Evaluation of Intrafractional Motion of Liver Tumors Using Markers
- Conditions
- Effects of; MovementRadiation; LesionTumor
- Interventions
- Behavioral: organ motion
- Registration Number
- NCT02095236
- Lead Sponsor
- University Hospital Heidelberg
- Brief Summary
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
- Detailed Description
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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description experimental organ motion 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
- Primary Outcome Measures
Name Time Method Three-dimensional intra- and interfractional measurement of fiducial marker or transponder motion One treatment session for one dataset 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital
🇩🇪Heidelberg, Germany