To assess the feasibility of nano-MRI in the evaluation of locoregional lymph nodes metastases in patients with esophageal cancer whom underwent nCRT and to study the effect of nCRT on the detection of locoregional lymph nodes metastases with nano-…
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Evaluation of the feasibility and diagnostic accuracy of nano-MRI in detecting
locoregional lymph nodes metastases after nCRT prior to surgery
Secondary outcome
- Identify the quantitative and qualitative effect of controlled mechanical
ventilation motion compared with *breathhold* in detection of lymph node
metastases with nano-MRI after nCRT.
- Diagnostic accuracy of the nano-MRI in detecting metastases in locoregional
lymph nodes in the surgical specimen, ex-vivo after nCRT.
- Diagnostic accuracy of nano-MRI for staging primary esophageal cancer (CT,
PET, EUS).
Background summary
In the Netherlands, more than 2000 patients annually are diagnosed with
esophageal cancer. The curative treatment for resectable cancer consists of
neoadjuvant chemoradiotherapy (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 detecting lymph
node metastases after nCRT is low to moderate for the imaging techniques used
currently in the management of esophageal cancer. A promising new imaging
technique for detecting lymph nodes is nano-MRI. Nano-MRI uses small
iron-dextran particles (USPIO), internalized by macrophages, to visualize
positive nodes. USPIO MRI is already proved in characterizing lymph nodes in
patients with prostate cancer, with a high sensitivity of 65-92% and
specificity of 93-98%.
Study objective
To assess the feasibility of nano-MRI in the evaluation of locoregional lymph
nodes metastases in patients with esophageal cancer whom underwent nCRT and to
study the effect of nCRT on the detection of locoregional lymph nodes
metastases with nano-MRI
Study design
Single center exploratory study.
Study burden and risks
Included patients are already considered for nCRT followed by esophagectomy and
will undergo an additional diagnostic MRI before nCRT and after nCRT prior to
surgery (after induction of anesthesia) with intravenous injections of nano
contrast agent. For this study, depending on other appointments, up to two
extra visits to the Radboud university medical center are required. USPIO
administration may cause (mild) side-effects in a small proportion of patients.
Patients in this explorative study will not benefit from the extra diagnostic
imaging. The results of this study are of high importance for the accurate
re-staging of patients after nCRT. With accurate re-staging of the tumor, a
less invasive surgical procedure without lymph node resection is possible in
patients without viable tumor cells, preventing morbidity. Neoadjuvant therapy,
surgical procedures and follow-up do not differ from regular practice.
Geert Grooteplein 10
Nijmegen 6525GA
NL
Geert Grooteplein 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
* Patients with histologically proven primary esophageal adenocarcinoma or squamous cell carcinoma, who are planned to undergo a esophagectomy after 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
- Epilepsy
- Metal implants that are not compatible with MRI
* Contra-indications for USPIO based contrast agents
- Prior allergic reaction to ferumoxtran-10 or any other iron preparation
- Prior allergic reaction contributed to dextran or other polysaccharide, in any preparation
- Prior allergic reaction to contrast media of any type
- Hereditary hemochromatosis, thalassemia, sickle cell anemia
- Inflammatory diseases of the abdomen
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-003133-18-NL |
| CCMO | NL58570.091.16 |
| OMON | NL-OMON28048 |