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OPtical Imaging for lymph node metastatic guidance in Minimally InvaSive esophagecTomy


- candidate number26790
- NTR NumberNTR6343
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-mrt-2017
- Secondary IDsNL61189.091.17  Radboud UMC
- Public TitleOPtical Imaging for lymph node metastatic guidance in Minimally InvaSive esophagecTomy
- Scientific TitleOPtical Imaging for lymph node metastatic guidance in Minimally InvaSive esophagecTomy
- ACRONYMOPTIMIST study
- hypothesisWe hypothesize that it is possible to detect lymph nodes metastases after neoadjuvant chemoradiotherapy (nCRT) during sugery with fluorescence imaging by patients with esophageal cancer. Better diagnosis may preclude unnecessary lymph node dissections, which still is the current standard. Patients who do not need a lymph node dissection due to the better diagnostic accuracy will probably have less morbidity and a better quality of life.
- Healt Condition(s) or Problem(s) studiedEsophageal cancer, Oesophagectomy
- Inclusion criteria• Patients with biopsy proven esophageal cancer, who are planned to undergo an esophagectomy
• Patients with suspected lymph nodes metastases on EUS, CT or PET
• Age > 18 years
• Providing informed consent
- Exclusion criteria• Unable to provide informed consent
• Known pregnancy or breastfeeding
• Contra-indications for fluorescence tracer
• Concomitant malignancies
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jun-2017
- planned closingdate1-apr-2018
- Target number of participants20
- InterventionsTargeted fluorescence imaging
- Primary outcomeTo assess the feasibility and safety of intra-operative fluorescence imaging in patients with esophageal cancer who will undergo esophagectomy.
- Secondary outcome• To assess whether lymph node metastases can be visualized by fluorescence imaging
• To assess the fluorescence signal in malignant and non-malignant tissue
• To assess the correlation between localization of the fluorescently-labeled antibody and expression of the biomarker in tumor and healthy tissue.
• To assess the effect of nCRT on the fluorescence signal
• Define which dose is the optimal dose for further development
- Timepoints-
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Didi de Gouw
- CONTACT for SCIENTIFIC QUERIES Didi de Gouw
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Centre Nijmegen
- Publications
- Brief summaryIn operable patients suffering from esophageal adenocarcinoma (EAC), surgical resection of the tumor in combination with a two-field lymph node (LN) resection after neoadjuvant chemoradiotherapy is considered the cornerstone of intentionally curative treatment. However, only 30% of patients are diagnosed post-operatively with LN metastases, which implies that in 70% of patients no LN metastases are present. In these cases restricted surgery, local endoscopic procedures (ie. EMR/ESD) or even a ‘wait and see’ policy could be less harmful alternatives. We hypothesize that accurate (submillimeter) detection of metastatic disease in lymph nodes during surgery may preclude unnecessary standard lymph node dissections and will result in less morbidity, a better quality of life, and lower costs. The final aim of this work is to create a paradigm shift in surgical oncology practice by personalizing the treatment strategy in cancer with accurate intraoperative knowledge of LN status.
- Main changes (audit trail)
- RECORD1-mrt-2017 - 1-jun-2017


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