MedPath

Optical imaging for improved detection and surgery of solid tumors

Completed
Conditions
breast cancer, sentinel lymph node, intraoperative imaging, image-guided surgery
Registration Number
NL-OMON21271
Lead Sponsor
Department of Surgery, University Medical Center Groningen
Brief Summary

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><br> - 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><br> - 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. <br><br>

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
10
Inclusion Criteria

1. Patients with operable invasive breast cancer stage (T1-2N0-1 – stage I and II) proven by histology on a biopsy.

Exclusion Criteria

1. Pregnant women.

2. Significant renal (creatinine >, cardiac, or pulmonary disease (ASA III-IV).

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
- Ergonomics and function of the NIRF imaging system - the NIRF imaging system must not interfere with the standard Sentinel Lymph Node mapping procedure and should be used safely by the surgeon. <br />Duration of data aquisition: 1,5 hour clinical procedure.
Secondary Outcome Measures
NameTimeMethod
Identify sentinel lymph nodes within the allocated procedure (usually 1-1,5 hour)
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