Lung CancerNCT01500876
A Feasibility Study Using Four-Dimensional CT Imaging for Primary Lung Cancer
A study testing 4D-CT pre-treatment scan in people with Lung Cancer, run by University of Louisville at 1 site in United States.
Trial summary
Eligible lung cancer patients: Undergo pre-treatment 4D-CT study for treatment planning External Beam Radiation: standard fractionation (2Gy per day) or stereotactic body radiation therapy Evaluation: Repeat 4D-CT study at 3 months and 6 months post-treatment Primary objectives: To assess pre-treatment global and… 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?
- 4D-CT pre-treatment scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 2022
- 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
- ECOG performance status 0-1
- Pathologic or clinical diagnosis of lung malignancy
- Patients must have a reproducible tidal volume sufficient for 4D-CT imaging
- Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
- Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
- Patients must provide study specific informed consent prior to study entry.
Who cannot join
- Patients with severe pulmonary dysfunction with non-reproducible tidal volumes sufficient for 4D-CT imaging.
- Pregnant women or lactating women
Trial locations and contacts
1 site in 1 country.
United States1 site
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
About this study
Official title: A Feasibility Study Using Four-Dimensional CT Imaging to Evaluate Lung Strain in Patients Treated With External Beam Radiation Therapy for Primary Lung Cancer
Eligible lung cancer patients: Undergo pre-treatment 4D-CT study for treatment planning
External Beam Radiation: standard fractionation (2Gy per day) or stereotactic body radiation therapy
Evaluation: Repeat 4D-CT study at 3 months and 6 months post-treatment
Primary objectives: To assess pre-treatment global and focal lung strain and correlate with changes post-treatment
Read the detailed description
The study will be a prospective, non-randomized, single center, trial to assess and quantify lung strain using four dimensional CT (4D-CT) treatment planning scans. Patients with newly diagnosed lung cancer will be planned using 4D-CT to assess lung and tumor motion. Standard radiation treatment plans will to delivered based on tumor stage. Patients will be reassessed both clinically and radiographically using 4D-CT imaging at 3 months and 6 months post-treatment. Following the initial imaging time points, standard surveillance will be employed with clinical assessment and imaging at 3 month intervals for the first 2 years post-treatment.
- Conditions
- Lung Cancer
- Being tested
- 4D-CT pre-treatment scan
- Keywords
- lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4D-CT pre-treatment scanRadiation
Also called planning External Beam Radiation,, 4D-CT study
Undergo pre-treatment 4D-CT study for treatment planning External Beam Radiation: standard fractionation (2Gy per day) or stereotactic body radiation therapy Evaluation: Repeat 4D-CT study at 3 months and 6 months post-treatment
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | Single Arm Receives: Radiation: 4D-CT pre-treatment scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
validate lung strain modeling using 4D-CT in a lung cancer patient population to correlate pre-treatment strain with post-treatment changes.
The study will be a prospective, non-randomized, single center, trial to assess and quantify lung strain using 4D-CT treatment planning scans.
Measured: Pre-treatment (baseline) up to 6 months post-treatment
Secondary outcomes (3)
correlate 4D-CT based lung strain modeling with standard lung function studies including pulmonary function tests and ventilation-perfusion scans.
4D-CT based lung strain modeling comparison with standard lung function
Measured: 2 years post treatment
correlate pre- and post-treatment strain with clinical toxicity
Toxicity correlation
Measured: Pre-treatment (baseline) to 2 years post treatment
correlate post-treatment strain with radiographic changes to the lung parenchyma
Lung parenchyma correlation
Measured: 2 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
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.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Responsible party
- Principal investigator, Neal Edward Dunlap, University of Louisville
- Investigators
- Neal E Dunlap, MD, Principal investigator, James Graham Brown Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500876
- Sponsor's protocol ID
- BCC-RAD-11-02
- Status last verified
- Jun 2021
- First submitted
- 5 Dec 2011
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Using Four-Dimensional CT Imaging to Evaluate Lung Strain in Patients Treated With External Beam Radiation Therapy for Primary Lung Cancer
- ClinicalTrials.gov ID
- NCT01500876
- Acronym / sponsor ID
- BCC-RAD-11-02
- Conditions
- Lung Cancer
- Keywords
- lung cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Study start
- Jan 2012
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 29 Dec 2011 (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.
Eligible lung cancer patients: Undergo pre-treatment 4D-CT study for treatment planning
External Beam Radiation: standard fractionation (2Gy per day) or stereotactic body radiation therapy
Evaluation: Repeat 4D-CT study at 3 months and 6 months post-treatment
Primary objectives: To assess pre-treatment global and focal lung strain and correlate with changes post-treatment
Detailed description
The study will be a prospective, non-randomized, single center, trial to assess and quantify lung strain using four dimensional CT (4D-CT) treatment planning scans. Patients with newly diagnosed lung cancer will be planned using 4D-CT to assess lung and tumor motion. Standard radiation treatment plans will to delivered based on tumor stage. Patients will be reassessed both clinically and radiographically using 4D-CT imaging at 3 months and 6 months post-treatment. Following the initial imaging time points, standard surveillance will be employed with clinical assessment and imaging at 3 month intervals for the first 2 years post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Radiation: 4D-CT pre-treatment scanSingle Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >/= 18 years
- ECOG performance status 0-1
- Pathologic or clinical diagnosis of lung malignancy
- Patients must have a reproducible tidal volume sufficient for 4D-CT imaging
- Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
Key exclusion criteria (2 listed)
- Patients with severe pulmonary dysfunction with non-reproducible tidal volumes sufficient for 4D-CT imaging.
- Pregnant women or lactating women
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 |
|---|---|---|
| 4D-CT pre-treatment scanAlso: planning External Beam Radiation,, 4D-CT studyUndergo pre-treatment 4D-CT study for treatment planning External Beam Radiation: standard fractionation (2Gy per day) or stereotactic body radiation therapy Evaluation: Repeat 4D-CT study at 3 months and 6 months post-treatment | Radiation | Study Arm |
Primary outcome
validate lung strain modeling using 4D-CT in a lung cancer patient population to correlate pre-treatment strain with post-treatment changes.
Time frame: Pre-treatment (baseline) up to 6 months post-treatment
The study will be a prospective, non-randomized, single center, trial to assess and quantify lung strain using 4D-CT treatment planning scans.
3 secondary outcomes
correlate 4D-CT based lung strain modeling with standard lung function studies including pulmonary function tests and ventilation-perfusion scans.
Time frame: 2 years post treatment
correlate pre- and post-treatment strain with clinical toxicity
Time frame: Pre-treatment (baseline) to 2 years post treatment
correlate post-treatment strain with radiographic changes to the lung parenchyma
Time frame: 2 years post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
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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.
Neal E Dunlap, MD principal investigator
James Graham Brown Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4D-CT pre-treatment scan in people with Lung Cancer, run by University of Louisville 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 2 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: status not confirmed, as of the sponsor's last update on 22 Jun 2021. 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?
Results are not available in the source record.
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?
validate lung strain modeling using 4D-CT in a lung cancer patient population to correlate pre-treatment strain with post-treatment changes. (time frame: Pre-treatment (baseline) up to 6 months post-treatment). 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 22 Jun 2021.