Evaluatie van een prototype nabij-infrarood fluorescentie (NIRF) camera systeem voor de detectie van de schildwachtklier bij patiënten met borstkanker: Technische haalbaarheidsstudie.

Recruiting

Conditions: Breast cancer.

Registration Number: NL-OMON28200

Lead Sponsor: niversity Medical Center Groningen (UMCG), Department of Surgery.

Brief Summary: 1. Intraoperative identification of sentinel lymph nodes by near-infrared fluorescence imaging in patients with breast cancer. Tagaya N, Yamazaki R, Nakagawa A, Abe A, Kiyoshige H, Kubota K, Oyama T. Am J Surg 2008;195:850-853. <br> 2. Evaluation of breast lymphatic pathways with indocyanine green fluorescence imaging in patients with breast cancer. Ogasawara Y, Ikeda H, Takahashi M, Karasaki K, Doihara H. World J Surg 2008;32:1924-1929. <br> 3. Imaging of lymph flow in breast cancer patients after microdose administration of a near-infrared fluophore: Feasibility study. Sevick-Muraca EM, Sharma R, Rasmussen JC, Marshall MV, Wendt JA, Pham HQ, Bonefas E, Houston JP, Sampath L, Adams KE, Blachard DK, Fischer RE, Chiang SB, Elledge R, Mawad ME. Radiology 2008; 246: 734-741.

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

Women above the age of 21 with biopsy-proven breast cancer, and who are planning to undergo sentinel lymph node mapping for staging and treatment of their disease.

Exclusion Criteria

1. Refusal of the patient to be included in the study;

2. Pregnant or breast-feeding;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main endpoints of this feasibility study are ergonomics and function of the imaging system. The NIRF imaging system should not interfere with the standard SLN mapping procedure and used safely by the surgeon while detection of ICG takes place. Safely is defined as: no increased risk of infection, no interference with the standard procedure and no excessive prolongation of the operative procedure (i.e. more than 2,5 hours).

Secondary Outcome Measures

Name	Time	Method
The secondary endpoint of this feasibility study is the number and location of detected sentinel lymph nodes compared to the standard detection of SLNs with the use of patent blue and technetium-99 labeled colloid.