Evaluation of Intrafractional Motion of Liver Tumors Using Markers

NCT02095236 | Withdrawn

• 1 other identifier: The ESMERALDA Trial
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Tumor; Effects of; Movement; Radiation; Lesion

Outcome Measures

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.

  One treatment session for one dataset

Study Arms (1)

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

organ motion BEHAVIORAL

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.

experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

University Hospital

Heidelberg, Germany

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Organ Motion

Intervention Hierarchy (Ancestors)

Movement; Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Stephanie E Combs, MD

  Department of Radiooncology, University Hospital of Heidelberg, INF 400, 69120 Heidelberg, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Dr. Jürgen Debus

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 24, 2014
• Primary Completion: May 1, 2018
• Last Updated: May 17, 2018

Record last verified: 2018-05

Locations

DE (1)