- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04717804
4D CBCT and Intrafractional Imaging for the Determination of the Most Representative 4D Simulation Planning Technique for Lung SBRT Technique Patients
August 22, 2023 updated by: Daniel Saenz, The University of Texas Health Science Center at San Antonio
4D(Dimensional) CBCT (Cone-beam Computed Tomography) and Intrafractional Imaging for the Determination of the Most Representative 4D Simulation Planning Technique for Lung SBRT (Stereotactic Body Radiation Therapy) Technique Patients
The researchers plan to investigate two ways of visualizing and planning to account for the respiratory motion which takes place while treating lung tumors with radiation therapy.
The researchers will determine if a traditional snapshot (free-breathing) CT or a longer-lasting CT encompassing the breathing cycle better matches a patient's breathing during treatment.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
As part of this study the patient will receive the standard of care treatment of Stereotactic Body Radiation Therapy (SBRT) approach for treatment of lung cancer.
The study will compare whether the quick snapshot or longer-last image is more representative of breathing motion.
The standard of care way to verify breathing is to use the Cone Beam Computerized Tomography (CBCT) before each treatment.
For this study the researchers will use two other standard of care ways to verify breathing motion during treatment only during the first and last radiation treatment sessions.
During the other radiation treatment sessions the CBCT alone will be used.
These two other methods are FDA approved, but not routinely being used at the Mays Cancer Center.
One method is called 4D-CBCT and is conducted immediately prior to treatment.
This will create an image taken over a longer time of the patient's lungs which will be compared with the images from the CT Simulation used to plan the radiation.
The other way is called Intrafractional CBCT and is imaging that is done at the same time as the radiation treatment delivery.
This will show the researchers how the tumor is moving while the radiation treatment is taking place.
These two methods require a longer treatment time, approximately 10 minutes during the first and last treatments.
Study Type
Interventional
Enrollment (Estimated)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Carol Jenkins, RN, MSN
- Phone Number: 210-450-5924
- Email: jenkinsca@uthscsa.edu
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78229
- Recruiting
- Mays Cancer Center, UT Health San Antonio
-
Contact:
- Carol Jenkins, RN, MSN
- Phone Number: 210-450-5924
- Email: jenkinsca@uthscsa.edu
-
Contact:
- Daniel Saenz, PhD
- Phone Number: 210-450-1023
- Email: saenzdl@uthscsa.edu
-
Principal Investigator:
- Daniel Saenz, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥ 18 years.
- Ability to provide informed written consent in either English or Spanish.
- Patients with cancer or presumed cancer involving the lung (primary or secondary) planned to undergo lung SBRT technique or IMRT technique with an SBRT setup in 10 or fewer fractions.
Exclusion Criteria:
- Current pregnancy, as this is a contraindication to receiving radiation therapy.
- Patients to be treated to multiple targets concurrently.
- Any condition or history as evidenced by patient record and/or self-report that, in the opinion of the investigator, would interfere with adherence to the prescribed pattern of radiation therapy.
- Poor lung function, as judged by the prescribing radiation oncologist, sufficiently limiting to make the patient not a candidate for 4D imaging (for example major differences between the 4D and free-breathing CT scan).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: AIP (Average Intensity Projection) CT (Computed Tomagraphy)
An image taken over a longer time of the lungs (average intensity projection of 4DCT) will be compared with breathing during treatment.
|
An image taken over a longer time of the lungs (average intensity projection of 4DCT) will be compared with breathing during treatment.
Other Names:
|
Placebo Comparator: FB (Free-Breathing) CT
A snapshot of breathing (free-breathing traditional CT) will be used to compare with breathing during treatment.
|
A snapshot of breathing (free-breathing traditional CT) will be used to compare with breathing during treatment.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To investigate radiation therapy treatment tumor localization accuracy by determining whether the FB or AIP images is more representative of the target at treatment.
Time Frame: 2 weeks
|
This will be quantitively determined by quantifying the agreement between the two CT scans using the Dice coefficient (DSC) as a metric for localization accuracy.
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Daniel Saenz, PhD, UT Health San Antonio
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 17, 2021
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
May 1, 2025
Study Registration Dates
First Submitted
January 11, 2021
First Submitted That Met QC Criteria
January 15, 2021
First Posted (Actual)
January 22, 2021
Study Record Updates
Last Update Posted (Actual)
August 24, 2023
Last Update Submitted That Met QC Criteria
August 22, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTMS# 20-0107
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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