Clinical trial
Pilot Study of Intravenous Contrast-Enhanced Cone Beam Computed Tomography (CT) in Patients Receiving Radiotherapy
Name
AAAS0632
Description
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.
Trial arms
Trial start
2020-10-01
Estimated PCD
2021-05-28
Trial end
2021-05-28
Status
Terminated
Phase
Early phase I
Treatment
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.
Arms:
Contrast Enhanced Cone Beam CT
Other names:
Iohexol
Cone Beam CT
60 seconds after contrast administration, a Cone Beam CT will be performed.
Arms:
Contrast Enhanced Cone Beam CT
Radiation Therapy
Standard of Care Radiation Therapy will be administered, dosage depends on the type of tumor being treated.
Arms:
Contrast Enhanced Cone Beam CT
0.9% Saline
50 ML of 0.9% Saline will be administered immediately after Omnipaque administration
Arms:
Contrast Enhanced Cone Beam CT
Other names:
Saline Solution
Size
6
Primary endpoint
Physician Survey of attitude about the utility of contrast-enhanced cone beam CT
Up to 18 Months
Blinded Match between contrast and non-contrast enhanced CBCT
Up to 18 Months
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Subjects will receive contrast enhanced CBCT prior to RT treatment.', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 6, 'type': 'ACTUAL'}}
Updated at
2024-05-31
1 organization
2 products
2 indications
Organization
Columbia UniversityProduct
OmnipaqueIndication
Pelvic CancerIndication
Abdominal CancerProduct
0.9% Saline