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

NCT ID: NCT02027818

Last Updated: 2023-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-10-31

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.

Conditions

Breast Cancer

Keywords

margins; tumorectomy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Indocyanine Green

study of the correlation between fluorescence and margins of the tumours after iv injection of Indocyanine Green

Group Type: EXPERIMENTAL

Indocyanine Green

Intervention Type: DRUG

Observation of the correlation between fluorescence and margins of the tumour after IV injection of ICG

Interventions

Indocyanine Green

Observation of the correlation between fluorescence and margins of the tumour after IV injection of ICG

Intervention Type: DRUG

Other Intervention Names

ICG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jules Bordet Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danièle Noterman, MD

Role: PRINCIPAL_INVESTIGATOR

Jules Bordet Institute

Locations

Jules Bordet Institute

Brussels, , Belgium

Countries

Belgium

Other Identifiers

BR-TUM-ICG-IV

Identifier Type: -

Identifier Source: org_study_id