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Clinical Trials/EUCTR2012-005788-28-AT
EUCTR2012-005788-28-AT
Active, not recruiting
Not Applicable

Influence of Body Mass Index on the identification rate of indocyanine green (ICG) fluorescence mapping for sentinel lymph node detection in early breast cancer - ICG Study

andeskrankenhaus Fedkirch0 sitesDecember 30, 2013
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DrugsPulsion

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
andeskrankenhaus Fedkirch
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 30, 2013
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
andeskrankenhaus Fedkirch

Eligibility Criteria

Inclusion Criteria

  • •\-biopsy proven invasive breast cancer in women of any age over 18 years of age
  • •\-tumours measuring \< 5cm in maximum diameter radiologically (mammography, ultrasound or MRI)
  • •\-no evidence of pathological axillary lymph nodes clinically or on ultrasound scan.
  • •\-SLNB recommended as part of their surgical management for breast cancer
  • •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 50
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 10

Exclusion Criteria

  • •women unable to provide informed consent
  • •\- history of previous breast cancer
  • •\- prior axillary surgery or breast excision biopsy
  • •\- prior axillary surgery or a diagnostic excision biopsy of the breast
  • •\- pregnant or lactating women
  • •\- hypersensitivity to indocyanine green (ICG) or to sodium iodide
  • •\- hypersensitivity to iodine
  • •\- patients with hyperthyroidism or toxic thyroid adenomas

Outcomes

Primary Outcomes

Not specified

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