Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07648160

Contrast-enhanced CBCT With C-arm HyperSight Technology

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Advanced Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

Location status: Recruiting

Location contact

Jelena Lukovic, MD FRCPC MPH MRMD

CONTACT

[email protected]

416-946-4501 ext. 4858

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous contrast-enhanced cone beam computed tomography

Diagnostic Test

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Feasibility of dynamic-contrast-enhanced (DCE) imaging

    Time frame: 18 Months

    Assess tumor visualization and perfusion using the HyperSight C-arm system

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jelena Lukovic, MD FRCPC MPH MRMD

CONTACT

[email protected]

4169464501 ext. 4858

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: IV-CBCT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 15, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.