The main objective of this study is to evaluate the image quality of a new cone-beam CT imaging system that will be used to acquire images of a wide selection of anatomical locations in patients receiving radiotherapy for cancer.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Qualitative and quantitative comparison of the image quality of the novel
cone-beam CT imaging system to standard cone-beam CT imaging and conventional
fan beam CT imaging used for radiotherapy planning purposes.
Secondary outcome
Evaluation of the suitability of the novel CBCT images for radiation treatment
planning and dose calculation.
Background summary
A novel cone-beam computerized tomography (CT) imaging system has been
developed for image-guided radiotherapy. This new system can acquire cone-beam
CT (CBCT) images faster than previous systems. Furthermore, the new system has
demonstrated increased image quality, resolution and Hounsfield Unit (HU)
accuracy in phantom images compared to previous cone-beam CT systems. This CBCT
system opens new possibilities for use of CBCT images in various radiotherapy
tasks for which previous CBCT images were not optimal. Specifically, the use of
CBCT images for delineation of anatomical structures, radiotherapy treatment
planning and radiation treatment dose calculation is limited with current
on-board imaging technology. The improved image quality of the new system will
be evaluated in a clinical setting with respect to its suitability for tumour
and organ delineation, image-guided radiotherapy and radiation dosimetry.
Study objective
The main objective of this study is to evaluate the image quality of a new
cone-beam CT imaging system that will be used to acquire images of a wide
selection of anatomical locations in patients receiving radiotherapy for
cancer.
Study design
Single arm, non-randomized prospective study.
Study burden and risks
There is no direct benefit expected for the individual patients who participate
in this study. Additional imaging is performed on the novel cone-beam CT
imaging device using x-rays. Additional radiation exposure resulting from the
two additional CBCT images acquired for this study is a small fraction (<0.1%)
of the radiation received during a subject*s standard radiotherapy treatment.
Collected data will not be used for clinical decision making. If the novel CBCT
images provide new information that may lead to improved treatment, the
findings will be communicated to the treating physician but will require
verification using standard imaging procedures.
Hansen Way 3100
Palo Alto CA 34304
US
Hansen Way 3100
Palo Alto CA 34304
US
Listed location countries
Age
Inclusion criteria
The patient will be treated with external beam photon radiotherapy at MAASTRO
for head-and-neck cancer, stage I lung cancer, stage II-IV lung cancer, breast
cancer, or tumours in the abdominal or pelvic region.
Age >= 18 years
Ability to understand the requirements of the study and to give written
informed consent, as determined by the treating physician
Provision of written informed consent
Exclusion criteria
Patient is pregnant
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 |
|---|---|
| ClinicalTrials.gov | NCT05524454 |
| CCMO | NL81936.068.22 |