Study Summary
This trial is testing whether adding IV contrast to a CBCT scan can improve outcomes for people receiving IGRT for abdominal/pelvic tumors.
Eligible Conditions
- Cancer of the Pelvis
- Abdominal Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 0 Secondary · Reporting Duration: Up to 18 Months
Up to 18 Months
Blinded Match between contrast and non-contrast enhanced CBCT
Physician Survey of attitude about the utility of contrast-enhanced cone beam CT
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Contrast Enhanced Cone Beam CT
1 of 1
Experimental Treatment
15 Total Participants · 1 Treatment Group
Primary Treatment: Radiation Therapy · No Placebo Group · Phase < 1
Contrast Enhanced Cone Beam CTExperimental Group · 4 Interventions: 0.9% Saline, Radiation Therapy, Cone Beam CT, Omnipaque 300mg/mL Solution for Injection · Intervention Types: Drug, Radiation, Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
0.9% Saline
2011
Completed Phase 4
~32930
Radiation Therapy
2005
Completed Phase 3
~7010
Cone Beam CT
2009
N/A
~160
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 18 months
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,295 Previous Clinical Trials
1,613,256 Total Patients Enrolled
David Horowitz, MDPrincipal InvestigatorAssistant Professor of Radiation Oncology at Columbia University Medical Center
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Creatinine level of less than 1.9 mg/dL measured within one month prior to enrollment on the study.
You are 18 years of age or older.\n
You are able and willing to sign a written informed consent document.
You have no history of a prior allergic reaction to intravenous contrast medium.
You are able to complete the iodinated contrast media administration questionnaire.
You are of childbearing potential.
You are able to fast for at least 2 hours prior to study procedures.
You have a performance status of 0-3.
References
- Katz, Matthew H. G., for the Alliance for Clinical Trials on Oncology, Fang-Shu Ou, Joseph M. Herman, Syed A. Ahmad, Brian Wolpin, Robert Marsh, et al.. 2017. “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. Springer Science and Business Media LLC. doi:10.1186/s12885-017-3441-z.
- Murphy, James D., Saroja Adusumilli, Kent A. Griffith, Michael E. Ray, Mark M. Zalupski, Theodore S. Lawrence, and Edgar Ben-Josef. 2007. “Full-dose Gemcitabine and Concurrent Radiotherapy for Unresectable Pancreatic Cancer”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/j.ijrobp.2006.12.053.
- Krishnan, Sunil, Awalpreet S. Chadha, Yelin Suh, Hsiang-Chun Chen, Arvind Rao, Prajnan Das, Bruce D. Minsky, et al.. 2016. “Focal Radiation Therapy Dose Escalation Improves Overall Survival in Locally Advanced Pancreatic Cancer Patients Receiving Induction Chemotherapy and Consolidative Chemoradiation”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/j.ijrobp.2015.12.003.
- Jones, B, C Altunbas, B Kavanagh, and M Miften. 2012. “WE-G-217BCD-08: Image Quality Effects of Dynamic Iodine Concentrations for Contrast-enhanced Cone-beam CT”. Medical Physics. Wiley. doi:10.1118/1.4736216.
- Klostranec, Jesse M., Tina Ehtiati, Swati Rao, and Martin G. Radvany. 2013. “Comparison of Aortic Arch and Intravenous Contrast Injection Techniques for C-arm Cone Beam CT”. Academic Radiology. Elsevier BV. doi:10.1016/j.acra.2012.10.008.
- Eccles, Cynthia L., Regina V. Tse, Maria A. Hawkins, Mark T. Lee, Douglas J. Moseley, and Laura A. Dawson. 2016. “Intravenous Contrast-enhanced Cone Beam Computed Tomography (IVCBCT) of Intrahepatic Tumors and Vessels”. Advances in Radiation Oncology. Elsevier BV. doi:10.1016/j.adro.2016.01.001.
- Crane, Christopher H.. 2016. “Hypofractionated Ablative Radiotherapy for Locally Advanced Pancreatic Cancer”. Journal of Radiation Research. Oxford University Press (OUP). doi:10.1093/jrr/rrw016.
- 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.
- 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.
- David P. Horowitz, M.D. 2020. "IV Contrast-Enhanced Cone Beam Computed Tomography (CBCT) in Radiotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04199754.
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Conditions
Cancer Related
Treatments