Contrast-enhanced CBCT With C-arm HyperSight Technology
ConditionAdvanced Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this trial
This is a single-arm prospective, feasibility study evaluating the intravenous contrast-enhanced cone beam computed tomography (IV CBCT) for image guidance during radiotherapy. Patients treated with SFRT will receive IV-contrast enhanced CT and fMRI before treatment for simulation purposes. Additionally, patients will receive mpMRI just before and IV-contrast enhanced CBCT during their second and last fraction of RT, in addition to the standard of care CBCT that is acquired for daily image-guided patient positioning. Patients will undergo both IV-contrast enhanced CBCT and treatment on the TrueBeam with HyperSight imaging capability. We hypothesize IV contrast enhanced CBCT is feasible, well-tolerated by patients and improves the visibility of the target.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Primary biopsy-proven cancer
Planning to undergo spatially fractionated radiation therapy
Able to provide informed consent
Willingness to participate in follow-up
Disqualifiers
Unable to understand/provide consent
History of allergic reaction to iodinated IV contrast dye (allergy to MR contrast is not an exclusion criteria)
Known renal disease
Single kidney
Trial design
Design model
Single group
Treatments tested in this trial
Intravenous contrast-enhanced cone beam computed tomography
Diagnostic testTwo half-arc IV-contrast enhanced CBCT scans and mpMRI seuqences in addition to their routine standard of care CBCT that is done as part of image-guided radiotherapy. These scans will be done during the second and last fraction of treatment.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: IV CBCTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of IV-contrast enhanced CBCT during image-guided radiotherapy
Feasibility of IV-contrast enhanced CBCT in visualizing tumors, vascular structures and tumour micro-environment changes during image-guided radiotherapy. The contrast-to-noise ratio, measuring the ability of an imaging modality to differentiate between various contrasts against the background noise, will be calculated and compared between CT and CBCT, and between with and without contrast acquisition.
Time frame
18 MonthsSecondary outcomes
1
Feasibility of dynamic-contrast-enhanced (DCE) imaging
Assess tumor visualization and perfusion using the HyperSight C-arm system
Time frame
18 Months2
Image quality of full versus half (17 s) CBCT acquisition, with and without contrast enhancement
Noise-to-contrast evaluation of full and half CBCT acquisitions to ultimately assess sufficiency of scans for patient positioning and tumor visualization, and reduction of on-couch imaging time.
Time frame
18 Months3
Patient preferences and comfort with the use of IV CBCT during treatment
All patients will be asked to complete a patient experience survey to gauge their perceptions of receiving additional IV contrast during their CBCT. All questions are answered on a 5-part Likert scale (strongly agree to strongly disagree) and grouped according to construct (knowledge, feelings and benefits). Data will be analyzed using descriptive statistics. Correlations will be examined between patient demographics (age, gender, ECOG performance status, ) and survey responses to identify any trends or specific needs.
Time frame
18 MonthsSponsors and contacts
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Source ClinicalTrials.gov