Clinical trial · Interventional
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
NCT04199754CI-TRIAL-00077616terminatedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual rate due to national contrast shortage
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal Cancer | Malignant Abdominal Neoplasm | ALIAS | 0.90 |
| Pelvic Cancer | Malignant Pelvic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 0.9% Saline | Drug | — | UNRESOLVED |
| Cone Beam CT | Radiation | — | UNRESOLVED |
| Omnipaque 300mg/mL Solution for Injection | Drug | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Contrast Enhanced Cone Beam CT
- description
- 60 seconds after the start of the administration of IV contrast, cone beam CT will be initiated.
- interventionNames
- Drug: Omnipaque 300mg/mL Solution for Injection
- Radiation: Cone Beam CT
- Radiation: Radiation Therapy
- Drug: 0.9% Saline
Primary outcomes (2)
- measure
- Physician Survey of attitude about the utility of contrast-enhanced cone beam CT
- timeFrame
- Up to 18 Months
- 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.
- measure
- Blinded Match between contrast and non-contrast enhanced CBCT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (7)
- BACKGROUNDKatz 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
- BACKGROUNDMurphy 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
- BACKGROUNDKrishnan 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
- BACKGROUNDCrane 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
- BACKGROUNDJones 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
- BACKGROUNDKlostranec 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.