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

NCT02027818 | Completed Phase 2

• 1 other identifier: BR-TUM-ICG-IV
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

margins; tumorectomy

Outcome Measures

Primary Outcomes (1)

• - 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 (1)

• - Analysis of the correlation between (levels of) ICG fluorescence and tumour margins as defined at the microscopic level by the pathologist

  17 months

Study Arms (1)

Indocyanine Green

EXPERIMENTAL

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

Drug: Indocyanine Green

Interventions

Indocyanine Green DRUG

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

Also known as: ICG

Indocyanine Green

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Jules Bordet Institute

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms; Margins of Excision

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Danièle Noterman, MD

  Jules Bordet Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2014
• First Posted: January 6, 2014
• Study Start: January 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 15, 2023

Record last verified: 2013-12

Locations

BE (1)