An Early Phase 1 interventional study of Omnipaque 300mg/mL Solution for Injection and Cone Beam CT in Pelvic Cancer and Abdominal Cancer, sponsored by Columbia University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-31.
Sponsored by Columbia University · Early Phase 1, Interventional, and Diagnostic
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.
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.
99 studies on the registry are indexed under Pelvic Neoplasms; 27 are open to participants now.
This study's enrollment of 6 is below the median of 42 across 64 interventional studies indexed under Pelvic Neoplasms.
Browse Pelvic Neoplasms studies →Columbia University is the lead sponsor of 1,135 studies on the registry; 195 are open to participants now.
Of its 179 completed or terminated interventional studies of FDA-regulated products, 146 (82%) have results posted.
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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
Drug page: Iohexol
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
60 seconds after contrast administration, a Cone Beam CT will be performed.
Standard of Care Radiation Therapy will be administered, dosage depends on the type of tumor being treated.
50 ML of 0.9% Saline will be administered immediately after Omnipaque administration
Also known as: Saline Solution
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.
Time frame: 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.
Time frame: Up to 18 Months
Plan to share: No
This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Iohexol · Saline Solution