Back to results

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

Primary Purpose

Pelvic Cancer, Abdominal Cancer

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Omnipaque 300mg/mL Solution for Injection

Cone Beam CT

Radiation Therapy

0.9% Saline

About this trial

This is an interventional diagnostic trial for Pelvic Cancer focused on measuring CBCT- Cone Beam CT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Columbia University Irving Medical Center/Department of Radiation OncologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Contrast Enhanced Cone Beam CT

Arm Description

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

Outcomes

Primary Outcome Measures

Physician Survey of attitude about the utility of contrast-enhanced cone beam CT

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04199754

First Posted

December 5, 2019

Last Updated

April 18, 2023

Sponsor

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT04199754

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2020 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

4. Oversight

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

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Cancer, Abdominal Cancer

Keywords

CBCT- Cone Beam CT

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Subjects will receive contrast enhanced CBCT prior to RT treatment.

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Contrast Enhanced Cone Beam CT

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Omnipaque 300mg/mL Solution for Injection

Other Intervention Name(s)

Iohexol

Intervention Description

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.

Intervention Type

Radiation

Intervention Name(s)

Cone Beam CT

Intervention Description

60 seconds after contrast administration, a Cone Beam CT will be performed.

Intervention Type

Radiation

Intervention Name(s)

Radiation Therapy

Intervention Description

Standard of Care Radiation Therapy will be administered, dosage depends on the type of tumor being treated.

Intervention Type

Drug

Intervention Name(s)

0.9% Saline

Other Intervention Name(s)

Saline Solution

Intervention Description

50 ML of 0.9% Saline will be administered immediately after Omnipaque administration

Primary Outcome Measure Information:

Title

Physician Survey of attitude about the utility of contrast-enhanced cone beam CT

Description

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.

Time Frame

Up to 18 Months

Title

Blinded Match between contrast and non-contrast enhanced CBCT

Description

Time Frame

Up to 18 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject must be greater than or equal to 18 years of age. Subject must be able and willing to sign a written informed consent document. Subject requiring image-guided external beam radiotherapy to abdominal or pelvic tumor with cone beam CT deemed clinically necessary by the treating physician. No history of prior allergic reaction to intravenous CT contrast medium. Creatinine of less than 1.9 mg/dL measured within one month prior to enrollment on the study. No administration of intravenous contrast within 24 hours of administration of intravenous contrast on protocol. Ability to complete New York Presbyterian Hospital iodinated contrast media administration questionnaire. Negative pregnancy test for females of childbearing potential, in accordance to institutional guidelines. Ability to fast for at least 2 hours prior to study procedures. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3. Exclusion Criteria: Known allergy to iohexol or any iodinated intravenous contrast medium. Fluid overload that would contraindicate bolus administration of intravenous contrast. Pregnant or nursing subjects. Presence of single kidney or transplanted kidney Acute renal failure Chronic renal insufficiency, stage IV or V. Administration of iodinated intravenous CT contrast medium within 24 hours of study procedures. Inability to fast for at least 2 hours prior to study procedures.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David Horowitz, MD

Phone

212-305-5050

dph2119@cumc.columbia.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Mariamne Reyna

Phone

646-317-4244

mo2213@cumc.columbia.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Horowitz, MD

Organizational Affiliation

Assistant Professor of Radiation Oncology at Columbia University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University Irving Medical Center/Department of Radiation Oncology

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Horowitz, MD

Phone

212-305-5050

dph2119@cumc.columbia.edu

First Name & Middle Initial & Last Name & Degree

Mariamne Reyna

Phone

646-317-4244

mo2213@cumc.columbia.edu

First Name & Middle Initial & Last Name & Degree

David Horowitz, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28750659

Citation

Katz MHG, Ou FS, Herman JM, Ahmad SA, Wolpin B, Marsh R, Behr S, Shi Q, Chuong M, Schwartz LH, Frankel W, Collisson E, Koay EJ, Hubbard JM, Leenstra JL, Meyerhardt J, O'Reilly E; Alliance for Clinical Trials on Oncology. Alliance for clinical trials in oncology (ALLIANCE) trial A021501: preoperative extended chemotherapy vs. chemotherapy plus hypofractionated radiation therapy for borderline resectable adenocarcinoma of the head of the pancreas. BMC Cancer. 2017 Jul 27;17(1):505. doi: 10.1186/s12885-017-3441-z.

Results Reference

background

PubMed Identifier

17379445

Citation

Murphy JD, Adusumilli S, Griffith KA, Ray ME, Zalupski MM, Lawrence TS, Ben-Josef E. Full-dose gemcitabine and concurrent radiotherapy for unresectable pancreatic cancer. Int J Radiat Oncol Biol Phys. 2007 Jul 1;68(3):801-8. doi: 10.1016/j.ijrobp.2006.12.053. Epub 2007 Mar 26.

Results Reference

background

PubMed Identifier

26972648

Citation

Krishnan S, Chadha AS, Suh Y, Chen HC, Rao A, Das P, Minsky BD, Mahmood U, Delclos ME, Sawakuchi GO, Beddar S, Katz MH, Fleming JB, Javle MM, Varadhachary GR, Wolff RA, Crane CH. Focal Radiation Therapy Dose Escalation Improves Overall Survival in Locally Advanced Pancreatic Cancer Patients Receiving Induction Chemotherapy and Consolidative Chemoradiation. Int J Radiat Oncol Biol Phys. 2016 Mar 15;94(4):755-65. doi: 10.1016/j.ijrobp.2015.12.003. Epub 2015 Dec 11.

Results Reference

background

PubMed Identifier

27029741

Citation

Crane CH. Hypofractionated ablative radiotherapy for locally advanced pancreatic cancer. J Radiat Res. 2016 Aug;57 Suppl 1(Suppl 1):i53-i57. doi: 10.1093/jrr/rrw016. Epub 2016 Mar 29.

Results Reference

background

PubMed Identifier

28519608

Citation

Jones B, Altunbas C, Kavanagh B, Miften M. WE-G-217BCD-08: Image Quality Effects of Dynamic Iodine Concentrations for Contrast-Enhanced Cone-Beam CT. Med Phys. 2012 Jun;39(6Part28):3974. doi: 10.1118/1.4736216.

Results Reference

background

PubMed Identifier

23498995

Citation

Klostranec JM, Ehtiati T, Rao S, Radvany MG. Comparison of aortic arch and intravenous contrast injection techniques for C-arm cone beam CT: implications for cerebral perfusion imaging in the angiography suite. Acad Radiol. 2013 Apr;20(4):509-18. doi: 10.1016/j.acra.2012.10.008.

Results Reference

background

PubMed Identifier

28740872

Citation

Eccles CL, Tse RV, Hawkins MA, Lee MT, Moseley DJ, Dawson LA. Intravenous contrast-enhanced cone beam computed tomography (IVCBCT) of intrahepatic tumors and vessels. Adv Radiat Oncol. 2016 Jan 26;1(1):43-50. doi: 10.1016/j.adro.2016.01.001. eCollection 2016 Jan-Mar.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs