NIR Fluorescence Imaging During Neck Dissection in Head a... | NCT02027831

Studies
NIR Fluorescence Imaging During Neck Dissection in Head and Neck Cancer Patients After iv Injection of ICG

NCT02027831

Sponsor

Jules Bordet Institute

Status

Unknown status

Last Update Posted

Jul 24, 2014Estimated

Enrollment

10Estimated

Phase

Phase 2

Conditions

Head and Neck Cancer

Interventions

Indocyanine Green

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Oct 2014Estimated

Completion Date

Oct 2014Estimated

First Submitted Date

Jan 2, 2014

First Submission Date that Met QC Criteria

Jan 2, 2014

First Posted Date

Jan 6, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2014

Last Update Posted Date

Jul 24, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine if NIR fluorescent imaging is an effective approach to detect the margins of head and neck tumours or lymph nodes draining the tumour

Detailed Description

Primary objective:

definition of the distribution of intravenously injected ICG in the normal and pathological lymph nodes draining the dissected tumor in head and neck cancer patients or in nodes recurrences in head and neck cancer

Secondary objectives:

Evaluation of the ability of NIR fluorescence imaging to determine the tumoral volume, specifically the margins of the tumoral tissues (in the operating room and in the pathology department)
Analysis of the correlation between ICG fluorescence and tumoral invasion in the dissected lymph nodes

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Indocyanine Green	Experimental	Intravenous injection of 0,25 mg/kg Indocyanine Green	Drug: Indocyanine Green

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Indocyanine Green	Drug		Indocyanine Green	ICG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of the capacity of ICG to detect cervical lymph nodes after IV injection	After IV injection of Indocyanine Green just before the surgery to head and neck cancer patients, we will study the fluorescence due to ICG in cervical lymph nodes and in the primary lesion.	7 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients requiring neck dissection with or without resection of the primary (the decision and the type of neck dissection are preliminary decided during head and neck multidisciplinary oncologic consultation).
Informed consent form signed.

Exclusion Criteria:

Age less than18 years old.
Inability to give informed consent.
History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland.
Documented coronary disease.
Advanced renal impairment (creatinine > 1,5mg/dl).
During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and Heparin).
Pregnancy, breastfeeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Antoine Digonnet, MD	Jules Bordet Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jules Bordet Institute	Recruiting	Brussels	Brussels Capital	1000	Belgium

ID	Term
D006258	Head and Neck Neoplasms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms

Intervention Browse Module

MeSH Terms

ID	Term
D007208	Indocyanine Green

Ancestor Terms

ID	Term
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided