Contrast-enhanced CBCT With C-arm HyperSight Technology

NCT07648160 | Not Yet Recruiting

• 1 other identifier: 24-5806
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancer

Keywords

IV-contrast-enhanced CT

Outcome Measures

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.

  18 Months

Secondary Outcomes (3)

• Feasibility of dynamic-contrast-enhanced (DCE) imaging

  18 Months

• Image quality of full versus half (17 s) CBCT acquisition, with and without contrast enhancement

  18 Months

• Patient preferences and comfort with the use of IV CBCT during treatment

  18 Months

Study Arms (1)

IV CBCT

EXPERIMENTAL

Diagnostic Test: Intravenous contrast-enhanced cone beam computed tomography

Interventions

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.

IV CBCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to understand/provide consent
• Known renal disease
• Single kidney
• Kidney transplant
• Dialysis
• Contraindication to MRI

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

Location

Central Study Contacts

Jelena Lukovic, MD FRCPC MPH MRMD

CONTACT

4169464501; jelena.lukovic@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 15, 2026

Record last verified: 2026-06

Locations

CA (1)