Lung CancerNCT02308709
Novel Lung Functional Imaging for Personalized Radiotherapy
A study testing Ventilation image-guided radiotherapy in people with Lung Cancer, run by University of California, Davis at 1 site in United States.
Trial summary
The primary objective of this study is to assess the safety and feasibility of personalized radiotherapy with four-dimensional (4D) computed tomography (CT)-based pulmonary ventilation imaging, which selectively avoids irradiating highly-functional lung regions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Ventilation image-guided radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2014to 19 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary lung cancer or metastatic disease to the lungs to be treated with either conventionally-fractionated radiotherapy (CFRT) or hypo-fractionated stereotactic ablative radiotherapy (SABR).
- Age restriction and/or gender/ethnic restrictions: Patients must be ≥18 years of age. There are no gender or ethnic restrictions.
- Concurrent chemotherapy is allowed, but not required.
- Life expectancy with treatment should be ≥6 months in the estimation of the treating physicians.
- Zubrod performance status ≤2
- Adequate marrow and hepatic function defined as Hgb ≥8; platelets ≥100k; ANC≥1500; LFTs ≤2x upper limit of normal and creatinine ≤1.3 or creatinine clearance of ≥50
- Patient must be able to provide study specific informed consent prior to study entry.
Who cannot join
- Prior radiotherapy for thoracic cancer or other malignancy leading to any overlap of planned radiotherapy fields.
- For patients undergoing definitive CFRT, patients with distant metastatic disease are not eligible.
- For patients undergoing SABR, both early stage primary lung cancer patients and those with limited metastatic disease to the lungs are eligible; however, patients with oligometastatic disease should have a controlled primary and no more than one other involved organ system.
- Children (<18 years of age), pregnant women, University of California employees or students, or prisoners will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Medical Center
Sacramento, California, 95817
About this study
The primary objective of this study is to assess the safety and feasibility of personalized radiotherapy with four-dimensional (4D) computed tomography (CT)-based pulmonary ventilation imaging, which selectively avoids irradiating highly-functional lung regions.
Read the detailed description
In this clinical trial, the investigators will assess the safety and feasibility of 4D CT ventilation image-guided personalized radiotherapy. The investigators will deliver personalized radiotherapy treatments that selectively avoid irradiating highly-functional lung regions for lung cancer patients, and follow up patients to assess the safety and feasibility. The primary hypothesis to be tested is: 4D CT ventilation image-guided personalized radiotherapy can be delivered safely for lung cancer.
- Conditions
- Lung Cancer
- Being tested
- Ventilation image-guided radiotherapy
- Keywords
- Radiotherapy, Pulmonary Functional Imaging, Computed Tomography (CT), Image Registration, Functional Image-guided Radiotherapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilation image-guided radiotherapyRadiation
Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions
| Study group | Role | What they receive |
|---|---|---|
| Ventilation image-guided radiotherapy | Experimental | Patients will receive 4D CT ventilation image-guided personalized radiotherapy treatment that selectively avoids irradiating highly-functional lung regions Receives: Radiation: Ventilation image-guided radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade ≥3 AEs Defined as Definitely, Probably, or Possibly Related to 4D CT Ventilation Image-guided Personalized Radiotherapy
Number of subjects experiencing Grade ≥3 AEs, i.e., Grade ≥3 radiation pneumonitis, grade ≥3 esophagitis, or other grade ≥3 AEs, defined as definitely, probably, or possibly related to 4D CT ventilation image-guided personalized radiotherapy.
Measured: 12 months
Secondary outcomes (3)
Radiation Pneumonitis Graded by CTCAE v4.0
Number of participants with Grade ≥ 2 radiation pneumonitis adverse event graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Measured: 2 years
Post-treatment Change in Forced Expiratory Volume in 1 Second (FEV1)
The median absolute change from baseline in FEV1 (% predicted) at 6 months after treatment.
