Evaluation of Intrafractional Motion of Liver Tumors Using Markers

N/AWithdrawnNCT02095236

University Hospital Heidelberg

Overview

Radioopaque fiducial markers or electro-magnetic transponders will be implanted into or in close proximity of the tumor. During a radiotherapy treatment session image and/or signal acquisition will be performed by ultrasound, computed tomography, magnetic resonance imaging or by specialized signal detectors The data will help to characterize tumor and organ motion during one treatment session which may in fact have impact on dose distribution

With the development of more conformal and precise radiation techniques such as Intensity-Modulated Radiotherapy (IMRT), Stereotactic Body Radiotherapy (SBRT) and Image-Guided Radiotherapy (IGRT), patients with hepatic tumors could be treated with high local doses by sparing normal liver tissue. However, frequently occurring large HCC tumors are still representing a dosimetric challenge in spite of modern high sophisticated RT modalities. This interventional clinical study has been set up to evaluate the value of different fiducial markers, and to use the modern imaging methods for further treatment optimization using physical and informatics approaches.Radioopaque fiducial markers or electro-magnetic transponders will be implanted into or in close proximity of the tumor. During a radiotherapy treatment session image and/or signal acquisition will be performed by ultrasound, computed tomography, magnetic resonance imaging or by specialized signal detectors The data will help to characterize tumor and organ motion during one treatment session which may in fact have impact on dose distribution

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Conditions

Tumor Effects of; Movement Radiation; Lesion

Interventions

organ motionBEHAVIORAL

Three-dimensional intrafractional motion of a fiducial marker or a transponder during a radiotherapy treatment session. Image and/or signal acquisition will be performed by ultrasound, computed tomography, magnetic resonance imaging or by specialized signal detectors.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * indication for high precision radiotherapy of primary and secondary liver tumors using IGRT (image-guided radiotherapy) * age ≥ 18 years of age * ability of subject to understand character and individual consequences of the clinical trial * written informed consent (must be available before enrolment in the trial) Exclusion Criteria: * refusal of the patients to take part in the study * medical reasons impeding marker implantation or IGRT for treatment of liver tumors. * non-compliance of patients

Locations (1)

University Hospital

Heidelberg, Germany

Outcomes

Primary Outcomes

Three-dimensional intra- and interfractional measurement of fiducial marker or transponder motion

Three-dimensional intrafractional motion of a fiducial marker or a transponder will be recorded and analyzed during radiotherapy. Image and/or signal acquisition will be performed by ultrasound, computed tomography, magnetic resonance imaging or by specialized signal detectors. The data will help to characterize tumor and organ motion during one treatment session which may in fact have impact on dose distribution. Prediction of tumor motion is the prerequisite for innovative adaptive radiotherapy techniques.

Time frame: One treatment session for one dataset

Data from ClinicalTrials.gov

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