ICG Distribution Using NIF Imaging After IV Injection of ICG in Benign and Malignant Breast Cancer Tissue.

NCT01993576 | Completed Phase 1 DMC

• 1 other identifier: 2013-000100-41
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if NIF fluoresent imaging is an effctive approch to detect the margine of the breast tumoral tissue.

Conditions

Breast Cancer.

Outcome Measures

Primary Outcomes (1)

• Study of the evantual difference of indocyanine in mammalian tissue in patients mastocmemezied for breast canrcinoma.

  Detecting of the fluorescence in between benign and malignant tissue by near infra-red imaging with a camera dictated to identify the margin of the tumor, and Histological detection of indocyanine green distribution in tumor bearing breasts and in axillary pieces of dissection and the detection of tumor cells in lymphe nodes.

  10 months

Secondary Outcomes (1)

• Microscopical detection of indocyanine green in breast tissue.

  10 months.

Study Arms (1)

indocyanine green

EXPERIMENTAL

Indocyanine green is injected intravenously.

Drug: Indocyanine Green

Interventions

Indocyanine Green DRUG

Intravenous injection of 0.25 mg/kg Indocyanine Green (ICG) before the surgery

Also known as: ICG

indocyanine green

Eligibility Criteria

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

You may qualify if:

• Patients with histopathological diagnosis of breast cancer for which a mastectomy with axillary dissection is planned.
• Informed Consent signed.

You may not qualify if:

• Diagnosis of breast cancer established by lumpectomy or "macro-biopsy".
• Operation after neo-adjuvant chemotherapy,
• Age less than 18 years.
• For pre-menopausal women, an operation planned for the second phase of their cycle.
• Inability to give informed consent.
• History of allergy or hypersensitivity to the investigational product, iodine.
• Clinical or biological hyperthyroidism.
• Known "toxic" thyroid nodules or known autonomous (hyperfunctional) thyroid.
• A reported pathological coronary artery disease.
• Creatinine \> 1.5 mg / dl.
• During the 2 weeks before surgery, being on medications which are known to interfere with the ICG (ie anticonvulsants, heparin and haloperidol).
• Pregnancy or breast feeding period.

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Jules Bordet Insitute

Brussels, Belgium, B-1000, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jean-Marie Nogaret, Prof.

  Jules Bordet Institute

  STUDY CHAIR

• Isabelle Veys, MD

  Jules Bordet Institute

  STUDY CHAIR

• Sophie VanKerckhove, biologist

  Jules Bordet Institute

  STUDY CHAIR

• Philippe De Neubourg, MD

  Jules Bordet Institute

  STUDY CHAIR

• Danielle Noterman, MD

  Jules Bordet Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: November 25, 2013
• Study Start: January 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 15, 2014

Record last verified: 2014-07

Locations

BE (1)