BioXmark liquid fiducial markers for image guided radiotherapy in bladder cancer, a safety and performance trial

Phase 3

Completed

• Conditions: Bladdercancer; urothelial carcinoma of the bladder; 10038364; 10004994

• Registration Number: NL-OMON46787
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

* Patients with histologically proven primary bladder cancer
* Referred for bladder conserving (chemo-)radiotherapy in the AMC

Exclusion Criteria

* Any contraindication for an cystoscopic procedure
* Pregnant women
* Age < 18 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br><br /><br>* Percentage of BioXmark liquid fiducial markers which are visible and remain<br /><br>in a stable position from the CT acquisition for RT planning to last CBCT<br /><br><br /><br>Primary safety endpoint:<br /><br>* Number of adverse events potentially associated with application of BioXmark<br /><br>liquid fiducial markers </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>* Percentage of markers lost from injection to the CT acquisition for RT<br /><br>planning<br /><br>* Percentage of patients in which markers can be used for target delineation<br /><br>* Percentage of patients in which markers can be used for patient set-up<br /><br><br /><br><br /><br>Explorative endpoints:<br /><br>* Time needed and easiness of application procedure of BioXmark liquid fiducial<br /><br>marker<br /><br>* Possibility of using BioXmark liquid fiducial markers for automatic online<br /><br>matching</p><br>