Esophageal Neoplasms Clinical Trial
Official title:
Innovative MRI Techniques to Improve Treatment Stratification of Patients With Esophageal Cancer: an Optimization and Pilot Study
The current standard treatment of resectable esophageal cancer consists of neoadjuvant
chemoradiation followed by resection. However, some patients develop recurrent disease
despite chemoradiation and additional (systemic) treatment might have been indicated. Other
patients show a (nearly) complete response after chemoradiation and could possibly have been
treated with a less extensive treatment regimen. In patients without a threatened
circumferential resection margin (CRM) and lymph node metastases chemoradiotherapy could
possibly be omitted.
Better stratification of patients with esophageal cancer is therefore urgently needed.
Functional magnetic resonance imaging techniques (MRI) can provide in vivo, quantitative
information on tumor biology and may prove to be a useful non-invasive tool for this purpose.
In this project, ultra-small superparamagnetic particles of iron oxide (USPIO) enhanced MRI
using ferumoxytol (Rienso®), diffusion weighted MRI (DWI) and T2* MRI will be developed, both
in terms of improvement of acquisition and data processing techniques.
The outcome of esophageal cancer is poor, with an overall 5-year survival rate of 10%
worldwide. In resectable esophageal cancer, outcome can be improved by multimodality
treatment. The current standard treatment of resectable esophageal cancer consists of
neoadjuvant chemoradiation followed by resection. In the Netherlands, the preferred
chemoradiation regimen consists of carboplatin plus paclitaxel with concurrent radiotherapy
in 23 fractions of 1.8 Gray.1 In a meta-analysis the benefit of chemoradiation over surgery
alone for both adenocarcinoma and squamous cell carcinoma has been shown.2 However, not all
patients benefit from this preoperative treatment regimen. Some patients develop recurrent
disease despite chemoradiation and additional (systemic) treatment might have been indicated.
In contrast, in other patients a (nearly) complete response is observed after chemoradiation
and those patients could possibly have been treated with a less extensive treatment regimen.
Furthermore, in patients without a threatened circumferential resection margin (CRM) and
lymph node metastases chemoradiotherapy could possibly be omitted, reducing patients' risk
for complications and unnecessary, expensive treatment. Thus, stratification of patients with
esophageal cancer is urgently needed. Functional magnetic resonance imaging techniques (MRI)
can provide in vivo, quantitative information on tumor biology and may prove to be a useful
non-invasive tool for this purpose. In this project, ultra-small superparamagnetic particles
of iron oxide (USPIO) enhanced MRI using ferumoxytol (Rienso®), diffusion weighted MRI (DWI)
and T2* MRI will be developed, both in terms of improvement of acquisition and data
processing techniques. For patients with esophageal cancer, the proposed acquisition
techniques and data processing have not been performed before.
Objectives of the study
1. To determine the optimal acquisition technique for USPIO enhanced MRI and DWI and T2*
MRI of esophageal cancer in terms of signal-to-noise ratio, time resolution and spatial
resolution.
2. To determine the optimal data processing approach for USPIO enhanced MRI, DWI and T2*
MRI of esophageal cancer.
3. To explore the correlation between lymph node involvement on USPIO enhanced MRI in
relation to results obtained at pathological examination.
4. To explore the correlation of DWI and T2* MRI of esophageal cancer in relation to
stromal involvement and markers of hypoxia and vasculature obtained at pathological
examination.
5. To explore the accuracy of MRI concerning circumferential tumor delineation compared to
pathological examination.
6. To determine the feasibility to detect lymph node involvement on USPIO enhanced MRI in
initial staging, prior to preoperative chemoradiation therapy.
7. To determine the correlation between lymph node involvement on pre-treatment USPIO MRI
in relation to results obtained at pathology after complete treatment.
The project will be executed in four steps:
1. Optimization of acquisition and data processing techniques of USPIO MRI, DWI and T2* in
five healthy volunteers to optimize field of view, number of slices, slice thickness
(objectives 1 and 2).
2. Assessment of ferumoxytol dose-response with three different dose levels at three
different time points in six healthy volunteers (two per dose-level) (objectives 1 and
2).
3. Using the data of (1) and (2): assessment of USPIO MRI, DWI and T2* MRI in 20 esophageal
cancer patients with clinically suspect lymph nodes directly before surgery (objectives
3, 4 and 5).
4. Using the data of (1) and (2): assessment of USPIO MRI, DWI and T2* MRI in 10 esophageal
cancer patients with clinically suspect lymph nodes, before initial start of the
treatment (objectives 6 and 7).
For step 1 and 2 we aim to include healthy volunteers; for step 3 and 4 we aim to include
patients with esophageal cancer.
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