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

Early Phase 1

Terminated

• Conditions: Abdominal Cancer; Pelvic Cancer
• Interventions: Drug: Omnipaque 300mg/mL Solution for Injection; Radiation: Cone Beam CT; Radiation: Radiation Therapy; Drug: 0.9% Saline

• Registration Number: NCT04199754
• Lead Sponsor: Columbia University

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-16
• Study Start: 2020-10-01
• Primary Completion: 2021-05-28
• Study Completion: 2021-05-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-05-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1. Subject must be greater than or equal to 18 years of age.
2. Subject must be able and willing to sign a written informed consent document.
3. Subject requiring image-guided external beam radiotherapy to abdominal or pelvic tumor with cone beam CT deemed clinically necessary by the treating physician.
4. No history of prior allergic reaction to intravenous CT contrast medium.
5. Creatinine of less than 1.9 mg/dL measured within one month prior to enrollment on the study.
6. No administration of intravenous contrast within 24 hours of administration of intravenous contrast on protocol.
7. Ability to complete New York Presbyterian Hospital iodinated contrast media administration questionnaire.
8. Negative pregnancy test for females of childbearing potential, in accordance to institutional guidelines.
9. Ability to fast for at least 2 hours prior to study procedures.
10. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3.

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Exclusion Criteria

1. Known allergy to iohexol or any iodinated intravenous contrast medium.
2. Fluid overload that would contraindicate bolus administration of intravenous contrast.
3. Pregnant or nursing subjects.
4. Presence of single kidney or transplanted kidney
5. Acute renal failure
6. Chronic renal insufficiency, stage IV or V.
7. Administration of iodinated intravenous CT contrast medium within 24 hours of study procedures.
8. Inability to fast for at least 2 hours prior to study procedures.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Contrast Enhanced Cone Beam CT	Radiation Therapy	60 seconds after the start of the administration of IV contrast, cone beam CT will be initiated.
Contrast Enhanced Cone Beam CT	0.9% Saline	60 seconds after the start of the administration of IV contrast, cone beam CT will be initiated.
Contrast Enhanced Cone Beam CT	Omnipaque 300mg/mL Solution for Injection	60 seconds after the start of the administration of IV contrast, cone beam CT will be initiated.
Contrast Enhanced Cone Beam CT	Cone Beam CT	60 seconds after the start of the administration of IV contrast, cone beam CT will be initiated.

Primary Outcome Measures

Name	Time	Method
Physician Survey of attitude about the utility of contrast-enhanced cone beam CT	Up to 18 Months	The Radiation Oncologist treating physician will complete a physician survey using a Likert scale regarding attitude about the utility of contrast enhanced cone beam CT.
Blinded Match between contrast and non-contrast enhanced CBCT	Up to 18 Months	After completion of study procedures of all enrolled subjects, images from both contrast-enhanced and non-contrast cone beam CT will undergo blinded matching by two additional study physicians. The magnitude of proposed shifts (measured in millimeters in x-, y- and z- axes) for each cone beam CT will be recorded and interrater reliability will be assessed for concordance.

Trial Locations

Locations (1)

Columbia University Irving Medical Center/Department of Radiation Oncology; 🇺🇸 New York, New York, United States