Non-small Cell Lung Cancer Clinical Trial
— PEGASUSOfficial title:
Lung Perfusion PET / CT Using Gallium68-MMA for Preservation of Lung Function During Stereotactic Pulmonary Radiation Therapy
Verified date | September 2022 |
Source | University Hospital, Brest |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a prospective study evaluating the feasibility of treatment planning integrating lung perfusion PET/CT using Ga68-MAA to preserve functional lung areas during stereotactic body radiation therapy (SBRT).
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | September 30, 2023 |
Est. primary completion date | July 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age >18 years - Insured patient - Patient treated at the Brest CHRU for SBRT of a primary or secondary pulmonary lesion Exclusion Criteria: - Unable/unwilling to give informed consent - Pregnancy / breast-feeding patient - Patient under guardianship or curatorship - Patient with contraindication to the administration of macroaggregates of human albumin |
Country | Name | City | State |
---|---|---|---|
France | CHRU de Brest | Brest | Brest Cedex |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Brest |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patients with a dose reduction to the functional lung (estimated during functional planning). | Percentage of patients for whom it is possible to reduce the dose to the functional lung (estimated during the functional planning).
A reduction in the dose to the functional lung will be defined by: A decrease of at least 5% in functional lung volume included in V20Gy. or A decrease of at least 5% in total relative lung function included in the V20G. |
Baseline, one week after lung perfusion PET / CT scan using Ga68-MAA | |
Secondary | Impact of lung perfusion PET / CT scan on lung activity during SBRT (stereotactic body radiation therapy) planning | Percentage of activity included in the V20Gy with the anatomical planning and the functional planning. | Baseline, one week after lung perfusion PET / CT scan using Ga68-MAA | |
Secondary | Impact of lung perfusion PET / CT scan on lung activity during SBRT (stereotactic body radiation therapy) planning | Percentage of functional lung volume included in the V20Gy with anatomical planning and during functional planning | Baseline, one week after lung perfusion PET / CT scan using Ga68-MAA | |
Secondary | Pulmonary toxicity at 3 months | Pulmonary toxicity defined according to EORTC (European Organisation for Research and Treatment of Cancer) criteria (Common Terminology Criteria for Adverse Events 5.0, EORTC QLQ-C30 : European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - Cancer module 30) at 3 months | At 3 months after SBRT (stereotactic body radiation therapy) | |
Secondary | Pulmonary toxicity at 3 months | Pulmonary toxicity defined according to EORTC (European Organisation for Research and Treatment of Cancer) criteria (Common Terminology Criteria for Adverse Events 5.0, EORTC QLQ-LC13 :European Organisation for Research and Treatment of Cancer- Quality of Life Questionnaire - Lung Cancer module 13) at 3 months | At 3 months after SBRT( stereotactic body radiation therapy) | |
Secondary | Pulmonary toxicity at 6 months | Pulmonary toxicity defined according to EORTC (European Organisation for Research and Treatment of Cancer) criteria (Common Terminology Criteria for Adverse Events 5.0, EORTC QLQ-C30 : European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire -Cancer module 30) at 6 months | At 6 months after SBRT (stereotactic body radiation therapy) | |
Secondary | Pulmonary toxicity at 6 months | Pulmonary toxicity defined according to EORTC (European Organisation for Research and Treatment of Cancer) criteria (Common Terminology Criteria for Adverse Events 5.0, EORTC QLQ-LC13 : European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - Lung Cancer module 13) at 6 months | At 6 months after SBRT (stereotactic body radiation therapy) | |
Secondary | Pulmonary toxicity at 9 months | Pulmonary toxicity defined according to EORTC (European Organisation for Research and Treatment of Cancer) criteria (Common Terminology Criteria for Adverse Events 5.0, EORTC QLQ-C30 : European Organisation for Research and Treatment of Cancer -Quality of Life Questionnaire - Cancer module 30) at 9 months | At 9 months after SBRT (stereotactic body radiation therapy) | |
