Evaluation of Intrafractional Motion of Liver Tumors Using Markers

NCT ID: NCT02095236

Last Updated: 2018-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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

Conditions

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Tumor Effects of; Movement Radiation; Lesion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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experimental

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

Group Type EXPERIMENTAL

organ motion

Intervention Type BEHAVIORAL

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.

Interventions

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organ motion

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Heidelberg

OTHER

Sponsor Role lead

Responsible Party

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Juergen Debus

Prof. Dr. Dr. Jürgen Debus

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephanie E Combs, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Radiooncology, University Hospital of Heidelberg, INF 400, 69120 Heidelberg, Germany

Locations

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University Hospital

Heidelberg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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The ESMERALDA Trial

Identifier Type: -

Identifier Source: org_study_id

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