Lung CancerPhase 2NCT00610844
Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors
A Phase 2 study testing pulmonary radiofrequency ablation in people with Lung Cancer and Lung Metastasis, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The purpose of the study is to evaluate the effectiveness of radiofrequency ablation by pathological correlation and to characterize the tissue response after treatment of primary and secondary pulmonary tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Lung Metastasis
- What is being tested?
- pulmonary radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2004to May 2006
- Phase
- Phase 2
- 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
- Signed informed consent for radiofrequency ablation and surgery
- Maximum of 3 lung tumors
- Maximum tumor size 5 cm
- Must be able to receive standard surgery
Who cannot join
- Pathological coagulation tests
- Pregnant or breast feeding
- Maximum tumor size more than 5 cm
- Bilateral secondary lung cancer with more than 3 tumors
- Inoperable patient
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Diagnostic Radiology
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Evaluation of Effectiveness of Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors
The purpose of the study is to evaluate the effectiveness of radiofrequency ablation by pathological correlation and to characterize the tissue response after treatment of primary and secondary pulmonary tumors.
Read the detailed description
Thermal ablation therapy is an increasingly performed technique in the local tumor treatment. Among these techniques, image-guided radiofrequency (RF) ablation attained widespread consideration in the therapy of liver tumors and osteoid osteoma. Promising results of hepatic RF ablation raised expectations to utilize the advantages of image-guided ablation therapy for the treatment of pulmonary malignancies. The purpose of the study is to evaluate the effectiveness of radiofrequency ablation by pathological correlation and to characterize the tissue response after treatment of primary and secondary pulmonary tumors. Computed tomography-guided RF ablation is performed in local or general anesthesia, followed by surgical resection three days later. An analysis of complete RF ablation and a characterization of tissue response is performed by hematoxylin and eosin staining, immunostaining, and electron microscopy. Adverse effects and complications are recorded.
- Conditions
- Lung Cancer, Lung Metastasis
- Being tested
- pulmonary radiofrequency ablation
- Keywords
- lung cancer, lung metastasis, radiofrequency ablation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary radiofrequency ablationProcedure or surgery
CT-guided pulmonary radiofrequency ablation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | pulmonary radiofrequency ablation Receives: Procedure: pulmonary radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of incomplete treated tumors
Measured: 3 days
Secondary outcomes (1)
pathologic tissue changes, rate of major and minor complications
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startApr 2004
- Primary completionMay 2006
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 Hospital TuebingenThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Philippe L Pereira, MD, Principal investigator, Department of Diagnostic Radiology, University of TübingenHermann Aebert, MD, Principal investigator, Department of thoracic surgery, University of Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610844
- Sponsor's protocol ID
- LungRFA_V1
- Status last verified
- Nov 2007
- First submitted
- 28 Jan 2008
- Last updated
- 20 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness of Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors
- ClinicalTrials.gov ID
- NCT00610844
- Acronym / sponsor ID
- LungRFA_V1
- Conditions
- Lung Cancer, Lung Metastasis
- Keywords
- lung cancer, lung metastasis, radiofrequency ablation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- May 2006 (actual)
- First posted
- 8 Feb 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 purpose of the study is to evaluate the effectiveness of radiofrequency ablation by pathological correlation and to characterize the tissue response after treatment of primary and secondary pulmonary tumors.
Detailed description
Thermal ablation therapy is an increasingly performed technique in the local tumor treatment. Among these techniques, image-guided radiofrequency (RF) ablation attained widespread consideration in the therapy of liver tumors and osteoid osteoma. Promising results of hepatic RF ablation raised expectations to utilize the advantages of image-guided ablation therapy for the treatment of pulmonary malignancies. The purpose of the study is to evaluate the effectiveness of radiofrequency ablation by pathological correlation and to characterize the tissue response after treatment of primary and secondary pulmonary tumors. Computed tomography-guided RF ablation is performed in local or general anesthesia, followed by surgical resection three days later. An analysis of complete RF ablation and a characterization of tissue response is performed by hematoxylin and eosin staining, immunostaining, and electron microscopy. Adverse effects and complications are recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: pulmonary radiofrequency ablationpulmonary radiofrequency ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent for radiofrequency ablation and surgery
- Maximum of 3 lung tumors
- Maximum tumor size 5 cm
- Must be able to receive standard surgery
Key exclusion criteria (5 listed)
- Pathological coagulation tests
- Pregnant or breast feeding
- Maximum tumor size more than 5 cm
- Bilateral secondary lung cancer with more than 3 tumors
- Inoperable patient
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 |
|---|---|---|
| pulmonary radiofrequency ablationCT-guided pulmonary radiofrequency ablation | Procedure or surgery | 1 |
Primary outcome
rate of incomplete treated tumors
Time frame: 3 days
1 secondary outcome
pathologic tissue changes, rate of major and minor complications
Time frame: 6 months
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 20 Feb 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.
Philippe L Pereira, MD principal investigator
Department of Diagnostic Radiology, University of Tübingen
Hermann Aebert, MD principal investigator
Department of thoracic surgery, University of Tübingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pulmonary radiofrequency ablation in people with Lung Cancer and Lung Metastasis, run by University Hospital Tuebingen at 1 site in Germany.
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 5 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 20 Feb 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 Germany. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
rate of incomplete treated tumors (time frame: 3 days). 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 20 Feb 2008.