Lung CancerNCT00910546
Image Guided and Breathing Adapted Radiotherapy of Early Stage Lung Cancer
A study testing visicoil gold marker 0.7 x 20 mm in people with Lung Cancer, run by Gitte Fredberg Persson at 1 site in Denmark.
Trial summary
The purpose of this study is to quantify the variation in tumour middle position during a course of stereotactic body radiotherapy (SBRT), and thereby be able to design radiotherapy margins that takes into account the full motion span throughout an entire course of SBRT. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- visicoil gold marker 0.7 x 20 mm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2009to Apr 2011
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- tumor > 6 cm
- no more than 2 tumours
- histological proven non small celled lung cancer
- signed Informed Consent
Who cannot join
- Serious bleeding disorder
- Performance status 3-4
- Tumour close to large vessels (judged by interventional radiologist)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Radiation Oncology, Rigshospitalet
Copenhagen, 2100
About this study
The purpose of this study is to quantify the variation in tumour middle position during a course of stereotactic body radiotherapy (SBRT), and thereby be able to design radiotherapy margins that takes into account the full motion span throughout an entire course of SBRT.
Read the detailed description
Lung tumours move with respiration. This must be considered when designing margins for radiotherapy. This movement can be quantified by fluoroscopy or 4DCT. It is possible to identify a tumour middle position for planning. This middle position will vary from day to day and the extent of this variation is not fully known. The aim of this study is to quantify the variation in tumour middle position during a course of stereotactic body radiotherapy (SBRT), and thereby be able to design margins for patients that take into account the full motion span throughout an entire course of SBRT Patients: 15 consecutive patients with inoperable low stage lung cancer or solitary metastases to the lung (1-2) referred for SBRT - 45 Gy/3 fractions.
Methods: A gold coil will be implanted into the lung tumour one week before the planning. At planning and all treatment days supplementary 4DCT of thorax and two orthogonal fluoroscopy sessions will be performed. Tumour motion in the superior-inferior, medio-lateral and cranio-caudal direction will be measured and variation in amplitude and baseline for the tumour motion will be reported.
Perspective: By examining the variation in tumour movement it will be possible design margins for SBRT, accounting for the full tumour motion span and minimizing the risk of geographical miss and thereby optimizing the chance for local tumour control.
- Conditions
- Lung Cancer
- Being tested
- visicoil gold marker 0.7 x 20 mm
- Keywords
- Lung Cancer, Stereotactic radiotherapy, Image guidance, breathing adaption, tumor motion, implanted marker
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visicoil gold marker 0.7 x 20 mmDevice
Also called Gold Ancor
CT - guided implantation into lung tumors
| Study group | Role | What they receive |
|---|---|---|
| Implantation of gold marker | Experimental | CT guided implantation of gold marker into early stage lung tumors. Extra 4DCT scans and fluoroscopies during planning and the 3 fraction radiotherapy course. Receives: Device: visicoil gold marker 0.7 x 20 mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
motion of lung tumours
measured on 4DCT
Measured: 3 weeks
Secondary outcomes (1)
toxicity of implanting gold coils into lung tumours
complication rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startFeb 2009
- Primary completionApr 2011
- Study completionApr 2011
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gitte Fredberg Persson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gitte Fredberg Persson, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Gitte F Persson, MD, Principal investigator, Copenhagen University Hospital, RigshospitaletDitte E Nygaard, MSc, Study chair, Copenhagen University Hospital, RigshospitaletStine S Korreman, MSc PhD, Study chair, Copenhagen University Hospital, RigshospitaletLena Specht, MD DMSc, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910546
- Sponsor's protocol ID
- HPCRT002
- Other IDs
- H-B-2007-016
- Status last verified
- Feb 2021
- First submitted
- 28 May 2009
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Guided and Breathing Adapted Radiotherapy of Early Stage Lung Cancer
- ClinicalTrials.gov ID
- NCT00910546
- Acronym / sponsor ID
- HPCRT002
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Stereotactic radiotherapy, Image guidance, breathing adaption, tumor motion, implanted marker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Gitte Fredberg PerssonUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 1 Jun 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.
The purpose of this study is to quantify the variation in tumour middle position during a course of stereotactic body radiotherapy (SBRT), and thereby be able to design radiotherapy margins that takes into account the full motion span throughout an entire course of SBRT.
Detailed description
Lung tumours move with respiration. This must be considered when designing margins for radiotherapy. This movement can be quantified by fluoroscopy or 4DCT. It is possible to identify a tumour middle position for planning. This middle position will vary from day to day and the extent of this variation is not fully known. The aim of this study is to quantify the variation in tumour middle position during a course of stereotactic body radiotherapy (SBRT), and thereby be able to design margins for patients that take into account the full motion span throughout an entire course of SBRT Patients: 15 consecutive patients with inoperable low stage lung cancer or solitary metastases to the lung (1-2) referred for SBRT - 45 Gy/3 fractions.
Methods: A gold coil will be implanted into the lung tumour one week before the planning. At planning and all treatment days supplementary 4DCT of thorax and two orthogonal fluoroscopy sessions will be performed. Tumour motion in the superior-inferior, medio-lateral and cranio-caudal direction will be measured and variation in amplitude and baseline for the tumour motion will be reported.
Perspective: By examining the variation in tumour movement it will be possible design margins for SBRT, accounting for the full tumour motion span and minimizing the risk of geographical miss and thereby optimizing the chance for local tumour control.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantation of gold marker | Experimental | Device: visicoil gold marker 0.7 x 20 mmCT guided implantation of gold marker into early stage lung tumors. Extra 4DCT scans and fluoroscopies during planning and the 3 fraction radiotherapy course. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- tumor > 6 cm
- no more than 2 tumours
- histological proven non small celled lung cancer
- signed Informed Consent
Key exclusion criteria (3 listed)
- Serious bleeding disorder
- Performance status 3-4
- Tumour close to large vessels (judged by interventional radiologist)
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 |
|---|---|---|
| visicoil gold marker 0.7 x 20 mmAlso: Gold AncorCT - guided implantation into lung tumors | Device | Implantation of gold marker |
Primary outcome
motion of lung tumours
Time frame: 3 weeks
measured on 4DCT
1 secondary outcome
toxicity of implanting gold coils into lung tumours
Time frame: 1 year
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 26 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Gitte F Persson, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
Ditte E Nygaard, MSc study chair
Copenhagen University Hospital, Rigshospitalet
Stine S Korreman, MSc PhD study chair
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing visicoil gold marker 0.7 x 20 mm in people with Lung Cancer, run by Gitte Fredberg Persson at 1 site in Denmark.
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 4 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 26 Feb 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 Denmark. 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?
motion of lung tumours (time frame: 3 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 26 Feb 2021.