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Preoperative staging by combidex MRI in patients with resectable esophageal carcinoma


- candidate number24744
- NTR NumberNTR6072
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-aug-2016
- Secondary IDsNL58570.091.16 
- Public TitlePreoperative staging by combidex MRI in patients with resectable esophageal carcinoma
- Scientific TitlePreoperative staging by combidex MRI in patients with resectable esophageal carcinoma
- ACRONYMPRECIES study
- hypothesisWe hypothesize that it is possible to detect lymph nodes metastases after neoadjuvant chemoradiotherapy (nCRT) prior to surgery with nano-MRI in 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
- Inclusion criteria• Patients with recently biopsy proven esophageal cancer, who are planned to undergo a esophagectomy with nCRT
• Patients with suspected lymph nodes metastases on EUS or CT before nCRT
• Age > 18 years
• Providing informed consent
- Exclusion criteria• Unable to provide informed consent
• Known pregnancy or breastfeeding
• Contra-indications for MRI
• Contra-indications for USPIO based contrast agents
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 1-okt-2016
- planned closingdate1-okt-2017
- Target number of participants20
- InterventionsMRI scan with nano-contrast agent
- Primary outcomeTo assess the feasibility and diagnostic accuracy of nano-MRI in detecting locoregional lymph node metastases in patients with esophageal cancer whom underwent nCRT
- Secondary outcome- Diagnostic accuracy of the nano-MRI under anesthesia and controlled mechanical ventilation motion in detecting locoregional lymph node metastases in patients with esophageal cancer whom underwent nCRT
- Diagnostic accuracy of the nano-MRI in detecting locoregional lymph node metastases ex-vivo after nCRT
- Identify the effect of nCRT on the detection of lymph nodes metastases with nano-MRI
- Identify the quantitative effect of anesthesia and controlled mechanical ventilation motion MRI compared with ‘breathhold’ MRI.
- Compare the diagnostic accuracy of nano-MRI in detecting lymph node metastases with clinical staging results of esophageal cancer (CT, PET, EUS)
- 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 the Netherlands, more than 2000 patients are diagnosed with esophageal cancer. The curative treatment for resectable cancer consists of nCRT followed by surgical resection of the tumor as well as regional lymph nodes and is associated with severe mortality and morbidity and a substantial impact on quality of life. After nCRT, the percentage of patients with metastatic lymph nodes appears to reduce from 75% to 31% due to a pathological complete response. Accurate lymph node staging before surgery may reduce the number of unnecessary lymph node dissections and prevent morbidity. However, the sensitivity and specificity for determining lymph node metastasis is low to moderate for the imaging techniques used currently in the management of esophageal cancer. A promising new imaging technique for detecting lymph node metastases is nano-MRI. Nano-MRI uses small iron-dextran particles (USPIO), internalized by macrophages, to visualize positive nodes. nano-MRI is already proved in characterizing lymph nodes in patients with prostate cancer, with a high sensitivity and specificity of 65-92% and 93-98%. This imaging technique may bridge some of the limitations of existing imaging for nodal characterization in esophageal cancer and thereby may reduce the number of unnecessary lymph node dissections.
- Main changes (audit trail)
- RECORD5-aug-2016 - 10-nov-2016


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