Lung CancerNCT00585819
Validation of a Novel Thoracic Neoplasm Radiotherapy Image Guidance Technique: A Pilot Study
A study testing reproduce breathing cycle utilizing spirometry and Freebreathing in Body fix mold in people with Lung Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The overall, broad objective of this study is to pilot the BSD technique. The specific purpose of this particular study is to generate pilot data to validate several crucial steps of the BSD technique, in particular steps 1, 2, and 4. 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?
- reproduce breathing cycle utilizing spirometry and Freebreathing in Body fix mold
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Dec 2012
- 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
- Any thoracic neoplasm scheduled to undergo radiation therapy
- 18 years or older
- Must be treated with radiation as part of standard of care
- Able to tolerate the mouthpiece for spirometry and video glasses
- Ability to provide written informed consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
The overall, broad objective of this study is to pilot the BSD technique. The specific purpose of this particular study is to generate pilot data to validate several crucial steps of the BSD technique, in particular steps 1, 2, and 4. Radiation treatments will proceed per standard of care, and will not be modified in any way during this protocol. This study is a non-treatment protocol.
- Conditions
- Lung Cancer
- Being tested
- reproduce breathing cycle utilizing spirometry, Freebreathing in Body fix mold
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reproduce breathing cycle utilizing spirometryProcedure or surgery
reproduce breathing cycle utilizing spirometry
Freebreathing in Body fix moldProcedure or surgery
Freebreathing in Body fix mold
| Study group | Role | What they receive |
|---|---|---|
| 2. Free breathing | Experimental | Freebreathing in Body fix mold Receives: Procedure: Freebreathing in Body fix mold |
| 1. breathing cycle | Experimental | reproducing breathing cycles Receives: Procedure: reproduce breathing cycle utilizing spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility of the guided breathing cycle
Measured: 6 weeks
Secondary outcomes (1)
Stability of motion envelope derived from initial 4D imaging compared to CT's obtained throughout the course of therapy
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startMay 2007
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Why it stopped: lack of interest
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 University of Wisconsin, MadisonThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Minesh Mehta, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585819
- Sponsor's protocol ID
- HSC-2007-0109
- Status last verified
- Dec 2011
- First submitted
- 21 Dec 2007
- Last updated
- 4 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Novel Thoracic Neoplasm Radiotherapy Image Guidance Technique: A Pilot Study
- ClinicalTrials.gov ID
- NCT00585819
- Acronym / sponsor ID
- HSC-2007-0109
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of interest
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 3 Jan 2008 (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.
The overall, broad objective of this study is to pilot the BSD technique. The specific purpose of this particular study is to generate pilot data to validate several crucial steps of the BSD technique, in particular steps 1, 2, and 4. Radiation treatments will proceed per standard of care, and will not be modified in any way during this protocol. This study is a non-treatment protocol.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2. Free breathing | Experimental | Procedure: Freebreathing in Body fix moldFreebreathing in Body fix mold |
| 1. breathing cycle | Experimental | Procedure: reproduce breathing cycle utilizing spirometryreproducing breathing cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Any thoracic neoplasm scheduled to undergo radiation therapy
- 18 years or older
- Must be treated with radiation as part of standard of care
- Able to tolerate the mouthpiece for spirometry and video glasses
- Ability to provide written informed consent
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| reproduce breathing cycle utilizing spirometryreproduce breathing cycle utilizing spirometry | Procedure or surgery | 1. breathing cycle |
| Freebreathing in Body fix moldFreebreathing in Body fix mold | Procedure or surgery | 2. Free breathing |
Primary outcome
Reproducibility of the guided breathing cycle
Time frame: 6 weeks
1 secondary outcome
Stability of motion envelope derived from initial 4D imaging compared to CT's obtained throughout the course of therapy
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2012.
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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.
Minesh Mehta principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reproduce breathing cycle utilizing spirometry and Freebreathing in Body fix mold in people with Lung Cancer, run by University of Wisconsin, Madison 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 5 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: withdrawn, as of the sponsor's last update on 4 Jan 2012. 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 was withdrawn before enrolling participants, so there are no results.
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?
Reproducibility of the guided breathing cycle (time frame: 6 weeks). 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 4 Jan 2012.