Radiation Therapy for Cancer of the Pelvis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cancer of the Pelvis+1 MoreRadiation Therapy - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Cancer of the Pelvis
  • Abdominal Cancer

Treatment Effectiveness

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Up to 18 Months

Up to 18 Months
Blinded Match between contrast and non-contrast enhanced CBCT
Physician Survey of attitude about the utility of contrast-enhanced cone beam CT

Trial Safety

Trial Design

1 Treatment Group

Contrast Enhanced Cone Beam CT
1 of 1

Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Radiation Therapy · No Placebo Group · Phase < 1

Contrast Enhanced Cone Beam CTExperimental Group · 4 Interventions: 0.9% Saline, Radiation Therapy, Cone Beam CT, Omnipaque 300mg/mL Solution for Injection · Intervention Types: Drug, Radiation, Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
0.9% Saline
2011
Completed Phase 4
~32930
Radiation Therapy
2005
Completed Phase 3
~7010
Cone Beam CT
2009
N/A
~160

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 18 months

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,295 Previous Clinical Trials
1,613,256 Total Patients Enrolled
David Horowitz, MDPrincipal InvestigatorAssistant Professor of Radiation Oncology at Columbia University Medical Center

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Creatinine level of less than 1.9 mg/dL measured within one month prior to enrollment on the study.
You are 18 years of age or older.\n
You are able and willing to sign a written informed consent document.
You have no history of a prior allergic reaction to intravenous contrast medium.
You are able to complete the iodinated contrast media administration questionnaire.
You are of childbearing potential.
You are able to fast for at least 2 hours prior to study procedures.
You have a performance status of 0-3.
References