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4D CBCT and Intrafractional Imaging for the Determination of the Most Representative 4D Simulation Planning Technique for Lung SBRT Technique Patients

Primary Purpose

Cancer of Lung

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AIP CT
FB (Free-Breathing) CT
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cancer of Lung

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Mays Cancer Center, UT Health San AntonioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

AIP (Average Intensity Projection) CT (Computed Tomagraphy)

FB (Free-Breathing) CT

Arm Description

An image taken over a longer time of the lungs (average intensity projection of 4DCT) will be compared with breathing during treatment.

A snapshot of breathing (free-breathing traditional CT) will be used to compare with breathing during treatment.

Outcomes

Primary Outcome Measures

To investigate radiation therapy treatment tumor localization accuracy by determining whether the FB or AIP images is more representative of the target at treatment.
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.

Secondary Outcome Measures

Full Information

First Posted
January 11, 2021
Last Updated
August 22, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
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1. Study Identification

Unique Protocol Identification Number
NCT04717804
Brief Title
4D CBCT and Intrafractional Imaging for the Determination of the Most Representative 4D Simulation Planning Technique for Lung SBRT Technique Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Lung

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AIP (Average Intensity Projection) CT (Computed Tomagraphy)
Arm Type
Active Comparator
Arm Description
An image taken over a longer time of the lungs (average intensity projection of 4DCT) will be compared with breathing during treatment.
Arm Title
FB (Free-Breathing) CT
Arm Type
Placebo Comparator
Arm Description
A snapshot of breathing (free-breathing traditional CT) will be used to compare with breathing during treatment.
Intervention Type
Other
Intervention Name(s)
AIP CT
Other Intervention Name(s)
CT Imaging
Intervention Description
An image taken over a longer time of the lungs (average intensity projection of 4DCT) will be compared with breathing during treatment.
Intervention Type
Other
Intervention Name(s)
FB (Free-Breathing) CT
Other Intervention Name(s)
CT Imaging
Intervention Description
A snapshot of breathing (free-breathing traditional CT) will be used to compare with breathing during treatment.
Primary Outcome Measure Information:
Title
To investigate radiation therapy treatment tumor localization accuracy by determining whether the FB or AIP images is more representative of the target at treatment.
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carol Jenkins, RN, MSN
Phone
210-450-5924
Email
jenkinsca@uthscsa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Saenz, PhD
Organizational Affiliation
UT Health San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mays Cancer Center, UT Health San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carol Jenkins, RN, MSN
Phone
210-450-5924
Email
jenkinsca@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Daniel Saenz, PhD
Phone
210-450-1023
Email
saenzdl@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Daniel Saenz, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

4D CBCT and Intrafractional Imaging for the Determination of the Most Representative 4D Simulation Planning Technique for Lung SBRT Technique Patients

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