TerminatedEarly Phase 1

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

Stopped: Slow accrual rate due to national contrast shortage

United States6 participantsStarted 2020-10-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Physician Survey of attitude about the utility of contrast-enhanced cone beam CT

Timeframe: Up to 18 Months

Blinded Match between contrast and non-contrast enhanced CBCT

Timeframe: Up to 18 Months

Trial details

NCT IDNCT04199754

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-28

View on ClinicalTrials.gov More Pelvic Cancer trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria