|- candidate number||5429|
|- NTR Number||NTR1700|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-mrt-2009|
|- Secondary IDs||BICG26UMCG-NIRF ICG enhanced SLNB|
|- Public Title||Evaluatie van een nieuwe optische beeldvormingstechniek voor de detectie van de schildwachtklier bij patienten met borstkanker.|
|- Scientific Title||Evaluation of Indocyanine Green (ICG) enhanced Near-InfraRed Fluorescence (NIRF) Imaging for Intra-Operative Sentinel Lymph Node (SLN) detection in Breast-conserving Surgery.|
|- ACRONYM||NIRF SLNB|
|- hypothesis||This non-inferiority study specifies as a null hypothesis that ICG enhanced NIRF imaging is inferior in detecting sentinel lymph nodes compared to the current standard treatment (technetium-99m combined with Patent Blue).|
|- Healt Condition(s) or Problem(s) studied||Breast cancer|
|- Inclusion criteria||Patient with operable stage I-II breast cancer diagnosed preoperatively by core biopsy or cytology (cT1-2N0). |
|- Exclusion criteria||1. 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. 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 received||no|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-mei-2009|
|- planned closingdate||1-mei-2011|
|- Target number of participants||200|
|- Interventions||Patients with operable breast cancer stage I-II undergoing a lumpectomy, combined with a sentinel lymph node procedure, will receive prior to a lumpectomy and SLN procedure an intratumoral injection with indocyanin green (ICG).
During the operative procedure NIRF imaging for detection of the SLN (i.e. ICG accumulation) will take place.
|- Primary outcome||Whether ICG enhanced NIRF imaging is able to detect sentinel lymph nodes as good as or better than the standard technique (technetium-99 labelled colloid and Patent Blue) during breast surgery in 97%± 2% of the cases. |
|- Secondary outcome||The number of lymph nodes detected by ICG enhanced NIRF imaging during breast surgery. |
|- Timepoints||Day of surgery.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. G.M. Dam, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. G.M. Dam, van|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), Department of Surgery|
(Source(s) of Monetary or Material Support)
|University Medical Center Utrecht (UMCU), Department of Surgery |
|- Publications||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. |
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 summary||Rationale:|
This project consists on the clinical validation of an imaging modality 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 ability to detect the sentinel lymph node (SLN) in patients with breast cancer compared to the standard procedure in a non-inferiority study design. The sentinel lymph node technique, based on the propagation of cancer cells in the lymphatic system, allows a better evaluation of tumor staging, prognosis and therapeutic strategy determination. The end-goal is to significantly improve the detection and efficiency of the technique in order to reduce the false negative rate and then the recurrence risk, as well as the operative morbidity in future studies on near-infrared tumor-targeted optical contrast agents.
|- Main changes (audit trail)|
|- RECORD||9-mrt-2009 - 14-sep-2009|