Clinical trial NCT05176860: Evaluation of Novel Cone-Beam CT for Guidance and Adaptation of Precision Radiotherapy
Official title: Evaluation of Novel Cone-Beam CT for Guidance and Adaptation of Precision Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Liver Cancer
Breast Cancer
Other Cancer
Lead sponsor: Varian, a Siemens Healthineers Company
Sponsor class: INDUSTRY
First posted: 2022-01-04
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-site study designed to generate data describing the quality and applicability of on-couch high-performance CBCT imaging for anatomy visualization and radiation treatment dosimetry planning.
Primary purpose: OTHER

Brief summary: This is a feasibility study investigating the image quality of a new, high-performance cone beam CT (CBCT) used for on-couch imaging during radiotherapy treatments.

Detailed description: This study focuses on potential benefits of a high performance cone beam CT (CBCT) image guidance system for improved precision in the delivery of radiotherapy. CBCT is currently used during radiation therapy to align the patient to their original treatment plan to increase the precision of radiation delivery. Current CBCT imaging technology requires approximately a minute to acquire an image. In order to acquire images with sufficient quality to allow accurate targeting, the patient may need to perform multiple breath hold maneuvers to "freeze" the motion of tumors that move with the breathing cycle (e.g. lung, liver, and breast tumors). The new high-performance CBCT can acquire an image in approximately 6 seconds, potentially enabling acquisition of images with a single breath hold. Improved motion compensation algorithms used in image reconstruction may allow acquisition of good quality images even while a patient is not holding their breath.

The methodology for the subject's treatment setup, CT simulation, treatment planning, image guidance and treatment delivery will be determined by the subject's treatment team and is not specified by this study. Enrollment in the study may occur after treatment delivery has started but must be prior to the fifth fraction.

Following completion of informed consent to participate in this study, high-performance CBCT imaging will be scheduled immediately before or after one of the subject's first five scheduled radiation treatment fractions. Two research CBCT images will be acquired, one with breath hold, the other with free breathing.

With minimal disruption for participating patients, this study will enable a comparison of (i) the subject's treatment planning fan-beam CT and (ii) the conventional CBCT acquired on an existing treatment unit with (iii) the high-performance CBCT. Image quality of the high performance CBCT image data will thereby be compared to both a best-case standard (fan-beam) and the status-quo for on-couch imaging to isolate and identify improvements.

Eligibility criteria: Inclusion Criteria:

* Subject is scheduled for treatment on one of the five TrueBeam platforms at the NS Health QE2 site.
* Subject is receiving radiation therapy using a breath-hold technique (for example, lung, liver and left breast cancers).

Exclusion Criteria:

* Patient is pregnant or has plans for pregnancy during the period of treatment.
* Patient is unwilling to consent to participating to the study, or for whom informed consent is not possible.

Primary outcomes:
measure: CBCT Image Quality
timeFrame: 1 day
Secondary outcomes:
measure: Dosimetry Calculations
timeFrame: 1 day
measure: Patient Experience
timeFrame: 1 day
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health (QEII)
state: Nova Scotia
Study officials:
References: