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Recruiting NCT07648160

Contrast-enhanced CBCT With C-arm HyperSight Technology

No phase Interventional Advanced Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intravenous contrast-enhanced cone beam computed tomography.
Who it may be relevant to
Registry conditions: Advanced Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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 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.

Primary outcome measures

  • Feasibility of IV-contrast enhanced CBCT during image-guided radiotherapy [Time frame: 18 Months]
Secondary outcome measures (3)
  • Feasibility of dynamic-contrast-enhanced (DCE) imaging [Time frame: 18 Months]
  • Image quality of full versus half (17 s) CBCT acquisition, with and without contrast enhancement [Time frame: 18 Months]
  • Patient preferences and comfort with the use of IV CBCT during treatment [Time frame: 18 Months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Princess Margaret Cancer Center — Toronto

Identifiers

NCT: NCT07648160 · 24-5806

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