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


- candidate number6673
- NTR NumberNTR2083
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-okt-2009
- Secondary IDsBICG01 UMCG-NIRF
- Public TitleEvaluatie van een prototype nabij-infrarood fluorescentie (NIRF) camera systeem voor de detectie van de schildwachtklier bij patiŽnten met borstkanker: Technische haalbaarheidsstudie.
- Scientific TitleEvaluation of a Clinical Prototype Near-InfraRed Fluorescence (NIRF) Imaging Device for Sentinel Lymph Node (SLN) Detection in Breast Cancer Patients: a Technical Feasibility Study.
- ACRONYMNIRF SLNB
- hypothesisThis technical feasibility study hypothesizes that an ICG enhanced near-infrared fluorescence (NIRF) imaging camera enables the detection of the sentinel lymph node (SLN) in breast cancer patients.
- Healt Condition(s) or Problem(s) studiedBreast cancer
- Inclusion criteriaWomen 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 criteria1. Refusal of the patient to be included in the study;
2. Pregnant or breast-feeding;
3. Significant renal dysfunction (serum creatinine above 400 micromol/L);
4. Significant cardiac and/or pulmonary disease (ASA III-IV);
5. History of iodine allergy or anaphylactic reactions to insect bites or medication;
6. Presence or history of hyperthyroidism;
7. Recent surgery on the armpit.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mei-2009
- planned closingdate1-jan-2010
- Target number of participants10
- InterventionsPatients with stage I-II biopsy proven breast cancer who undergo a standard lumpectomy combined with a sentinel lymph node (SLN) procedure, will receive an peritumoural injection with indocyanine green (ICG). Simultaneously with the localization of the SLN by the standard detection procedure (i.e. radioactive colloid detection by a hand-held gamma probe and visual observation of the presence of Patent blue), a NIRF camera system will capture images of the operative field for the detection of the NIRF signal derived from ICG present in the lymphatic vessels and lymph nodes.
- Primary outcomeThe 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 outcomeThe 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.
- TimepointsDay of surgery.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. G.M. Dam, van
- CONTACT for SCIENTIFIC QUERIESDr. G.M. Dam, van
- Sponsor/Initiator University Medical Center Groningen (UMCG), Department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications1. 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.
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.
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.
- Brief summaryRationale: This project consists on the realization followed by the clinical validation of a medical instrument dedicated to sentinel lymph nodes identification and localization in the case of breast cancer. An intra-operative near-infrared fluorescence imaging camera will be evaluated for its technical feasibility to detect the sentinel lymph node (SLN) in patients with breast cancer. The sentinel lymph node technique, based on the propagation of cancer cells in the lymphatic system, allows for a better evaluation of tumor staging, prognosis and therapeutic strategy determination. The end-goal of this intra-operative imaging instrument, designed by physicians and physicists, is to improve the detection and efficiency of the technique significantly in order to reduce the false negative rate and then the recurrence risk, as well as the operative morbidity. Clinical oncologist surgeons and fundamental physics applied to medical imaging researchers are involved in this project.
- Main changes (audit trail)
- RECORD28-okt-2009 - 5-nov-2009


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