To determine inter- and intra-fraction fiducial and patient position reproducibility in order to determine appropriate safety margins for liver SBRT treatment on Ethos.
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary parameters are inter- and intra-fraction fiducial position
reproducibility on the Ethos.
Secondary outcome
not applicable.
Background summary
One of the possible treatments for patients with liver tumours (hepatocellular
carcinoma (HCC) or liver metastases) at the Erasmus MC is stereotactic body
radiation therapy (SBRT) on the Cyberknife. To spare the organs at risk,
suboptimal coverage of the planning target volume is sometimes accepted on the
Cyberknife. The Ethos treatment system is equipped with a novel cone-beam CT
(CBCT), which provides higher quality images. This makes it possible to
consider online adaptive radiotherapy with daily plan adaptation, potentially
leading to a higher dose on the tumour whilst sparing the surrounding healthy
tissue more.
Study objective
To determine inter- and intra-fraction fiducial and patient position
reproducibility in order to determine appropriate safety margins for liver SBRT
treatment on Ethos.
Study design
A prospective, single arm cohort study.
Study burden and risks
Nine Hypersight CBCTs will be made of each patient. These will be made over
three sessions, with three CBCTs per session (41 mSv or 0.041Gy in total,
compared to 48-60Gy of total treatment). The patients will be asked to make
these scans in end-exhalation breath-hold, with each breath-hold lasting six
seconds. The imaging sessions will last fifteen minutes, and will take place
immediately before or after the standard treatment fraction on the Cyberknife.
There will be no direct personal benefit for the participants.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
• Written informed consent;
• Patients discussed in multidisciplinary tumor board;
• Patients diagnosed with liver metastases and referred to the dept. of
Radiotherapy to undergo treatment with stereotactic radiotherapy; or patient
>=65 years, diagnosed with HCC and referred to the dept. of Radiotherapy to
undergo standard treatment;
• Able to comply with breath-hold requirements.
Exclusion criteria
• Eligible for surgery, ablation or liver transplantation.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86070.078.24 |