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Contrast-Enhanced CBCT for Abdominal/Pelvic Cancer
Phase < 1
Recruiting
Led By David Horowitz, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3
Subject requiring image-guided external beam radiotherapy to abdominal or pelvic tumor with cone beam CT deemed clinically necessary by the treating physician
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights
Study Summary
This trial is testing whether adding IV contrast to a CBCT scan can improve outcomes for people receiving IGRT for abdominal/pelvic tumors.
Who is the study for?
This trial is for adults over 18 needing image-guided radiotherapy for abdominal or pelvic tumors, with proper kidney function (creatinine <1.9 mg/dL), no recent IV contrast use, and no severe allergies to CT contrast media. Pregnant or nursing individuals, those with advanced kidney disease, single/transplanted kidneys, or inability to fast are excluded.Check my eligibility
What is being tested?
The study tests if using IV contrast during CBCT scans improves imaging for guiding radiation therapy in treating abdominal/pelvic tumors. Participants will receive a saline solution and Omnipaque injection before undergoing enhanced CBCT as part of their treatment planning.See study design
What are the potential side effects?
Potential side effects include allergic reactions to the IV contrast used in the scan (Omnipaque), such as itching or rash; kidney function changes due to the contrast agent; and discomfort from fasting required before procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself but may not be able to do heavy physical work.
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My doctor says I need special radiation for my abdominal or pelvic tumor.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blinded Match between contrast and non-contrast enhanced CBCT
Physician Survey of attitude about the utility of contrast-enhanced cone beam CT
Trial Design
1Treatment groups
Experimental Treatment
Group I: Contrast Enhanced Cone Beam CTExperimental Treatment4 Interventions
60 seconds after the start of the administration of IV contrast, cone beam CT will be initiated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
0.9% Saline
2011
Completed Phase 4
~32970
Radiation Therapy
2017
Completed Phase 3
~7250
Cone Beam CT
2009
N/A
~160
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,433 Previous Clinical Trials
2,447,244 Total Patients Enrolled
David Horowitz, MDPrincipal InvestigatorAssistant Professor of Radiation Oncology at Columbia University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can care for myself but may not be able to do heavy physical work.I have not had a CT scan with dye within the last 24 hours.My kidney function is severely reduced.I have only one kidney or a transplanted kidney.I am not pregnant or have confirmed it with a test if capable of becoming pregnant.I am currently experiencing acute kidney failure.My latest kidney test shows creatinine below 1.9 mg/dL.You are allergic to iohexol or any other liquid used for contrast in scans.You have never had an allergic reaction to a special dye used for intravenous scans.My doctor says I need special radiation for my abdominal or pelvic tumor.I am 18 years old or older.I cannot receive IV contrast due to fluid overload.
Research Study Groups:
This trial has the following groups:- Group 1: Contrast Enhanced Cone Beam CT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any precedential studies regarding the efficacy of Radiation Therapy?
"Presently, 10 clinical trials related to Radiation Therapy are still in progress with none at Phase 3. Notably, there is a concentration of these studies held in Joplin, Missouri and 173 other sites across the country conducting tests for this medical intervention."
Answered by AI
Does this research initiative currently accept participants?
"Affirmative. According to clinicaltrials.gov, this medical trial has been open for recruitment since October 1st 2020 and was recently updated on March 7th 2022. The study seeks 15 individuals from a single participating centre."
Answered by AI
What is the enrollment rate for this clinical trial?
"Affirmative, the latest update available on clinicaltrials.gov shows that this investigation is actively recruiting participants; it was initially posted back in October 2020 and edited as recently as March 2022. Specifically, 15 individuals across a single site are being recruited into the trial."
Answered by AI
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