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

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University

Criteria

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.