A feasibility study of indocyanine green (ICG) fluorescence mapping for sentinel lymph node detection in early breast cancer - ICG10

Phase 1

• Conditions: Primary breast cancer

• Registration Number: EUCTR2009-016743-18-GB
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-28
• Study Completion: 2012-03-14
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

- biopsy proven invasive breast cancer in women over 18.
- 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.
- able to give written informed consent

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified