Lung CancerEarly Phase 1NCT01034514
4D-CT-based Ventilation Imaging for Adaptive Functional Guidance in Radiotherapy
A Early Phase 1 study testing Real-time Position Management system, Discovery ST multislice PET/CT scanner and Infinia Hawkeye SPECT/CT gamma camera in people with Lung Cancer, run by Billy W. Loo Jr. at 1 site in United States.
Trial summary
To develop and investigate a novel radiotherapy technique for preserving lung function based on a map of lung function. 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?
- Real-time Position Management system, Discovery ST multislice PET/CT scanner and Infinia Hawkeye SPECT/CT gamma camera
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to 24 Jun 2014
- Phase
- Early Phase 1
- 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
- Eligible disease(s)/stage(s) AJCC Stage I, II, III or IV lung cancer of any histology to be treated using radiotherapy will be eligible for this study. Note that we will carefully consider the inclusion of cases with turbulent flow or greater flow velocities (Cabahug et al., 1996; Crawford et al., 1990) and COPD cases (Magnant et al., 2006) due to the impaction of aerosol particles in central airways.
- Allowable type and amount of prior therapy. Any types and amounts of prior therapy will be allowed for this study.
- Age restriction and/or gender/ethnic restrictions
- Patients must be greater than or equal to 18 years of age.
- There are no gender or ethnic restrictions.
- Life expectancy restrictions - None.
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- ECOG or Karnofsky Performance Status
- Not employed. Note that patients will need to be sufficiently healthy to undergo audiovisual (AV) biofeedback to generate high quality 4D-CT images.
- Requirements for organ and marrow function None.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Children (less than 18 years of age), pregnant women, Stanford employees or students, or prisoners will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
To develop and investigate a novel radiotherapy technique for preserving lung function based on a map of lung function.
- Conditions
- Lung Cancer
- Being tested
- Real-time Position Management system, Discovery ST multislice PET/CT scanner, Infinia Hawkeye SPECT/CT gamma camera, Pinnacle3 treatment planning system, SKYLight nuclear camera
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time Position Management systemDevice
Also called RPM System
Standard of Care
Discovery ST multislice PET/CT scannerDevice
Also called Positron Emission Tomography
Standard of Care
Infinia Hawkeye SPECT/CT gamma cameraDevice
Also called Single-photon emission computed tomography
Standard of Care
Pinnacle3 treatment planning systemDevice
Also called Radiation Treatment Planning
Standard of Care
SKYLight nuclear cameraDevice
Also called Philips Medical Systems
Standard of Care
DTPADrug
Also called DRAXIS Specialty Pharmaceuticals Inc.
1 mCi; inhalation
TECHNETIUM TC 99M MAADrug
Also called DRAXIS Specialty Pharmaceuticals Inc.
3 mCi; iv
| Study group | Role | What they receive |
|---|---|---|
| 4DCT arm | Experimental | Patients breathe in 99mTc-DTPA and then undergo ventilation scans using a SPECT scanner over 2 hours. Patients also receive 99mTc-MAA IV and then undergo perfusion scans using a SPECT scanner over 2 hours. Patients may also undergo a pre- and post-treatment Xe-CT ventilation scan over 15 minutes and a pre-treatment 4D-CT scan over 5-10 minutes. Receives: Device: Real-time Position Management system; Device: Discovery ST multislice PET/CT scanner; Device: Infinia Hawkeye SPECT/CT gamma camera; Device: Pinnacle3 treatment planning system; Device: SKYLight nuclear camera; Drug: DTPA; Drug: TECHNETIUM TC 99M MAA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall correlation between the 4D-CT and the SPECT ventilation images.