Measured: Baseline and 6 months
Post-treatment Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
The median absolute change from baseline in DLCO (% predicted) at 6 months after treatment.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study start15 Sep 2014
- Primary completion19 Nov 2020
- Study completion19 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tokihiro Yamamoto, Ph.D, University of California, Davis
- Investigators
- Tokihiro Yamamoto, Ph.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308709
- Sponsor's protocol ID
- 472677
- Other IDs
- CCRO030
- Status last verified
- Oct 2022
- First submitted
- 3 Nov 2014
- Last updated
- 10 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Lung Functional Imaging for Personalized Radiotherapy
- ClinicalTrials.gov ID
- NCT02308709
- Acronym / sponsor ID
- 472677
- Conditions
- Lung Cancer
- Keywords
- Radiotherapy, Pulmonary Functional Imaging, Computed Tomography (CT), Image Registration, Functional Image-guided Radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 15 Sep 2014 (actual)
- Primary completion
- 19 Nov 2020 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Posted 10 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the safety and feasibility of personalized radiotherapy with four-dimensional (4D) computed tomography (CT)-based pulmonary ventilation imaging, which selectively avoids irradiating highly-functional lung regions.
Detailed description
In this clinical trial, the investigators will assess the safety and feasibility of 4D CT ventilation image-guided personalized radiotherapy. The investigators will deliver personalized radiotherapy treatments that selectively avoid irradiating highly-functional lung regions for lung cancer patients, and follow up patients to assess the safety and feasibility. The primary hypothesis to be tested is: 4D CT ventilation image-guided personalized radiotherapy can be delivered safely for lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ventilation image-guided radiotherapy | Experimental | Radiation: Ventilation image-guided radiotherapyPatients will receive 4D CT ventilation image-guided personalized radiotherapy treatment that selectively avoids irradiating highly-functional lung regions |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Primary lung cancer or metastatic disease to the lungs to be treated with either conventionally-fractionated radiotherapy (CFRT) or hypo-fractionated stereotactic ablative radiotherapy (SABR).
- Age restriction and/or gender/ethnic restrictions: Patients must be ≥18 years of age. There are no gender or ethnic restrictions.
- Concurrent chemotherapy is allowed, but not required.
- Life expectancy with treatment should be ≥6 months in the estimation of the treating physicians.
- Zubrod performance status ≤2
Key exclusion criteria (4 listed)
- Prior radiotherapy for thoracic cancer or other malignancy leading to any overlap of planned radiotherapy fields.
- For patients undergoing definitive CFRT, patients with distant metastatic disease are not eligible.
- For patients undergoing SABR, both early stage primary lung cancer patients and those with limited metastatic disease to the lungs are eligible; however, patients with oligometastatic disease should have a controlled primary and no more than one other involved organ system.
- Children (<18 years of age), pregnant women, University of California employees or students, or prisoners will be excluded from this study.
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 |
|---|---|---|
| Ventilation image-guided radiotherapyPatient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions | Radiation | Ventilation image-guided radiotherapy |
Primary outcome
Grade ≥3 AEs Defined as Definitely, Probably, or Possibly Related to 4D CT Ventilation Image-guided Personalized Radiotherapy
Time frame: 12 months
Number of subjects experiencing Grade ≥3 AEs, i.e., Grade ≥3 radiation pneumonitis, grade ≥3 esophagitis, or other grade ≥3 AEs, defined as definitely, probably, or possibly related to 4D CT ventilation image-guided personalized radiotherapy.
3 secondary outcomes
Radiation Pneumonitis Graded by CTCAE v4.0
Time frame: 2 years
Post-treatment Change in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline and 6 months
Post-treatment Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Tokihiro Yamamoto, Ph.D. principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilation image-guided radiotherapy in people with Lung Cancer, run by University of California, Davis 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 7 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 10 Nov 2022. 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. 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?
Yes. Results are posted in the registry (first posted 10 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Grade ≥3 AEs Defined as Definitely, Probably, or Possibly Related to 4D CT Ventilation Image-guided Personalized Radiotherapy (time frame: 12 months). 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 10 Nov 2022.