Lung CancerNCT01888510
CT in Diagnosing Patients With Lung Cancer
A study testing computed tomography, 4-dimensional computed tomography and cone-beam computed tomography in people with Lung Cancer, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This clinical trial studies computed tomography (CT) in diagnosing patients with lung cancer. Diagnostic procedures, such as CT, may help find and diagnose 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?
- computed tomography, 4-dimensional computed tomography and cone-beam computed tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jun 2016
- 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
- Measurable disease on CT scan
- Patients with lung cancer visible on CT who are scheduled to receive external beam radiation treatment will be eligible for this study
- Patients must be able to perform ABC procedures
Who cannot join
- Patients requiring continuous supplemental oxygen due to the requirement of spirometry during all imaging studies
- No vulnerable populations will be enrolled (prisoners, children, pregnant females or institutionalized individuals)
- Women of childbearing potential will undergo a pregnancy test
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
About this study
Official title: Comparison of Conventional Free Breathing CT, 4D CT, and Integrated Active Breath Hold CT Image Acquisition for Lung Cancer
This clinical trial studies computed tomography (CT) in diagnosing patients with lung cancer. Diagnostic procedures, such as CT, may help find and diagnose lung cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- Conduct a prospective clinical imaging study to quantify the amount of inter- and intra-physician contouring variability on four dimensional (4D) CT, active breathing control (ABC) CT, free breathing CT, and free breathing and ABC cone beam (CB)CT.
II. Quantify the magnitude and distribution of target and organ at risk volume variations between the different imaging modalities.
III. Determine dosimetric changes related to contouring variations for tumor and normal tissue.
OUTLINE:
Patients undergo conventional free breathing CT, 4D CT, ABC CT, ABC CBCT, and free breathing CBCT before undergoing radiation therapy.
- Conditions
- Lung Cancer
- Being tested
- computed tomography, 4-dimensional computed tomography, cone-beam computed tomography
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed tomographyProcedure or surgery
Also called tomography, computed
Undergo conventional free breathing CT
4-dimensional computed tomographyProcedure or surgery
Also called 4D-CT
Undergo 4D CT
computed tomographyProcedure or surgery
Also called tomography, computed
Undergo ABC CT
cone-beam computed tomographyProcedure or surgery
Undergo ABC CBCT
cone-beam computed tomographyProcedure or surgery
Undergo free breathing CBCT
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (imaging studies) | Experimental | Patients undergo conventional free breathing CT, 4D CT, ABC CT, ABC CBCT, and free breathing CBCT before undergoing radiation therapy. Receives: Procedure: computed tomography; Procedure: 4-dimensional computed tomography; Procedure: cone-beam computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of inter- and intra-physician contouring variability on 4D CT, ABC CT, free breathing CT, and free breathing and ABC CBCT
A two sided t-test with 5% level of significance will be used.
Measured: up to 1 week
Secondary outcomes (2)
Magnitude and distribution of target and organ at risk volume variations between the different imaging modalities
A two sided t-test with 5% level of significance will be used.
Measured: up to 1 week
Dosimetric changes related to contouring variations for tumor and normal tissue
A two sided t-test with 5% level of significance will be used.
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2016
- Study completionJun 2016
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Weiss, M.D., Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888510
- Sponsor's protocol ID
- MCC-15032
- Other IDs
- NCI-2013-01163
- Status last verified
- Jul 2016
- First submitted
- 25 Jun 2013
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional Free Breathing CT, 4D CT, and Integrated Active Breath Hold CT Image Acquisition for Lung Cancer
- ClinicalTrials.gov ID
- NCT01888510
- Acronym / sponsor ID
- MCC-15032
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 Jun 2013 (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 computed tomography (CT) in diagnosing patients with lung cancer. Diagnostic procedures, such as CT, may help find and diagnose lung cancer.
Detailed description
PRIMARY OBJECTIVES:
- Conduct a prospective clinical imaging study to quantify the amount of inter- and intra-physician contouring variability on four dimensional (4D) CT, active breathing control (ABC) CT, free breathing CT, and free breathing and ABC cone beam (CB)CT.
II. Quantify the magnitude and distribution of target and organ at risk volume variations between the different imaging modalities.
III. Determine dosimetric changes related to contouring variations for tumor and normal tissue.
OUTLINE:
Patients undergo conventional free breathing CT, 4D CT, ABC CT, ABC CBCT, and free breathing CBCT before undergoing radiation therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (imaging studies) | Experimental | Procedure: computed tomography, Procedure: 4-dimensional computed tomography, Procedure: cone-beam computed tomographyPatients undergo conventional free breathing CT, 4D CT, ABC CT, ABC CBCT, and free breathing CBCT before undergoing radiation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Measurable disease on CT scan
- Patients with lung cancer visible on CT who are scheduled to receive external beam radiation treatment will be eligible for this study
- Patients must be able to perform ABC procedures
Key exclusion criteria (3 listed)
- Patients requiring continuous supplemental oxygen due to the requirement of spirometry during all imaging studies
- No vulnerable populations will be enrolled (prisoners, children, pregnant females or institutionalized individuals)
- Women of childbearing potential will undergo a pregnancy test
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 |
|---|---|---|
| computed tomographyAlso: tomography, computedUndergo conventional free breathing CT | Procedure or surgery | Diagnostic (imaging studies) |
| 4-dimensional computed tomographyAlso: 4D-CTUndergo 4D CT | Procedure or surgery | Diagnostic (imaging studies) |
| computed tomographyAlso: tomography, computedUndergo ABC CT | Procedure or surgery | Diagnostic (imaging studies) |
| cone-beam computed tomographyUndergo ABC CBCT | Procedure or surgery | Diagnostic (imaging studies) |
| cone-beam computed tomographyUndergo free breathing CBCT | Procedure or surgery | Diagnostic (imaging studies) |
Primary outcome
Amount of inter- and intra-physician contouring variability on 4D CT, ABC CT, free breathing CT, and free breathing and ABC CBCT
Time frame: up to 1 week
A two sided t-test with 5% level of significance will be used.
2 secondary outcomes
Magnitude and distribution of target and organ at risk volume variations between the different imaging modalities
Time frame: up to 1 week
Dosimetric changes related to contouring variations for tumor and normal tissue
Time frame: up to 1 week
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 7 Jul 2016.
Related trials for Lung Cancer
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.
Elizabeth Weiss, M.D. principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computed tomography, 4-dimensional computed tomography and cone-beam computed tomography in people with Lung Cancer, run by Virginia Commonwealth University 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 3 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 7 Jul 2016. 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?
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?
Amount of inter- and intra-physician contouring variability on 4D CT, ABC CT, free breathing CT, and free breathing and ABC CBCT (time frame: up to 1 week). 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 7 Jul 2016.