CClinicalTrials.gg
Sign In
Status unknownNCT01429649pGGOUpdated Sep 7, 2011

Study of Ablation for the Pulmonary Focal Pure Ground Glass Opacity (pGGO)

A Phase 3 interventional study of cryotherapy or radiofrequency ablation in Pulmonary Lesions, sponsored by Dongfang Hospital Beijing University of Chinese Medicine. Status unknown at 1 site in China. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-09-07.

Sponsored by Dongfang Hospital Beijing University of Chinese Medicine · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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, 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.

02

Conditions studied

  • Pulmonary Lesions

Keywords

  • pure pulmonary ground glass opacity
03

In context

Lead sponsor

Dongfang Hospital Beijing University of Chinese Medicine is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    ablation

    Cryoablation or Radiofrequency ablation for the pGGO

    Procedure: cryotherapy or radiofrequency ablation

  • No intervention
    Follow up CT scann

    The patients will receive follow up with CT scan every 6-9 months.

Interventions

  • Procedurecryotherapy or radiofrequency ablation

    Cryoablation or Radiofrequency ablation is performed under CT image guidance.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 years

Secondary outcomes

  1. The side effect of the therapy.

    Intra and post-operative complications rates. Quality-of-life assessment

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • Dongfang Hospital
    Fuzhou, Fujian 350025, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01429649
Lead sponsor
Dongfang Hospital Beijing University of Chinese Medicine
Responsible party
Chen Weisheng (The vice chief of the Thoracic Division, Dongfang Hospital Beijing University of Chinese Medicine) — Principal investigator
First posted
Sep 7, 2011
Start date
Sep 2011
Primary completion
Oct 2014 (estimated)
Completion
Dec 2014 (estimated)
Last update
Sep 7, 2011

Study contacts

Weisheng Chen, MD
Contact
weishengmd@hotmail.com
+8618960826090
Weisheng Chen, MD
principal investigator · Dongfang Hospital Beijing University of Chinese Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Dongfang Hospital Beijing University of Chinese Medicine

Start the discussion