Lung CancerNCT01018147
4D Image-guided Adaptive Radiotherapy for Lung Cancer: Patient Image Acquisition
A study testing 4-dimensional computed tomography in people with Lung Cancer, run by Virginia Commonwealth University.
Trial summary
This clinical trial studies 4-dimensional (4-D) image-guided radiation therapy treatment planning in patients with stage I-IV non-small cell lung cancer. Computed tomography (CT) scans and treatment-planning systems may help in planning radiation therapy for patients with non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- 4-dimensional computed tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Oct 2015
- 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
- Histologic or cytologic confirmation of non-small cell lung cancer stages I-IV
- Partial pressure oxygen (pO2) > 92%-obtained at the time of or within 3 months prior to initial consultation with the radiation oncologist
- Tumor(s) must be visualized on a CT
- Positron emission tomography (PET) is performed during staging or treatment planning process
- All patients must be informed on the investigational nature of this study and must give informed consent in accordance with institutional guidelines
Who cannot join
- Pregnant women may not participate; women of reproductive potential must be informed of the need to practice an effective contraceptive method
- Unstable coronary artery disease
- Uncorrectable coagulopathy
- Severe pulmonary hypertension
- Poor tolerance of conscious sedation
About this study
This clinical trial studies 4-dimensional (4-D) image-guided radiation therapy treatment planning in patients with stage I-IV non-small cell lung cancer. Computed tomography (CT) scans and treatment-planning systems may help in planning radiation therapy for patients with non-small cell lung cancer. This is not a therapy study. Therefore no direct benefit from participating is expected. However, at the discretion of the treating physician, the information gained from the additional imaging will be used to improve treatment accuracy. No patient outcome data are gathered or analyzed by this study. This study is not a:Phase I, II, or III trial, trial with "blinded" treatment arm, gene or a vaccine trial, or a multi-institutional trial.
Read the detailed description
OBJECTIVES:
- Quantify the magnitude and distribution of inter- and intrafraction anatomic variations, including the temporal stability of the tumor/respiration signal correlation.
- Improve the acquisition and reconstruction of 4D CT scan images by advancing the 4D CT scan data collection process and evaluating 4D CT scan image reconstruction using different respiratory inputs.
- Quantify the uncertainty of deformable image-registration algorithms.
- Develop and investigate the efficacy of inter- and intrafraction probabilistic planning-based 4D image-guided adaptive radiotherapy (IGART) strategies for clinical application.
- Determine the expected geometric, dosimetric, and radiobiological improvements from the 4D IGART system.
OUTLINE: Patients undergo insertion of ≥ 1 small radio-opaque marker into (or in the vicinity of) the primary lesion or suspect lymph nodes via bronchoscopy. X-rays are performed to document the position of the markers.
Patients undergo 4D CT scan before each radiotherapy session and once a week after a radiotherapy session. Patients also undergo x-ray imaging before and during radiotherapy, optical and internal marker motion recording before and after radiotherapy, and audiovisual feedback during radiotherapy.
Patients undergo image-guided adapted radiotherapy based on these data.
- Conditions
- Lung Cancer
- Being tested
- 4-dimensional computed tomography
- Keywords
- stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IA non-small cell lung cancer, stage IB non-small cell lung cancer, stage IIA non-small cell lung cancer, stage IIB non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-dimensional computed tomographyProcedure or surgery
Also called 4D-CT
Undergo 4-D CT imaging
| Study group | Role | What they receive |
|---|---|---|
| CT Imaging | Experimental | Patients undergo 4-D, 4-dimensional computed tomography, CT imaging prior to radiotherapy sessions and once a week at the end of treatment. Receives: Procedure: 4-dimensional computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
At least 1 mm reduction in overall systematic error corresponding with ≥ 2 mm CTV-PTV margin reduction
Measured: Up to 7 years
At least 5 Gy reduction in mean lung dose
Measured: up to 7 years
At least 5% reduction in absolute pneumonitis risk (≥ grade 2)
Measured: up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startSep 2006
- Primary completionApr 2012
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jeffrey F. Williamson, PhD, Principal investigator, Massey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018147
- Sponsor's protocol ID
- MCC-10395
- Other IDs
- HM-10395, CDR0000657239, NCI-2011-01700
- Status last verified
- Feb 2016
- First submitted
- 20 Nov 2009
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4D Image-guided Adaptive Radiotherapy for Lung Cancer: Patient Image Acquisition
- ClinicalTrials.gov ID
- NCT01018147
- Acronym / sponsor ID
- MCC-10395
- Conditions
- Lung Cancer
- Keywords
- stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IA non-small cell lung cancer, stage IB non-small cell lung cancer, stage IIA non-small cell lung cancer, stage IIB non-small cell lung cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2006
- Primary completion
- Apr 2012 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 23 Nov 2009 (estimated)
- 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.
