BioXmark liquid fiducial to enable radiotherapy tumor boosting in rectal cancer, a feasibility trial

BioXmark liquid fiducial to enable radiotherapy tumor boosting in rectal cancer, a feasibility trial - BioXmark, rectal feasibility trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47645

Enrollment

Registered

2018-03-27

Start date

2018-02-02

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

rectal tumor

Interventions

Injection of 4 liquid fiducial markers (BioXmark) in de bowel wall proximal and distal of the tumor during sigmoidoscopy after enema preparation.

boost

liquid markers

radiotherapy

rectal cancer

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: * patients with histological or cytological proven rectal cancer, treated with long course external beam radiotherapy * Age 18 year or older * have given written informed consent

Exclusion criteria

Exclusion criteria: * iodine allergy

Design outcomes

Primary

Measure	Time frame
Positional stability of BioXmark liquid fiducial markers during the treatment course	—

Secondary

Measure	Time frame
Secundary studyparameters/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 Exploratory study parameters/endpoints: * 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 * To develop a simultaneously integrated boost (SIB) technique for tumor boosting in rectal cancer * To determine the potential use of BioXmark liquid fiducial markers for automatic online matching * To verify the effect of BioXmark liquid fiducial markers on Radiomics analysis of CT, Cone-beam and MRI images * To explore the evolution of Radiomics features of the volume between the fiducials on cone beam CT	—

Measure

Time frame

Secundary studyparameters/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 Exploratory study parameters/endpoints: * 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 * To develop a simultaneously integrated boost (SIB) technique for tumor boosting in rectal cancer * To determine the potential use of BioXmark liquid fiducial markers for automatic online matching * To verify the effect of BioXmark liquid fiducial markers on Radiomics analysis of CT, Cone-beam and MRI images * To explore the evolution of Radiomics features of the volume between the fiducials on cone beam CT

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)