N/A
N=9
Lung Volume Reduction for Severe Emphysema by Stereotactic Ablative Radiation Therapy
Emphysema
Bottom Line
View on ClinicalTrials.gov: NCT03673176 ↗Enrolled (actual)
9
Serious AEs
44.4%
Results posted
Jul 2024
Primary outcome: Primary: Count of Patients With Grade 3 or Higher Adverse Events. — 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stereotactic Ablative Radiotherapy (SABR) (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Count of Patients With Grade 3 or Higher Adverse Events. |
3 | — |
| SECONDARY Change From Baseline Value in Forced Expiratory Volume Percent Predicted |
28.5; 5.0; 3.0; 5.5 | — |
| SECONDARY Change From Baseline Value in Forced Expiratory Volume in 1 Second (Liters) |
0.79; 0.13; 0.14; 0.02 | — |
| SECONDARY Change From Baseline in Diffusing Capacity for Carbon Dioxide (% Predicted) |
40.0; -8.0; -10.0; -3.5 | — |
| SECONDARY Change From Baseline in 6 Minute Walk Test (Meters) |
289.0; 406.0; 27.0 | — |
| SECONDARY Total Lung Capacity (% of Predicted Value) |
127.5; 119.5 | — |
| SECONDARY Residual Volume (RV) (% of Predicted Value) |
191; 188 | — |
| SECONDARY Short Form (SF)-36 Quality of Life Survey Score |
31.9; 24.9; 48.0; 51.5 | — |
| SECONDARY Modified Borg Dyspnea Scale |
— | — |
Summary
Since medical therapies offer only modest palliation and minimal hopes for improved survival to COPD patients, surgical therapies have been designed that may provide greater benefits in selected patients. Lung transplantation, for example, clearly improves survival and quality of life in patients with end stage COPD. This comes at substantial economic cost, however, as well as the at the cost of complications that may result from the complex surgery and from life-long immunosuppression. In addition, nearly all lung transplants will fail within 5 years as a result of progressive bronchiolitis obliterans, which we currently have no way to prevent or treat.
A second operation designed to treat severe COPD patients is lung volume reduction surgery (LVRS). This operation, designed for patients with predominant emphysema rather than chronic bronchitis, is among the most carefully studied operations ever developed.
We believe that by reducing the volume of emphysematous lung with the precise target localization made possible by image-guided SABR, that we will be able to duplicate the benefits of surgical lung volume reduction with far less risk. We believe that this may represent a major advance in the therapy of emphysema - a highly prevalent disease. It may provide not only palliation but also increased survival, as does surgical lung volume reduction, in carefully selected patients.
Eligibility Criteria
Inclusion Criteria
Pulmonary Function:
- Severe COPD with severe reduction in quality of life due to dyspnea
- Moderate to Severe emphysematous destruction of lung parenchyma on chest CT
- FEV1 18% predicted
- FEV1/FVC 18% predicted
- Residual Volume > 160% predicted (by plethysmography)
Arterial Blood Gas:
- paO2>40 on room air at rest
- paCO2<55
General:
- Successful completion of 16 sessions of pulmonary rehabilitation
Exclusion Criteria
- Predominate chronic bronchitis (none or mild emphysematous destruction of lung on chest CT).
- Pulmonary function tests / lung volumes that do not meet above criteria.
- Active coronary ischemia (stress test required if clinical symptoms).
- Inability to complete 16 sessions of pulmonary rehabilitation.
- Pregnancy.
- Presence of lung cancer.
Data sourced from ClinicalTrials.gov (NCT03673176). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.