No registrations found.
ID
Source
Brief title
Health condition
Gastric cancer; radiotherapy
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility of using fiducial markers in image-guided pre-operative radiotherapy for patients with gastric cancer.
Secondary outcome
- Success rate of marker implantation;
- Safety of marker implantation;
- Stability of markers over time;
- Visibility of markers on planning CT and CBCT;
- Ability to use the markers for image registration of CBCT with planning CT.
Background summary
For pre-operative radiotherapy, the entire stomach with surrounding lymph nodes is included in the clinical target volume. However, the stomach is a highly mobile organ, displaying deformation and motion due to breathing, gastrointestinal filling and peristalsis. Daily cone-beam CT-based patient position verification is used, but visibility of the stomach on cone-beam CT (CBCT) is limited. In our study, we will investigate the feasibility and safety of endoscopic placement of fiducial markers in the stomach. We hypothesize that fiducial markers with high visibility on CT and CBCT benefit CBCT-based position verification and thus improve the accuracy of pre-operative radiotherapy for patients with gastric cancer.
Study objective
Endoscopic placement of fiducial markers in patients with gastric cancer is feasible and beneficial for patient position verification.
Study design
Final analysis will take place after inclusion has been completed.
Intervention
Included patients will undergo endoscopic placement of fiducial markers in the stomach. In addition, extra imaging (CBCT and CT) will be obtained.
Astrid Horst, van der
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
a.vanderhorst@amc.uva.nl
Astrid Horst, van der
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
a.vanderhorst@amc.uva.nl
Inclusion criteria
- Patients with histologically proven primary gastric cancer;
- Referred for pre-operative radiotherapy in the Academic Medical Center;
- Written informed consent.
Exclusion criteria
- Coagulopathy or platelets level < 40.000;
- Endoscopic suspicion of fistula;
- Endoscopic suspicion of active gastric infections;
- High risk for sedation;
- Unwilling to participate in the study and/or sign informed consent;
- Pregnant;
- Age < 18 years.
Design
Recruitment
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 | NL7036 |
| NTR-old | NTR7241 |
| CCMO | NL65080.018.18 |
| OMON | NL-OMON50759 |