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

December 11, 2023 updated by: Jules Bordet Institute

Study of the (Intravenously Injected) Indocyanine Green Distribution in the Margins of Breast Cancer After Tumorectomy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • Jules Bordet Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Indocyanine Green
study of the correlation between fluorescence and margins of the tumours after iv injection of Indocyanine Green
Drug: Indocyanine Green
Observation of the correlation between fluorescence and margins of the tumour after IV injection of ICG
Other Names:
  • ICG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 17 months
17 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jules Bordet Institute

Investigators

  • Principal Investigator: Danièle Noterman, MD, Jules Bordet Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

January 2, 2014

First Submitted That Met QC Criteria

January 2, 2014

First Posted (Estimated)

January 6, 2014

Study Record Updates

Last Update Posted (Actual)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR-TUM-ICG-IV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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