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Clinical Trials/NL-OMON21271
NL-OMON21271
Completed
Not Applicable

Evaluation of a Clinical Prototype Near-InfraRed Fluorescence (NIRF) Imaging Device for Sentinel Lymph Node (SLN) Detection in Breast Cancer: a Technical Feasibility Study

Department of Surgery, University Medical Center Groningen0 sites10 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
breast cancer, sentinel lymph node, intraoperative imaging, image-guided surgery
Sponsor
Department of Surgery, University Medical Center Groningen
Enrollment
10
Status
Completed
Last Updated
2 years ago

Overview

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.

- 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.

- 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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Department of Surgery, University Medical Center Groningen

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Not specified

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