Feasibility of endoscopic placement of fiducial markers and marker-based image-guided pre-operative radiotherapy in patients with gastric cancer

Completed

• Conditions: Gastric cancer; gastric carcinoma; stomach cancer; 10017990

• Registration Number: NL-OMON50759
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-03-04
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 14

Inclusion Criteria

- Patients with histologically proven primary gastric cancer;
- Referred for pre-operative radiotherapy in the AMC;
- 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Feasibility of using fiducial markers in image-guided pre-operative<br /><br>radiotherapy for patients with gastric cancer.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Success rate of marker implantation;<br /><br>- Safety of marker implantation;<br /><br>- Stability of markers over time;<br /><br>- Visibility of markers on planning CT and CBCT;<br /><br>- Ability to use the markers for image registration of CBCT with planning CT;<br /><br>- Potential benefit of fiducial marker-based image-guided radiotherapy.</p><br>