No registrations found.
ID
Source
Brief title
Health condition
esophageal cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
To 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)
Background summary
In 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.
Study objective
We 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.
Study design
-
Intervention
MRI scan with nano-contrast agent
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5797 |
| NTR-old | NTR6072 |
| CCMO | NL58570.091.16 |
| OMON | NL-OMON43056 |