Tumor Clinical Trial
— ESMERALDAOfficial 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
NCT number | NCT02095236 |
Other study ID # | The ESMERALDA Trial |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated |
Verified date | May 2018 |
Source | University Hospital Heidelberg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | May 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital | Heidelberg |
Lead Sponsor | Collaborator |
---|---|
University Hospital Heidelberg |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | One treatment session for one dataset |
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