Measured: 24 months
Secondary outcomes (1)
The difference between the local ventilation at simulation and during the treatment. Dose-volume or functional dose-volume metrics. The regression coefficient between the regional ventilation and time. The mean dose to the high-functional lung region.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startDec 2009
- Primary completion24 Jun 2014
- Study completion24 Jun 2014
Why it stopped: business decision
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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Billy W. Loo Jr.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Billy W. Loo Jr., Stanford University
- Investigators
- Billy Loo, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034514
- Sponsor's protocol ID
- LUN0034
- Other IDs
- SU-04232009-2382
- Status last verified
- May 2017
- First submitted
- 16 Dec 2009
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4D-CT-based Ventilation Imaging for Adaptive Functional Guidance in Radiotherapy
- ClinicalTrials.gov ID
- NCT01034514
- Acronym / sponsor ID
- LUN0034
- Conditions
- Lung Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: business decision
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Billy W. Loo Jr.University, hospital or other
- Study start
- Dec 2009 (actual)
- Primary completion
- 24 Jun 2014 (actual)
- Study completion
- 24 Jun 2014 (actual)
- First posted
- 17 Dec 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.
To develop and investigate a novel radiotherapy technique for preserving lung function based on a map of lung function.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4DCT arm | Experimental | Device: Real-time Position Management system, Device: Discovery ST multislice PET/CT scanner, Device: Infinia Hawkeye SPECT/CT gamma camera, Device: Pinnacle3 treatment planning system, Device: SKYLight nuclear camera, Drug: DTPA, Drug: TECHNETIUM TC 99M MAAPatients breathe in 99mTc-DTPA and then undergo ventilation scans using a SPECT scanner over 2 hours. Patients also receive 99mTc-MAA IV and then undergo perfusion scans using a SPECT scanner over 2 hours. Patients may also undergo a pre- and post-treatment Xe-CT ventilation scan over 15 minutes and a pre-treatment 4D-CT scan over 5-10 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Eligible disease(s)/stage(s) AJCC Stage I, II, III or IV lung cancer of any histology to be treated using radiotherapy will be eligible for this study. Note that we will carefully consider the inclusion of cases with turbulent flow or greater flow velocities (Cabahug et al., 1996; Crawford et al., 1990) and COPD cases (Magnant et al., 2006) due to the impaction of aerosol particles in central airways.
- Allowable type and amount of prior therapy. Any types and amounts of prior therapy will be allowed for this study.
- Age restriction and/or gender/ethnic restrictions
- Patients must be greater than or equal to 18 years of age.
- There are no gender or ethnic restrictions.
Key exclusion criteria (1 listed)
- Children (less than 18 years of age), pregnant women, Stanford 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 |
|---|---|---|
| Real-time Position Management systemAlso: RPM SystemStandard of Care | Device | 4DCT arm |
| Discovery ST multislice PET/CT scannerAlso: Positron Emission TomographyStandard of Care | Device | 4DCT arm |
| Infinia Hawkeye SPECT/CT gamma cameraAlso: Single-photon emission computed tomographyStandard of Care | Device | 4DCT arm |
| Pinnacle3 treatment planning systemAlso: Radiation Treatment PlanningStandard of Care | Device | 4DCT arm |
| SKYLight nuclear cameraAlso: Philips Medical SystemsStandard of Care | Device | 4DCT arm |
| DTPAAlso: DRAXIS Specialty Pharmaceuticals Inc.1 mCi; inhalation | Drug | 4DCT arm |
| TECHNETIUM TC 99M MAAAlso: DRAXIS Specialty Pharmaceuticals Inc.3 mCi; iv | Drug | 4DCT arm |
Primary outcome
The overall correlation between the 4D-CT and the SPECT ventilation images.
Time frame: 24 months
1 secondary outcome
The difference between the local ventilation at simulation and during the treatment. Dose-volume or functional dose-volume metrics. The regression coefficient between the regional ventilation and time. The mean dose to the high-functional lung region.
Time frame: 24 months
Results and safety
The study was stopped early (reason given: business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
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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.
Billy Loo principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Real-time Position Management system, Discovery ST multislice PET/CT scanner and Infinia Hawkeye SPECT/CT gamma camera in people with Lung Cancer, run by Billy W. Loo Jr. 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 10 inclusion and 1 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: stopped early, as of the sponsor's last update on 8 May 2017. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: business decision). 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?
The overall correlation between the 4D-CT and the SPECT ventilation images. (time frame: 24 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 8 May 2017.