|- candidate number||4230|
|- NTR Number||NTR1492|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-okt-2008|
|- Secondary IDs||BICG01UMCG-NIRF |
|- Public Title||Optical imaging for improved detection and surgery of solid tumors|
|- Scientific Title||Evaluation of a Clinical Prototype Near-InfraRed Fluorescence (NIRF) Imaging Device for Sentinel Lymph Node (SLN) Detection in Breast Cancer: a Technical Feasibility Study|
|- ACRONYM||NIRF imaging|
|- hypothesis||To test if an intraoperative NIRF camera system can detect a NIRF optical contrast agent for SLN in patients with palpable breast cancer.|
|- Healt Condition(s) or Problem(s) studied||Breast cancer, Sentinel lymph node, Image-guided surgery|
|- 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).
3. History of iodine allergy or anaphylactic reactions to insect bites or medication.
4. Presence or history of hyperthyroidism.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-dec-2008|
|- planned closingdate||1-feb-2009|
|- Target number of participants||10|
|- Interventions||Patients with palpable operable invasive 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||- 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. |
Duration of data aquisition: 1,5 hour clinical procedure.
|- Secondary outcome||Identify sentinel lymph nodes within the allocated procedure (usually 1-1,5 hour) |
|- Timepoints||Day of surgery|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- 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 Groningen (UMCG)|
|- Publications||- 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.
|- Brief summary||Rationale:|
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 a better evaluation of tumor staging, prognosis and therapeutic strategy determination. The end-goal of this intraoperative imaging instrument, designed by physicians and physicists, 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. Clinical oncologist surgeons and fundamental physics applied to medical imaging researchers are involved in this project.
To test if an intraoperative NIRF camera system can detect a NIRF optical contrast agent for SLN in patients with palpable breast cancer.
|- Main changes (audit trail)|
|- RECORD||14-okt-2008 - 11-mrt-2009|