The primary objective is to study the feasibility of MRI in patients with esophageal tumors. We will study its effectiveness for visualization of the cranial and caudal tumor borders and identification of the involved lymph nodes.
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The feasibility of MRI of esophageal cancer with emphasis on visualization of
1) the tumor extent in longitudinal direction and 2) the involved lymph nodes.
Secondary outcome
Niet van toepassing.
Background summary
Radiotherapy (RT) plays an important role in the treatment of esophageal
cancer. RT is either applied as preoperative treatment for patients in an
operable disease stage or as part of definitive treatment in inoperable cases.
The challenge for RT in esophageal cancer is how to deliver the radiation
accurately to the tumor and involved lymph nodes while minimizing normal tissue
toxicity. The macroscopical disease extent is endoscopically determined by
endoscopic ultrasonography (EUS). Difficulties arise in transfer of these
endoscopic data to the computed tomography (CT) scan used for RT planning.
Delineation of the tumor on CT is tedious due to the poor visibility of the
tumor extension and lack of clear anatomical landmarks in distal direction of
the esophagus. Due to uncertainties in the translation of the endoscopically
identified disease extent to the CT scan used for RT planning, the uncertain
extent of microscopic invasion, setup errors, and respiratory-induced movement
during treatment generous safety margins of several cm are currently used
leading to increased healthy tissue irradiation. If improved pre-treatment
knowledge on the disease extent is available the accuracy of RT for esophageal
cancer can be improved which will allow a reduction of the required safety
margins and decrease the dose to organs at risk. This can most likely be
achieved by improved imaging.
Study objective
The primary objective is to study the feasibility of MRI in patients with
esophageal tumors. We will study its effectiveness for visualization of the
cranial and caudal tumor borders and identification of the involved lymph
nodes.
Study design
The study is a prospective pilot study to test the feasibility of MRI in
patients with esophageal tumors.
Patients who participate in this study will undergo a pre-treatment T2-weighted
(T2w), diffusion weighted imaging (DWI) and dynamic contrast enhanced (DCE) MRI
scan. Further, post-surgery the excision specimen will be imaged. Treatment
protocols are based on routine clinical assessment and will not be altered
based on the findings at MRI.
Study burden and risks
The burden is minimal: patients participating have to visit the hospital once
to undergo MRI before the start of treatment. This visit will be scheduled on a
day when the patient has already an appointment at the hospital. The MRI scan
will take approximately 60 minutes. Further, gadolinium based contrast medium
will be administered; therefore patients suffering from chronic renal
insufficiency will be excluded. No additional side-effects or risks have been
reported on MR imaging, although some patients may experience claustrophobia.
Post-surgery the excision specimen will be imaged which is no burden to the
patient.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
1) Patients with histologically proven primary esophageal cancer for whom a
surgical procedure (either with or without preoperatve CRT) is planned.
2) Referred for treatment in the AMC.
3) Written informed consent.
Further, at least fifteen out of the twenty-five patients referred for
preoperative CRT should undergo pre-treatment EUS-guided radiopaque marker
implantation.
Exclusion criteria
1) Contra indication for MRI.
2) Contra indication for gadolinium contrast administration.
3) Recurrent tumor after an esophageal resection.
4) Pregnant women.
5) Age < 18 years.
6) Unwilling to participate in the study and to sign informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47713.018.14 |