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Evaluation of Intrafractional Motion of Liver Tumors Using Markers (ESMERALDA)

Primary Purpose

Tumor, Effects of; Movement, Radiation; Lesion

Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
organ motion
Sponsored by
University Hospital Heidelberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

experimental

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 4, 2014
Last Updated
May 11, 2018
Sponsor
University Hospital Heidelberg
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1. Study Identification

Unique Protocol Identification Number
NCT02095236
Brief Title
Evaluation of Intrafractional Motion of Liver Tumors Using Markers
Acronym
ESMERALDA
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Administrative barriers
Study Start Date
undefined (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Heidelberg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumor, Effects of; Movement, Radiation; Lesion

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
organ motion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Three-dimensional intra- and interfractional measurement of fiducial marker or transponder motion
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie E Combs, MD
Organizational Affiliation
Department of Radiooncology, University Hospital of Heidelberg, INF 400, 69120 Heidelberg, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Heidelberg
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Intrafractional Motion of Liver Tumors Using Markers

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