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WithdrawnNCT02095236ESMERALDAUpdated May 17, 2018

Evaluation of Intrafractional Motion of Liver Tumors Using Markers

An interventional study of organ motion in Tumor, Effects of; Movement and Radiation; Lesion, sponsored by University Hospital Heidelberg. Withdrawn at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-17.

Sponsored by University Hospital Heidelberg · Not applicable, Interventional, and Other

Why this study was withdrawn
Administrative barriers
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Tumor
  • Effects of; Movement
  • Radiation; Lesion

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03

In context

Liver Neoplasms

1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.

Browse Liver Neoplasms studies →

Lead sponsor

University Hospital Heidelberg is the lead sponsor of 175 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    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

    Behavioral: organ motion

Interventions

  • Behavioralorgan 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.

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • University Hospital
    Heidelberg, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02095236
Lead sponsor
University Hospital Heidelberg
Responsible party
Juergen Debus (Prof. Dr. Dr. Jürgen Debus, University Hospital Heidelberg) — Principal investigator
First posted
Mar 24, 2014
Primary completion
May 2018 (estimated)
Last update
May 17, 2018

Study contacts

Stephanie E Combs, MD
principal investigator · Department of Radiooncology, University Hospital of Heidelberg, INF 400, 69120 Heidelberg, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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