Secondary | Pulmonary toxicity at 9 months | Pulmonary toxicity defined according to EORTC (European Organisation for Research and Treatment of Cancer) criteria (Common Terminology Criteria for Adverse Events 5.0, EORTC QLQ-LC13 : European Organisation for Research and Treatment of Cancer -Quality of Life Questionnaire - Lung Cancer module 13) at 9 months | At 9 months after SBRT (stereotactic body radiation therapy) | |
Secondary | Pulmonary toxicity at 12 months | Pulmonary toxicity defined according to EORTC (European Organisation for Research and Treatment of Cancer) criteria (Common Terminology Criteria for Adverse Events 5.0, EORTC QLQ-C30 : European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - Cancer module 30) at 12 months | At 12 months after SBRT (stereotactic body radiation therapy) | |
Secondary | Pulmonary toxicity at 12 months | Pulmonary toxicity defined according to EORTC (European Organisation for Research and Treatment of Cancer) criteria (Common Terminology Criteria for Adverse Events 5.0, EORTC QLQ-LC13 : European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - Lung Cancer module 13) at 12 months | At 12 months after SBRT (stereotactic body radiation therapy) | |
Secondary | Dyspnea at Day 0 (inclusion) | Results of EuroQol (EQ-5D-5L) questionnaire | Baseline, Day 0 | |
Secondary | Dyspnea at Day 0 (inclusion) | Results of Pulmonary Function testing (PFT) : FEV1 | Baseline, Day 0 | |
Secondary | Dyspnea at Day 0 (inclusion) | Results of Pulmonary Function testing (PFT) : FEV1/FVC | Baseline, Day 0 | |
Secondary | Dyspnea at Day 0 (inclusion) | Results of 6 minutes Walk Test (6MWT) | Baseline, Day 0 | |
Secondary | Dyspnea at 3 months | Results of EuroQol (EQ-5D-5L) questionnaire | At 3 months after SBRT (stereotactic body radiation therapy) | |
Secondary | Dyspnea at 3 months | Results of Pulmonary Function testing (PFT) : FEV1 | At 3 months after SBRT (stereotactic body radiation therapy) | |
Secondary | Dyspnea at 3 months | Results of Pulmonary Function testing (PFT) : FEV1/FVC | At 3 months after SBRT (stereotactic body radiation therapy) | |
Secondary | Dyspnea at 3 months | Results of 6 minutes Walk Test (6MWT) | At 3 months after SBRT (stereotactic body radiation therapy) | |
Secondary | Dyspnea at 6 months | Results of EuroQol (EQ-5D-5L) questionnaire | At 6 months after SBRT (stereotactic body radiation therapy) | |
Secondary | Dyspnea at 6 months | Results of Pulmonary Function testing (PFT) : FEV1 | At 6 months after SBRT (stereotactic body radiation therapy) | |
Secondary | Dyspnea at 6 months | Results of Pulmonary Function testing (PFT) : FEV1/FVC | At 6 months after SBRT (stereotactic body radiation therapy) | |
Secondary | Dyspnea at 6 months | Results of 6 minutes Walk Test (6MWT) | At 6 months after SBRT (stereotactic body radiation therapy) | |
Secondary | Dyspnea at 9 months | Results of EuroQol (EQ-5D-5L) questionnaire | At 9 months after SBRT (stereotactic body radiation therapy) | |
Secondary | Dyspnea at 9 months | Results of Pulmonary Function testing (PFT) : FEV1 | At 9 months after SBRT (stereotactic body radiation therapy) | |
Secondary | Dyspnea at 9 months | Results of Pulmonary Function testing (PFT) : FEV1/FVC | At 9 months after SBRT (stereotactic body radiation therapy) | |
Secondary | Dyspnea at 9 months | Results of 6 minutes Walk Test (6MWT) | At 9 months after SBRT (stereotactic body radiation therapy) | |
Secondary | Dyspnea at 12 months | Results of EuroQol (EQ-5D-5L) questionnaire | At 12 months after SBRT (stereotactic body radiation therapy) | |
Secondary | Dyspnea at 12 months | Results of Pulmonary Function testing (PFT) : FEV1 | At 12 months after SBRT (stereotactic body radiation therapy) | |
Secondary | Dyspnea at 12 months | Results of Pulmonary Function testing (PFT) : FEV1/FVC | At 12 months after SBRT (stereotactic body radiation therapy) | |
Secondary | Dyspnea at 12 months | Results of 6 minutes Walk Test (6MWT) | At 12 months after SBRT (stereotactic body radiation therapy) |
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