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

Sponsor
Columbia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04199754
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
39
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Omnipaque 300mg/mL Solution for Injection
  • Radiation: Cone Beam CT
  • Radiation: Radiation Therapy
  • Drug: 0.9% Saline
 Early Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Subjects will receive contrast enhanced CBCT prior to RT treatment.Subjects will receive contrast enhanced CBCT prior to RT treatment.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Pilot Study of Intravenous Contrast-Enhanced Cone Beam Computed Tomography (CT) in Patients Receiving Radiotherapy
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Contrast Enhanced Cone Beam CT

60 seconds after the start of the administration of IV contrast, cone beam CT will be initiated.

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.
Other Names:
  • Iohexol

    • 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

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Columbia University Irving Medical Center/Department of Radiation Oncology New York New York United States 10032

    Sponsors and Collaborators

    • Columbia University

    Investigators

    • Principal Investigator: David Horowitz, MD, Assistant Professor of Radiation Oncology at Columbia University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    David P. Horowitz, M.D., Assistant Professor of Radiation Oncology, Columbia University
    ClinicalTrials.gov Identifier:
    NCT04199754
    Other Study ID Numbers:
    • AAAS0632
    First Posted:
    Dec 16, 2019
    Last Update Posted:
    Mar 8, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by David P. Horowitz, M.D., Assistant Professor of Radiation Oncology, Columbia University
    CBCT- Cone Beam CT
    Additional relevant MeSH terms:
    Pelvic Neoplasms

    Study Results

    No Results Posted as of Mar 8, 2022