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

U

University Hospital Heidelberg

Status

Withdrawn

Conditions

Effects of; Movement
Tumor
Radiation; Lesion

Treatments

Behavioral: organ motion

Study type

Interventional

Funder types

Other

Identifiers

NCT02095236
The ESMERALDA Trial

Details and patient eligibility

About

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

Full 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

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

experimental
Experimental group
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
Treatment:
Behavioral: organ motion

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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