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Clinical Trials/EUCTR2013-005178-23-BE
EUCTR2013-005178-23-BE
Active, not recruiting
Not Applicable

Study of the (intravenously injected) Indocyanine Green distribution in the margins of breast cancer after tumorectomy

Jules Bordet Institute0 sitesDecember 19, 2013
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DrugsIndocyanine Green Pulsion 25 mg

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Jules Bordet Institute
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 19, 2013
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

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.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 20
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

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

Outcomes

Primary Outcomes

Not specified

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