Contrast-enhanced CBCT With C-arm HyperSight Technology (IV-CBCT)

June 9, 2026 updated by: University Health Network, Toronto

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 exclusion criteria)
  • Known renal disease
  • Single kidney
  • Kidney transplant
  • Dialysis
  • Contraindication to MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IV CBCT
Diagnostic test: Intravenous 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of IV-contrast enhanced CBCT during image-guided radiotherapy
Time Frame: 18 Months
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.
18 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of dynamic-contrast-enhanced (DCE) imaging
Time Frame: 18 Months
Assess tumor visualization and perfusion using the HyperSight C-arm system
18 Months
Image quality of full versus half (17 s) CBCT acquisition, with and without contrast enhancement
Time Frame: 18 Months
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.
18 Months
Patient preferences and comfort with the use of IV CBCT during treatment
Time Frame: 18 Months
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.
18 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

June 9, 2026

First Submitted That Met QC Criteria

June 9, 2026

First Posted (Actual)

June 15, 2026

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 24-5806

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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