Clinical trial · Interventional
BioXmark, Rectal Feasibility Trial
BioXmark Liquid Fiducials to Enable Radiotherapy Tumor Boosting in Rectal Cancer, a Feasibility Trial
NCT03265418CI-TRIAL-00040383completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To test the feasibility and accuracy of BioXmark fiducial markers for image guided radiotherapy (IGRT) based rectal tumor boosting in 20 patients referred for long course chemo-radiotherapy of the locally advanced rectal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BioXmark liquid fiducial markers | Device | — | UNRESOLVED |
| Imaging | Other | — | UNRESOLVED |
| surgery or wait-and-see | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BioXmark liquid fiducial markers
- description
- Placement of 4 BioXmark liquid fiducial markers, standard treatment (chemo-radiotherapy followed by surgery or wait-and-see) with extra imaging to evaluate the behaviour of the markers before, during and after the radiotherapy
- interventionNames
- Device: BioXmark liquid fiducial markers
- Other: Imaging
- Procedure: surgery or wait-and-see
Primary outcomes (1)
- measure
- Positional stability of BioXmark liquid fiducial markers during the treatment course
- timeFrame
- will be determined through the course of radiotherapy, an average of 5 weeks
- description
- Positional stability / potential marker migration will be assessed by calculating marker pair distances.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histological or cytological proven adenocarcinoma of the rectum, treated with long course external beam radiotherapy * Age \> 18 years * Have given written informed consent before patient registration Exclusion Criteria: * Patients using anticoagulants: platelet aggregation inhibitors or coumarines * Iodine allergy
References
Publications (0)
Data not yet available
No reference posted for this study.