Organ Motion and Early Tumor Response Measurement
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|ClinicalTrials.gov Identifier: NCT02139488|
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : June 27, 2019
|Condition or disease||Intervention/treatment|
|Esophageal Cancer Chemoradiation||Other: Fiducial markers Other: Fiducial markers, Pet and MRI|
A single center prospective observational study will be performed in esophageal cancer patients. This study registers motion of the esophageal tumor, using 4D planning CT scans and repeated 4D CBCT scanning. Motion of fiducial markers inserted into the esophageal wall, will be used as a surrogate for tumor motion in the limited image quality of CBCT scans.
Patients planned for trimodality treatment will additionally be imaged by serial 4D Pet CT and MRI in week 0 (before start chemoradiotherapy), week 3 (during chemoradiotherapy) and week 10 (just prior to surgery) to observe (early) signs of tumor response.
Patients planned for definitive chemoradiation will not receive extra MRI imaging during treatment because of the inability to correlate this imaging with pathological response.
|Study Type :||Observational|
|Actual Enrollment :||80 participants|
|Official Title:||Organ Motion and Early Tumor Response Measurement During Chemotherapy for Esophageal Cancer|
|Actual Study Start Date :||April 18, 2014|
|Actual Primary Completion Date :||December 2018|
|Actual Study Completion Date :||December 2018|
neoadjuvant or definitive chemoradiation
Esophageal cancer patients planned for neoadjuvant or definitive chemoradiation.
Other: Fiducial markers
Other: Fiducial markers, Pet and MRI
Insertion of Fiducial markers in esophageal wall.
- To quantify motion of the esophageal tumor over the course of chemoradiation [ Time Frame: 6 weeks ]
The outcome measures will be assessed by tracking the motion of the fiducial markers at the daily 4D CBCT (four dimensional cone beam CT scan). (primary outcome)
By observing the motion of the fiducial, the exact setup error, breathing motion amplitudes, intra- and inter-fraction motion can be assessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139488
|The Netherlands cancer Institute|
|Amsterdam, Noord Holland, Netherlands, 1066CX|
|Principal Investigator:||Francine Voncken, MD||NKI-AvL|