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Contrast-enhanced CBCT With C-arm HyperSight Technology

Contrast-enhanced CBCT With C-arm HyperSight Technology: A Feasibility Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07648160
Acronym
IV-CBCT
Enrollment
20
Registered
2026-06-15
Start date
2026-06-24
Completion date
2027-07-01
Last updated
2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancer

Keywords

IV-contrast-enhanced CT

Brief summary

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.

Interventions

DIAGNOSTIC_TESTIntravenous contrast-enhanced cone beam computed tomography

Two 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.

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Primary biopsy-proven cancer * Planning to undergo spatially fractionated radiation therapy * Able to provide informed consent * Willingness to participate in follow-up * ECOG less than or equal to 3 * Normal creatinine (below 109mmol/L), normal eGF

Exclusion criteria

* Unable to understand/provide consent * History of allergic reaction to iodinated IV contrast dye (allergy to MR contrast is not an

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of IV-contrast enhanced CBCT during image-guided radiotherapy18 MonthsFeasibility 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.

Secondary

MeasureTime frameDescription
Feasibility of dynamic-contrast-enhanced (DCE) imaging18 MonthsAssess tumor visualization and perfusion using the HyperSight C-arm system
Image quality of full versus half (17 s) CBCT acquisition, with and without contrast enhancement18 MonthsNoise-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.
Patient preferences and comfort with the use of IV CBCT during treatment18 MonthsAll 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.

Countries

Canada

Contacts

CONTACTJelena Lukovic, MD FRCPC MPH MRMD
jelena.lukovic@uhn.ca4169464501

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026