This clinical trial studies 4-dimensional (4-D) image-guided radiation therapy treatment planning in patients with stage I-IV non-small cell lung cancer. Computed tomography (CT) scans and treatment-planning systems may help in planning radiation therapy for patients with non-small cell lung cancer. This is not a therapy study. Therefore no direct benefit from participating is expected. However, at the discretion of the treating physician, the information gained from the additional imaging will be used to improve treatment accuracy. No patient outcome data are gathered or analyzed by this study. This study is not a:Phase I, II, or III trial, trial with "blinded" treatment arm, gene or a vaccine trial, or a multi-institutional trial.
Detailed description
OBJECTIVES:
- Quantify the magnitude and distribution of inter- and intrafraction anatomic variations, including the temporal stability of the tumor/respiration signal correlation.
- Improve the acquisition and reconstruction of 4D CT scan images by advancing the 4D CT scan data collection process and evaluating 4D CT scan image reconstruction using different respiratory inputs.
- Quantify the uncertainty of deformable image-registration algorithms.
- Develop and investigate the efficacy of inter- and intrafraction probabilistic planning-based 4D image-guided adaptive radiotherapy (IGART) strategies for clinical application.
- Determine the expected geometric, dosimetric, and radiobiological improvements from the 4D IGART system.
OUTLINE: Patients undergo insertion of ≥ 1 small radio-opaque marker into (or in the vicinity of) the primary lesion or suspect lymph nodes via bronchoscopy. X-rays are performed to document the position of the markers.
Patients undergo 4D CT scan before each radiotherapy session and once a week after a radiotherapy session. Patients also undergo x-ray imaging before and during radiotherapy, optical and internal marker motion recording before and after radiotherapy, and audiovisual feedback during radiotherapy.
Patients undergo image-guided adapted radiotherapy based on these data.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT Imaging | Experimental | Procedure: 4-dimensional computed tomographyPatients undergo 4-D, 4-dimensional computed tomography, CT imaging prior to radiotherapy sessions and once a week at the end of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologic or cytologic confirmation of non-small cell lung cancer stages I-IV
- Partial pressure oxygen (pO2) > 92%-obtained at the time of or within 3 months prior to initial consultation with the radiation oncologist
- Tumor(s) must be visualized on a CT
- Positron emission tomography (PET) is performed during staging or treatment planning process
- All patients must be informed on the investigational nature of this study and must give informed consent in accordance with institutional guidelines
Key exclusion criteria (5 listed)
- Pregnant women may not participate; women of reproductive potential must be informed of the need to practice an effective contraceptive method
- Unstable coronary artery disease
- Uncorrectable coagulopathy
- Severe pulmonary hypertension
- Poor tolerance of conscious sedation
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 |
|---|---|---|
| 4-dimensional computed tomographyAlso: 4D-CTUndergo 4-D CT imaging | Procedure or surgery | CT Imaging |
Primary outcome
At least 1 mm reduction in overall systematic error corresponding with ≥ 2 mm CTV-PTV margin reduction
Time frame: Up to 7 years
At least 5 Gy reduction in mean lung dose
Time frame: up to 7 years
At least 5% reduction in absolute pneumonitis risk (≥ grade 2)
Time frame: up to 7 years
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 8 Feb 2016.
- published articleLink provided by the sponsor.
- published articleLink provided by the sponsor.
- published articleLink provided by the sponsor.
- This article has been featured in: http://biomedfrontiers.org/cancer-2014-2-4/Link provided by the sponsor.
- published articleLink provided by the sponsor.
- published articleLink provided by the sponsor.
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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.
Jeffrey F. Williamson, PhD principal investigator
Massey Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing 4-dimensional computed tomography in people with Lung Cancer, run by Virginia Commonwealth University.
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 5 inclusion and 5 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 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
At least 1 mm reduction in overall systematic error corresponding with ≥ 2 mm CTV-PTV margin reduction (time frame: Up to 7 years). The study lists 3 primary outcomes in all. 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 8 Feb 2016.