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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46787

Enrollment

Registered

2018-06-11

Start date

2018-07-31

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladdercancer urothelial carcinoma of the bladder

Interventions

Injection of at least 3 liquid fiducial markers (BioXmark) in the bladder wall cranial, lateral and caudal (optional) of the macroscopic tumor during cystoscopy.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: * Any contraindication for an cystoscopic procedure * Pregnant women * Age

Design outcomes

Primary

Measure	Time frame
Primary endpoint: * Percentage of BioXmark liquid fiducial markers which are visible and remain in a stable position from the CT acquisition for RT planning to last CBCT Primary safety endpoint: * Number of adverse events potentially associated with application of BioXmark liquid fiducial markers	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)