Cancer types
  • Digestive tract
Title of study
BioXmark liquid fiducials to enable radiotherapy tumor boosting in rectal cancer, a feasibility trial
Version Number
Approval Date 
7, 22 August 2017
Short Title
Bio-X-Mark
Study site
Principle Investigator
Dr. M. Berbée
Investigator Maastro
Sponsor
Maastro Clinic
Trial registry
Objectives 

To test the feasibility and accuracy of BioXmark fiducial markers for IGRT based rectal tumor boosting

Primary Endpoint 

Positional stability of BioXmark liquid fiducial markers during the treatment course

Secondary Endpoints 

• Visibility/visual stability of BioXmark liquid fiducial markers during the treatment course
• Percentage of markers lost from injection to CT acquisition for RT planning
• Percentage of markers lost during RT
• Safety of BioXmark liquid fiducial marker placement
• Inter-observer variation in gross tumor volume (GTV) localization with and without markers
• Effect of BioXmark liquid fiducial markers on post-treatment MRI images
• Potential BioXmark induced alterations in the surgical specimen Inter-fraction tumor movement
• Intra-fraction tumor movement
• Planning target volume (PTV) margins for rectal tumors, i.e. margins which account for set-up and organ motion
• Simultaneously integrated boost (SIB) technique for tumor boosting in rectal cancer
• Automatic online matching protocol using BioXmark liquid fiducial markers to position the patient before each treatment fraction
• The effect of BioXmark liquid fiducial markers on Radiomics analysis of CT, Cone-beam and MRI images
• The evolution of Radiomics features of the volume between the fiducials on cone beam CT