surgery
Acronym
MAGNOLIA
Official Title
Study Evaluating Near-infrared Imaging Coupled With Indocyanin Green for Intraoperative Control of Resection Margins in ENT Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Prospective non-randomized bicentric study
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with head and neck cancer
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
indocyanine green
Intervention Description
indocyanine green (INFRACYANINE© 25mg/10mL.[SERB - 40, avenue George V - 75008 Paris, France]).
Primary Outcome Measure Information:
Title
Sensitivity of Near Infrared Fluorescence Imaging
Description
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.
Time Frame
at surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe Gorphe, MD
Phone
0142114211
Ext
+33
Email
philippe.gorphe@gustaveroussy.fr
Facility Information:
Facility Name
Gustave Roussy
City
Villejuif
State/Province
Val De Marne
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Gorphe, MD
Phone
0142114211
Ext
+33
Email
philippe.gorphe@gustaveroussy.fr
First Name & Middle Initial & Last Name & Degree
Thibaud Motreff
Phone
0142114211
Ext
+33
Email
thibaud.motreff@gustaveroussy.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study Evaluating Near-infrared Imaging Coupled With Indocyanin Green for Intraoperative Control of Resection Margins in ENT Surgery
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