Carcinoma, Non Small Cell LungNCT00184964
Validation of Coregistered CT-PET Imaging in Determining Tumor Volume and Atelectasis in Patients With Operable Non-Small-Cell Lung Cancer and Tumor Associated Atelectasis
A study testing CT-scan, PET-scan in people with Carcinoma, Non Small Cell Lung, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
CT-PET image fusion has the potential to differentiate 'tumor' from 'atelectasis' much better than the CT-scan in patients with non-small cell lung cancer who also have atelectasis. This however has never been validated on a histological level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non Small Cell Lung
- What is being tested?
- CT-scan, PET-scan
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2004to not given
- 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
- -Patients with non small cell lung cancer and atelectasis, who are eligible for surgery.
Who cannot join
- age < 18 years
- pregnancy
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500HB
Dominic A Schinagl, MD, +31243614515, d.schinagl@rther.umcn.nl
Dominic A Schinagl, MD
About this study
Official title: The Validation of Coregistered CT-PET Imaging in Determining Tumor Volume and Atelectasis in Patients With Operable Non-Small-Cell Lung Cancer and Tumor Associated Atelectasis With Histological Examination of the Resected Specimen
CT-PET image fusion has the potential to differentiate 'tumor' from 'atelectasis' much better than the CT-scan in patients with non-small cell lung cancer who also have atelectasis.
This however has never been validated on a histological level. In this study patients with non small cell lung cancer and atelectasis who are eligible for surgery undergo a CT-scan and a PET-scan prior to surgery.
The resection specimen will be compared to the preoperative imaging.
- Conditions
- Carcinoma, Non Small Cell Lung
- Being tested
- CT-scan, PET-scan
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-scan, PET-scanProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological validation of CT-PET image fusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non Small Cell LungStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Jan Bussink, MD, PhD, Study director, Radiation oncologist, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184964
- Sponsor's protocol ID
- 2004/032
- Status last verified
- Jun 2008
- First submitted
- 12 Sep 2005
- Last updated
- 4 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validation of Coregistered CT-PET Imaging in Determining Tumor Volume and Atelectasis in Patients With Operable Non-Small-Cell Lung Cancer and Tumor Associated Atelectasis With Histological Examination of the Resected Specimen
- ClinicalTrials.gov ID
- NCT00184964
- Acronym / sponsor ID
- 2004/032
- Conditions
- Carcinoma, Non Small Cell Lung
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jun 2004
- First posted
- 16 Sep 2005 (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.
CT-PET image fusion has the potential to differentiate 'tumor' from 'atelectasis' much better than the CT-scan in patients with non-small cell lung cancer who also have atelectasis.
This however has never been validated on a histological level. In this study patients with non small cell lung cancer and atelectasis who are eligible for surgery undergo a CT-scan and a PET-scan prior to surgery.
The resection specimen will be compared to the preoperative imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Patients with non small cell lung cancer and atelectasis, who are eligible for surgery.
Key exclusion criteria (2 listed)
- age < 18 years
- pregnancy
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 |
|---|---|---|
| CT-scan, PET-scan | Procedure or surgery | – |
Primary outcome
Histological validation of CT-PET image fusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2008.
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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.
Jan Bussink, MD, PhD study director
Radiation oncologist, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-scan, PET-scan in people with Carcinoma, Non Small Cell Lung, run by Radboud University Medical Center at 1 site in Netherlands.
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 1 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 4 Jun 2008. 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 Netherlands. 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?
Contact Dominic A Schinagl, MD (+31243614515, d.schinagl@rther.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological validation of CT-PET image fusion.. 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 Jun 2008.