Study of the ICG Distribution in the Margins of Breast Ca... | NCT02027818

Studies
Study of the ICG Distribution in the Margins of Breast Cancer After Tumorectomy

NCT02027818

Sponsor

Jules Bordet Institute

Status

Completed

Last Update Posted

Dec 15, 2023Actual

Enrollment

20Estimated

Phase

Phase 2

Conditions

Breast 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

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Oct 2014Actual

Completion Date

Oct 2014Actual

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

Dec 11, 2023

Last Update Posted Date

Dec 15, 2023Actual

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

We will observe if ICG fluorescence correlates with margins of breast tumours after iv injection of the contrast agent

Detailed Description

In the operating room:

ICG 0.25 mg/kg will be given as an iv injection at least 20 minutes before the beginning of the operation.

The surgeon will remove the tumour (and the axillary lymph nodes) as usual.

Optionally, peroperative "in vivo" imaging of the dissection of the tumour using the PDE camera will be performed.

In the Laboratory of Pathology:

The "fresh" tumorectomy piece will be processed as usual, and the thick sections for the evaluation of the margins as well as the tissues samples from each margins will be imaged using the PDE in comparison with the fluorescence in the mid part of the tumour and the fluorescent areas will be so delimited (and later analyzed in comparison with standards of known fluorescence intensity).

After fixation, the tumoral tissues will be thereafter processed "as usual".

If fluorescent foci are identified at the level of the axillary piece (in case of CALND), they will be dissected and processed as other lymph nodes. Additionally, metastatic lymph nodes -if present- will also be controlled for their microscopic fluorescence or not.

Using the near-infrared fluorescence microscope, the slides corresponding to the macroscopically fluorescent structures will be analyzed.

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Indocyanine Green	Experimental	study of the correlation between fluorescence and margins of the tumours after iv injection of Indocyanine Green	Drug: Indocyanine Green

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Indocyanine Green	Drug	Observation of the correlation between fluorescence and margins of the tumour after IV injection of ICG	Indocyanine Green

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
- Evaluation of the ability of NIR imaging to show (fluorescent) the tumoral volumes, the tumoral tissues to be analyzed by the pathologist, especially at the level of the operative margins		17 months

Secondary Outcomes

Measure	Description	Time Frame
- Analysis of the correlation between (levels of) ICG fluorescence and tumour margins as defined at the microscopic level by the pathologist		17 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with histopathological diagnosis of mammary cancer who are candidate for tumorectomy, either with SLN selective lymphadenectomy, or with complete axillary node dissection,
Informed consent form signed.

Exclusion Criteria:

Diagnosis of mammary cancer established by "gross" biopsy,
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

Female

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
Danièle Noterman, MD	Jules Bordet Institute	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D000072662	Margins of Excision

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

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