- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: David Horowitz, MD
- Phone Number: 212-305-5050
- Email: dph2119@cumc.columbia.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Recruiting
- Columbia University Irving Medical Center/Department of Radiation Oncology
-
Contact:
- David Horowitz, MD
- Phone Number: 212-305-5050
- Email: dph2119@cumc.columbia.edu
-
Principal Investigator:
- David Horowitz, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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:
60 seconds after contrast administration, a Cone Beam CT will be performed.
Standard of Care Radiation Therapy will be administered, dosage depends on the type of tumor being treated.
50 ML of 0.9% Saline will be administered immediately after Omnipaque administration
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physician Survey of attitude about the utility of contrast-enhanced cone beam CT
Time Frame: 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.
|
Up to 18 Months
|
Blinded Match between contrast and non-contrast enhanced CBCT
Time Frame: 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.
|
Up to 18 Months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Horowitz, MD, Assistant Professor of Radiation Oncology at Columbia University Medical Center
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAS0632
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Abdominal Cancer
-
M.D. Anderson Cancer CenterRecruitingIntra-abdominal CancerUnited States
-
Assiut UniversitySouth Egypt Cancer InstituteCompletedPostoperative Analgesia | Lower Abdominal CancerEgypt
-
Fayoum University HospitalCompleted
-
Alaa Ali Mohamed ElzohryCompletedAbdominal Cancer
-
Fundación para la Investigación del Hospital Clínico...INCLIVACompletedAbdominal CancerSpain
-
Assiut UniversityNot yet recruitingQLB in Lower Abdominal Cancer Surgeries as a Post Operative Analgesia
-
M.D. Anderson Cancer CenterWithdrawnSymptoms and Signs Involving Cognition Perception Emotion & Behaviour | Abdominal Cancer Patients
-
The Netherlands Cancer InstituteRecruiting
-
Jules Bordet InstituteCompleted
-
Assiut UniversityCompletedPain Relief in Upper Abdominal Cancer SurgeriesEgypt
Clinical Trials on Omnipaque 300mg/mL Solution for Injection
-
Alison StopeckRecruitingBreast Cancer | Triple Negative Breast Cancer | HER2-positive Breast Cancer | TNBC, Triple Negative Breast Cancer | Locally Advanced Breast Cancer | Neoadjuvant ChemotherapyUnited States
-
Mayo ClinicRegeneron PharmaceuticalsRecruiting
-
University of CologneRecruitingLocalized SclerodermaGermany
-
University of NebraskaCompletedChronic SinusitisUnited States
-
Geisinger ClinicTerminatedObesity | Diabetic Kidney Disease | Type 2 Diabetes Mellitus in Obese | CKD | Severe ObesityUnited States
-
Medical University of South CarolinaBayerCompletedCardiovascular Diseases | Coronary Artery DiseaseUnited States
-
GuerbetCompletedBlood Brain Barrier Defect | CNS LesionUnited States, Spain, Korea, Republic of, Taiwan, France, Hungary, Belgium, Germany, Italy, Mexico, Poland
-
Ferring PharmaceuticalsCompleted
-
University Medicine GreifswaldCompletedMRI | Pharmacokinetics | Liver | Drug Transporter | Gd-EOB-DTPAGermany
-
Biomedica Foscama S.p.A. Industria Chimico-FarmaceuticaNot yet recruiting