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Evaluation of a Clinical Prototype Near-InfraRed Fluorescence (NIRF) Imaging Device for Lymph Node Mapping in Esophageal Cancer: a Technical Feasibility Study.


- candidate number6445
- NTR NumberNTR2003
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-sep-2009
- Secondary IDsBICG08UMCG-NIRF  UMCG
- Public TitleEvaluation of a Clinical Prototype Near-InfraRed Fluorescence (NIRF) Imaging Device for Lymph Node Mapping in Esophageal Cancer: a Technical Feasibility Study.
- Scientific TitleEvaluation of a Clinical Prototype Near-InfraRed Fluorescence (NIRF) Imaging Device for Lymph Node Mapping in Esophageal Cancer: a Technical Feasibility Study.
- ACRONYMN/A
- hypothesisA near-infrared fluorescence camera and a peritumoral injection of indocyanine green may be used for detection of lymph nodes during esophageal resections without affecting the normal operative procedure.
- Healt Condition(s) or Problem(s) studiedEsophageal cancer
- Inclusion criteriaMen and women above the age of 21 who have biopsy-proven esophageal cancer that is deemed operable by the treating surgeon by the current staging protocol at the UMCG (i.e. endoscopy, endo ultrasound, CT thorax/abdomen, PET scan).
- Exclusion criteria1. Significant renal, cardiac, or pulmonary disease (ASA III-IV);
2. History of iodine allergy or anaphylactic reactions to insect bites or medication;
3. Presence or history of hyperthyroidism.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 23-jun-2009
- planned closingdate2-jan-2010
- Target number of participants10
- InterventionsPeritumoral injection with indocyanine green and subsequent imaging using the intraoperative near-infrared fluorescence camera.
- Primary outcomeApplication of the near-infrared fluorescence camera safely without disturbing the normal operative procedure.
- Secondary outcomeDetection of lymph nodes with the near-infrared fluorescence camera.
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. G.M. Dam, van
- CONTACT for SCIENTIFIC QUERIES K.T. Buddingh
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryThe primary aim of the study is to assess whether our Near-Infrared Fluorescence camera may safely be used during esophageal resections. The secondary aim is the intraoperative detection of lymph nodes using indocyanine green and a Near-Infrared Fluorescence camera. Patients undergoing esophagectomy for cancer of the esophagus will receive an intraoperative peritumoral injection with ICG. Imaging will subsequently take place using the NIRF camera to assess whether lymph nodes may be detected.
- Main changes (audit trail)
- RECORD10-sep-2009 - 4-nov-2009


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