NCT04199754

IV Contrast-Enhanced Cone Beam Computed Tomography (CBCT) in Radiotherapy

Pilot Study of Intravenous Contrast-Enhanced Cone Beam Computed Tomography (CT) in Patients Receiving Radiotherapy

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if giving intravenous (IV) contrast (a liquid that helps with the visibility of organs and blood vessels that is given through the vein with the use of a hollow needle) during a Cone Beam Computed Tomography (CBCT- a type of computerized X-ray) can help people who have image guided radiation therapy (IGRT) for the treatment of abdominal and pelvic tumors.

Detailed description

The goal of this pilot study is to determine the feasibility and utility of administering IV contrast during a Cone Beam Computed Tomography (CBCT) in subjects who have image guided radiation therapy (IGRT) for the treatment of abdominal and pelvic tumors. Participant duration is one visit. Subjects will be required to fast for at least 2 hours prior to study procedures, as determined by the treating physician based on the site to be irradiated. An 18- to 22-gauge peripheral IV will be placed in the subject's arm prior to being brought to clinical treatment room. The patient will be placed in position for radiotherapy as per standard of care and will be connected to IV contrast injector. Standard of care IGRT techniques will be performed to confirm correct positioning. Iodinated IV contrast will be administered and the contrast enhance cone beam CT will be initiated. Treatment will then be administered with the patient in the position determined by non-contrast cone beam CT, as per standard of care. Immediately after completion of treatment of the subject, the study physician will complete physician survey of attitude about the utility of contrast-enhanced cone beam CT.

Conditions

• Pelvic Cancer
• Abdominal Cancer

Interventions

Type	Name	Description
DRUG	Omnipaque 300mg/mL Solution for Injection	Prior to the contrast enhanced Cone Beam CT, 100mL of Omnipaque will be administered by IV at a rate of 2mL per second, followed by administration of 50mL of 0.9% saline.
RADIATION	Cone Beam CT	60 seconds after contrast administration, a Cone Beam CT will be performed.
RADIATION	Radiation Therapy	Standard of Care Radiation Therapy will be administered, dosage depends on the type of tumor being treated.
DRUG	0.9% Saline	50 ML of 0.9% Saline will be administered immediately after Omnipaque administration

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-05-28
• Completion: 2021-05-28
• First posted: 2019-12-16
• Last updated: 2024-05-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study