IV Contrast-Enhanced Cone Beam Computed Tomography (CBCT) in Radiotherapy
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| ClinicalTrials.gov Identifier: NCT04199754 |
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Recruitment Status :
Recruiting
First Posted : December 16, 2019
Last Update Posted : April 20, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pelvic Cancer Abdominal Cancer | Drug: Omnipaque 300mg/mL Solution for Injection Radiation: Cone Beam CT Radiation: Radiation Therapy Drug: 0.9% Saline | Early Phase 1 |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 15 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Subjects will receive contrast enhanced CBCT prior to RT treatment. |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Pilot Study of Intravenous Contrast-Enhanced Cone Beam Computed Tomography (CT) in Patients Receiving Radiotherapy |
| Actual Study Start Date : | October 1, 2020 |
| Estimated Primary Completion Date : | December 31, 2023 |
| Estimated Study Completion Date : | December 31, 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Contrast Enhanced Cone Beam CT
60 seconds after the start of the administration of IV contrast, cone beam CT will be initiated.
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Drug: Omnipaque 300mg/mL Solution for Injection
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 Name: Iohexol Radiation: Cone Beam CT 60 seconds after contrast administration, a Cone Beam CT will be performed. Radiation: Radiation Therapy Standard of Care Radiation Therapy will be administered, dosage depends on the type of tumor being treated. Drug: 0.9% Saline 50 ML of 0.9% Saline will be administered immediately after Omnipaque administration
Other Name: Saline Solution |
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04199754
| Contact: David Horowitz, MD | 212-305-5050 | dph2119@cumc.columbia.edu | |
| Contact: Mariamne Reyna | 646-317-4244 | mo2213@cumc.columbia.edu |
| United States, New York | |
| Columbia University Irving Medical Center/Department of Radiation Oncology | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: David Horowitz, MD 212-305-5050 dph2119@cumc.columbia.edu | |
| Contact: Mariamne Reyna 646-317-4244 mo2213@cumc.columbia.edu | |
| Principal Investigator: David Horowitz, MD | |
| Principal Investigator: | David Horowitz, MD | Assistant Professor of Radiation Oncology at Columbia University Medical Center |
| Responsible Party: | David P. Horowitz, M.D., Assistant Professor of Radiation Oncology, Columbia University |
| ClinicalTrials.gov Identifier: | NCT04199754 |
| Other Study ID Numbers: |
AAAS0632 |
| First Posted: | December 16, 2019 Key Record Dates |
| Last Update Posted: | April 20, 2023 |
| Last Verified: | April 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
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CBCT- Cone Beam CT |
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Pelvic Neoplasms Neoplasms by Site Neoplasms Pharmaceutical Solutions |