Pulmonary LesionsPhase 3pGGONCT01429649
Study of Ablation for the Pulmonary Focal Pure Ground Glass Opacity (pGGO)
A Phase 3 study testing cryotherapy or radiofrequency ablation in people with Pulmonary Lesions, run by Dongfang Hospital Beijing University of Chinese Medicine at 1 site in China.
Trial summary
With the advent of CT screening for lung cancer, there is an increase in the detection of pulmonary lesions with focal pure ground-glass opacity (pGGO). The pure Ground-glass opacities can be caused by normal expiration, partial filling of air spaces, partial collapse of alveoli, interstitial thickening, inflammation… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Pulmonary Lesions
- What is being tested?
- cryotherapy or radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to Dec 2014
- Phase
- Phase 3
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The lesion(s) treated with ablation must be =< 2.0 cm in greatest dimension
- All patients are required to have been evaluated in a multi-disciplinary tumor conference to ensure that the lesion is suitable for Image-guided percutaneous ablation
- Platelet count ≥ 100 x 109/L
- International normalized ratio (INR) < 1.5
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- A signed study specific consent form is required
Who cannot join
- Direct evidence of regional or distant metastases,or synchronous primary or prior malignancy in the past 5 years
- Unable to lie flat or has respiratory distress at rest
- Uncontrolled coagulopathy or bleeding disorders
- Evidence of active systemic, pulmonary, or pericardial infection
- Women who are pregnant or breastfeeding
- Patients with poor pulmonary function
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dongfang Hospital
Fuzhou, Fujian, 350025
Yonggang Liang, +8659122859888 ext. 59388, war_ren@163.com
About this study
Official title: A Prospective Study of Ablation of Pulmonary Focal Pure Ground Glass Opacity
With the advent of CT screening for lung cancer, there is an increase in the detection of pulmonary lesions with focal pure ground-glass opacity (pGGO). The pure Ground-glass opacities can be caused by normal expiration, partial filling of air spaces, partial collapse of alveoli, interstitial thickening, inflammation, oedema, fibrosis, and lepidic proliferation of neoplasm. Precise details of the natural history of focal pure GGO are still largely unclear. A number of differential diagnoses are possible, including inflammatory disease, focal scar, atypical adenomatous hyperplasia (AAH), and adenocarcinoma in situ. Some of pGGOs remained stable over a considerable time. A long doubling time for pGGOs is already known. Therefore, the strategy of treatment for focal pure GGO lesions is still undecided. The major issue is whether or not the doctors should treat these patients at all or wait until the first sign of a solid lesion developes which may take many years.
The purpose of this study is to determine if the ablation therapy is safe and effective for the pulmonary pGGO.
- Conditions
- Pulmonary Lesions
- Being tested
- cryotherapy or radiofrequency ablation
- Keywords
- pure pulmonary ground glass opacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryotherapy or radiofrequency ablationProcedure or surgery
Cryoablation or Radiofrequency ablation is performed under CT image guidance.
| Study group | Role | What they receive |
|---|---|---|
| ablation | Experimental | Cryoablation or Radiofrequency ablation for the pGGO Receives: Procedure: cryotherapy or radiofrequency ablation |
| Follow up CT scann | No intervention | The patients will receive follow up with CT scan every 6-9 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changing of the lesion
To determine the efficacy rate of CT image guided ablation for pulmonary focal pGGO.
To determine the feasibility and safety of CT image guided ablation in patients with pulmonary pGGO.
Measured: 3 years
Secondary outcomes (1)
The side effect of the therapy.
Intra and post-operative complications rates. Quality-of-life assessment
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary LesionsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongfang Hospital Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Weisheng, Dongfang Hospital Beijing University of Chinese Medicine
- Investigators
- Weisheng Chen, MD, Principal investigator, Dongfang Hospital Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429649
- Sponsor's protocol ID
- kj2011001
- Acronym
- pGGO
- Status last verified
- Sep 2011
- First submitted
- 3 Sep 2011
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Ablation of Pulmonary Focal Pure Ground Glass Opacity
- ClinicalTrials.gov ID
- NCT01429649
- Acronym / sponsor ID
- pGGO / kj2011001
- Conditions
- Pulmonary Lesions
- Keywords
- pure pulmonary ground glass opacity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dongfang Hospital Beijing University of Chinese MedicineUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 7 Sep 2011 (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.
With the advent of CT screening for lung cancer, there is an increase in the detection of pulmonary lesions with focal pure ground-glass opacity (pGGO). The pure Ground-glass opacities can be caused by normal expiration, partial filling of air spaces, partial collapse of alveoli, interstitial thickening, inflammation, oedema, fibrosis, and lepidic proliferation of neoplasm. Precise details of the natural history of focal pure GGO are still largely unclear. A number of differential diagnoses are possible, including inflammatory disease, focal scar, atypical adenomatous hyperplasia (AAH), and adenocarcinoma in situ. Some of pGGOs remained stable over a considerable time. A long doubling time for pGGOs is already known. Therefore, the strategy of treatment for focal pure GGO lesions is still undecided. The major issue is whether or not the doctors should treat these patients at all or wait until the first sign of a solid lesion developes which may take many years.
The purpose of this study is to determine if the ablation therapy is safe and effective for the pulmonary pGGO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ablation | Experimental | Procedure: cryotherapy or radiofrequency ablationCryoablation or Radiofrequency ablation for the pGGO |
| Follow up CT scann | No intervention | –The patients will receive follow up with CT scan every 6-9 months. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The lesion(s) treated with ablation must be =< 2.0 cm in greatest dimension
- All patients are required to have been evaluated in a multi-disciplinary tumor conference to ensure that the lesion is suitable for Image-guided percutaneous ablation
- Platelet count ≥ 100 x 109/L
- International normalized ratio (INR) < 1.5
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
Key exclusion criteria (6 listed)
- Direct evidence of regional or distant metastases,or synchronous primary or prior malignancy in the past 5 years
- Unable to lie flat or has respiratory distress at rest
- Uncontrolled coagulopathy or bleeding disorders
- Evidence of active systemic, pulmonary, or pericardial infection
- Women who are pregnant or breastfeeding
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 |
|---|---|---|
| cryotherapy or radiofrequency ablationCryoablation or Radiofrequency ablation is performed under CT image guidance. | Procedure or surgery | ablation |
Primary outcome
The changing of the lesion
Time frame: 3 years
To determine the efficacy rate of CT image guided ablation for pulmonary focal pGGO. To determine the feasibility and safety of CT image guided ablation in patients with pulmonary pGGO.
1 secondary outcome
The side effect of the therapy.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2011.
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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.
Weisheng Chen, MD principal investigator
Dongfang Hospital Beijing University of Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cryotherapy or radiofrequency ablation in people with Pulmonary Lesions, run by Dongfang Hospital Beijing University of Chinese Medicine at 1 site in China.
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 6 inclusion and 6 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 7 Sep 2011. 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Weisheng Chen, MD (+8618960826090, weishengmd@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changing of the lesion (time frame: 3 years). 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 7 Sep 2011.