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

NCT04199754 | Terminated Early Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: AAAS0632
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Cancer; Abdominal Cancer

Keywords

CBCT- Cone Beam CT

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 18 Months

• 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.

  Up to 18 Months

Study Arms (1)

Contrast Enhanced Cone Beam CT

EXPERIMENTAL

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

Drug: Omnipaque 300mg/mL Solution for Injection; Radiation: Cone Beam CT; Radiation: Radiation Therapy; Drug: 0.9% Saline

Interventions

Omnipaque 300mg/mL Solution for Injection DRUG

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.

Also known as: Iohexol

Contrast Enhanced Cone Beam CT

Cone Beam CT RADIATION

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

Contrast Enhanced Cone Beam CT

Radiation Therapy RADIATION

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

Contrast Enhanced Cone Beam CT

0.9% Saline DRUG

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

Also known as: Saline Solution

Contrast Enhanced Cone Beam CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center/Department of Radiation Oncology

New York, New York, 10032, United States

Location

Related Publications (7)

• 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.

  PMID: 28750659 BACKGROUND

• 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.

  PMID: 17379445 BACKGROUND

• 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.

  PMID: 26972648 BACKGROUND

• 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.

  PMID: 27029741 BACKGROUND

• 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.

  PMID: 28519608 BACKGROUND

• 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.

  PMID: 23498995 BACKGROUND

• 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.

  PMID: 28740872 BACKGROUND

MeSH Terms

Conditions

Pelvic Neoplasms

Interventions

Iohexol; Solutions; Injections; Radiotherapy; Saline Solution

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics; Crystalloid Solutions; Isotonic Solutions

Study Officials

• David Horowitz, MD

  Assistant Professor of Radiation Oncology at Columbia University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiation Oncology

Model Details: Subjects will receive contrast enhanced CBCT prior to RT treatment.

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 16, 2019
• Study Start: October 1, 2020
• Primary Completion: May 28, 2021
• Study Completion: May 28, 2021
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)