Clinical trial NCT02095236: Evaluation of Intrafractional Motion of Liver Tumors Using Markers
Official title: Evaluation of Inter- and Intrafractional Motion of Liver Tumors Using Interstitial Markers and Implantable Electro-magnetic Radiotransmitters in the Context of Image-guided Radiotherapy (IGRT) - the ESMERALDA Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tumor
Effects of; Movement
Radiation; Lesion
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2014-03-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: Three-dimensional intra- and interfractional measurement of fiducial marker or transponder motion
timeFrame: One treatment session for one dataset
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital
Study officials:
affiliation: Department of Radiooncology, University Hospital of Heidelberg, INF 400, 69120 Heidelberg, Germany
name: Stephanie E Combs, MD
role: PRINCIPAL_INVESTIGATOR
References: