Lung Perfusion PET / CT Using Ga68-MAA for Preservation of Lung Function During Stereotactic Pulmonary Radiation Therapy

Study Overview
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Brief Summary
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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).

Detailed Description
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Lung perfusion PET / CT is a new imaging modality based on the use of the same cold molecules as those used for a conventional perfusion lung scan. Similartly, perfusion images are obtained after intravenous administration of human albumin macroaggregates, which are embolized in pulmonary capillaries according to pulmonary blood flow. However, these cold molecules are radiolabeled, not with Technetium99m, but with Gallium68, a ß + isotope, allowing image acquisition with PET technology. The same physiological processes are therefore observed with conventional scintigraphy PET imaging, but PET is an intrinsically superior technique for image acquisition, with greater sensitivity, better spatial and temporal resolutions and the possibility to perform respiratory-gated acquisition, allowing a better definition of the pulmonary functional volumes. The aim is to evaluate the feasability of functional lung avoidance planification using lung perfusion PET/CT imaging during SBRT. Patients will benefit from a pre-treatment functional assessment including PET/CT imaging. The treatment planning will be carried out in 2 stages: First, an anatomical planning will be carried out, blinded to the PET results. Then, a functional planning, respecting the standard constraints applied during anatomical planning, but also incorporating a new functional lung volume constraint defined by PET/CT images, will be carried out. A follow-up will be carried out for 12 months, including repeated perfusion PET/CT imaging at 3 and 12 months.

Official Title
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Lung Perfusion PET / CT Using Gallium68-MMA for Preservation of Lung Function During Stereotactic Pulmonary Radiation Therapy

Conditions
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SBRT, Non-small Cell Lung Cancer, Lung Metastasis

Intervention / Treatment
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* Drug: Pre-therapeutic imaging test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention : Lung perfusion PET/CT using Ga68-MAA and SBRT planification<br>All patients included for treatment with stereotactic radiotherapy for non-small cell lung cancer or lung metastasis will benefit from a pre-therapeutic functional assessment including: The standard functional assessment recommended before performing an SBRT. A perfusion PET/CT scan The treatment planning will be carried out in 2 stages: First, an anatomical planning will be carried out, blinded to the PET results. Then, a functional planning, respecting the standard constraints applied during anatomical planning, but also incorporating a new functional lung volume constraint defined by pulmonary PET, will then be carried out. A follow-up will be carried out for 12 months, including repeated perfusion PET/CT imaging at 3 and 12 months | Drug: Pre-therapeutic imaging test<br>* The radiopharmaceutical used for lung perfusion PET consists in human albumin macroaggregates labeled with Ga-68 (68Ga-MAA). 68Ga- MAA are administrated intravenously.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| Dyspnea at Day 0 (inclusion) | Results of EuroQol (EQ-5D-5L) questionnaire | Baseline, Day 0 | 
| Dyspnea at Day 0 (inclusion) | Results of Pulmonary Function testing (PFT) : FEV1 | Baseline, Day 0 | 
| Dyspnea at Day 0 (inclusion) | Results of Pulmonary Function testing (PFT) : FEV1/FVC | Baseline, Day 0 | 
| Dyspnea at Day 0 (inclusion) | Results of 6 minutes Walk Test (6MWT) | Baseline, Day 0 | 
| Dyspnea at 3 months | Results of EuroQol (EQ-5D-5L) questionnaire | At 3 months after SBRT (stereotactic body radiation therapy) | 
| Dyspnea at 3 months | Results of Pulmonary Function testing (PFT) : FEV1 | At 3 months after SBRT (stereotactic body radiation therapy) | 
| Dyspnea at 3 months | Results of Pulmonary Function testing (PFT) : FEV1/FVC | At 3 months after SBRT (stereotactic body radiation therapy) | 
| Dyspnea at 3 months | Results of 6 minutes Walk Test (6MWT) | At 3 months after SBRT (stereotactic body radiation therapy) | 
| Dyspnea at 6 months | Results of EuroQol (EQ-5D-5L) questionnaire | At 6 months after SBRT (stereotactic body radiation therapy) | 
| Dyspnea at 6 months | Results of Pulmonary Function testing (PFT) : FEV1 | At 6 months after SBRT (stereotactic body radiation therapy) | 
| Dyspnea at 6 months | Results of Pulmonary Function testing (PFT) : FEV1/FVC | At 6 months after SBRT (stereotactic body radiation therapy) | 
| Dyspnea at 6 months | Results of 6 minutes Walk Test (6MWT) | At 6 months after SBRT (stereotactic body radiation therapy) | 
| Dyspnea at 9 months | Results of EuroQol (EQ-5D-5L) questionnaire | At 9 months after SBRT (stereotactic body radiation therapy) | 
| Dyspnea at 9 months | Results of Pulmonary Function testing (PFT) : FEV1 | At 9 months after SBRT (stereotactic body radiation therapy) | 
| Dyspnea at 9 months | Results of Pulmonary Function testing (PFT) : FEV1/FVC | At 9 months after SBRT (stereotactic body radiation therapy) | 
| Dyspnea at 9 months | Results of 6 minutes Walk Test (6MWT) | At 9 months after SBRT (stereotactic body radiation therapy) | 
| Dyspnea at 12 months | Results of EuroQol (EQ-5D-5L) questionnaire | At 12 months after SBRT (stereotactic body radiation therapy) | 
| Dyspnea at 12 months | Results of Pulmonary Function testing (PFT) : FEV1 | At 12 months after SBRT (stereotactic body radiation therapy) | 
| Dyspnea at 12 months | Results of Pulmonary Function testing (PFT) : FEV1/FVC | At 12 months after SBRT (stereotactic body radiation therapy) | 
| Dyspnea at 12 months | Results of 6 minutes Walk Test (6MWT) | At 12 months after SBRT (stereotactic body radiation therapy) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SBRT, Radiation induced lung injury, Perfusion imaging, Positron EmissionTomography, Lung cancer