← Back to Search

Contrast-Enhanced CBCT for Abdominal/Pelvic Cancer

Phase < 1
Waitlist Available
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
Must not have
Chronic renal insufficiency, stage IV or V
Presence of single kidney or transplanted kidney
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights

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 below
Select...
I can care for myself but may not be able to do heavy physical work.
Select...
My doctor says I need special radiation for my abdominal or pelvic tumor.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My kidney function is severely reduced.
Select...
I have only one kidney or a transplanted kidney.
Select...
I am currently experiencing acute kidney failure.
Select...
I cannot receive IV contrast due to fluid overload.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for pelvic cancer include chemotherapy, radiation therapy, and surgery. Chemotherapy works by using drugs to kill rapidly dividing cancer cells, while radiation therapy uses high-energy rays to target and destroy cancerous tissues. Surgery involves the physical removal of tumors. Intravenous (IV) contrast is often used during imaging techniques like Cone Beam Computed Tomography (CBCT) to enhance the visibility of organs and blood vessels, which is crucial for accurate treatment planning and monitoring. For pelvic cancer patients, understanding these mechanisms helps in comprehending how each treatment targets the cancer, the importance of precise imaging for effective treatment, and the potential side effects they may experience.
The current role of radiotherapy in the management of ovarian cancer.

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,448 Previous Clinical Trials
2,531,484 Total Patients Enrolled
David Horowitz, MDPrincipal InvestigatorAssistant Professor of Radiation Oncology at Columbia University Medical Center

Media Library

Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04199754 — Phase < 1
Pelvic Cancer Research Study Groups: Contrast Enhanced Cone Beam CT
Pelvic Cancer Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT04199754 — Phase < 1
Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04199754 — Phase < 1
~1 spots leftby Jul 2025