Cancer of LungNCT04717804
4D CBCT and Intrafractional Imaging for the Determination of the Most Representative 4D Simulation Planning Technique for Lung SBRT Technique Patients
A study testing AIP CT and FB (Free-Breathing) CT in people with Cancer of Lung, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Lung
- What is being tested?
- AIP CT and FB (Free-Breathing) CT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2021to 14 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Mays Cancer Center, UT Health San Antonio
San Antonio, Texas, 78229
About this study
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
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.
Read the 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.
- Conditions
- Cancer of Lung
- Being tested
- AIP CT, FB (Free-Breathing) CT
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIP CTOther
Also called CT Imaging
An image taken over a longer time of the lungs (average intensity projection of 4DCT) will be compared with breathing during treatment.
FB (Free-Breathing) CTOther
Also called CT Imaging
A snapshot of breathing (free-breathing traditional CT) will be used to compare with breathing during treatment.
| Study group | Role | What they receive |
|---|---|---|
| AIP (Average Intensity Projection) CT (Computed Tomagraphy) | Active comparator | An image taken over a longer time of the lungs (average intensity projection of 4DCT) will be compared with breathing during treatment. Receives: Other: AIP CT |
| FB (Free-Breathing) CT | Placebo comparator | A snapshot of breathing (free-breathing traditional CT) will be used to compare with breathing during treatment. Receives: Other: FB (Free-Breathing) CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start17 Aug 2021
- Primary completion14 Nov 2023
- Study completion14 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of LungStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Saenz, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717804
- Sponsor's protocol ID
- CTMS# 20-0107
- Status last verified
- Jun 2024
- First submitted
- 11 Jan 2021
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04717804
- Acronym / sponsor ID
- CTMS# 20-0107
- Conditions
- Cancer of Lung
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIP (Average Intensity Projection) CT (Computed Tomagraphy) | Active comparator | Other: AIP CTAn image taken over a longer time of the lungs (average intensity projection of 4DCT) will be compared with breathing during treatment. |
| FB (Free-Breathing) CT | Placebo comparator | Other: FB (Free-Breathing) CTA snapshot of breathing (free-breathing traditional CT) will be used to compare with breathing during treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIP CTAlso: CT ImagingAn image taken over a longer time of the lungs (average intensity projection of 4DCT) will be compared with breathing during treatment. | Other | AIP (Average Intensity Projection) CT (Computed Tomagraphy) |
| FB (Free-Breathing) CTAlso: CT ImagingA snapshot of breathing (free-breathing traditional CT) will be used to compare with breathing during treatment. | Other | FB (Free-Breathing) CT |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Cancer of Lung
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Saenz, PhD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AIP CT and FB (Free-Breathing) CT in people with Cancer of Lung, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.