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Evaluation of Intrafractional Motion of Liver Tumors Using Markers

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02095236
Acronym
ESMERALDA
Enrollment
0
Registered
2014-03-24
Start date
Unknown
Completion date
Unknown
Last updated
2018-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effects of; Movement, Radiation; Lesion, Tumor

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

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.

Sponsors

University Hospital Heidelberg
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Three-dimensional intra- and interfractional measurement of fiducial marker or transponder motionOne treatment session for one datasetThree-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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026