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

University Hospital, Brest60 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

SBRT Non-small Cell Lung Cancer Lung Metastasis

Interventions

Pre-therapeutic imaging testDRUG

The radiopharmaceutical used for lung perfusion PET consists in human albumin macroaggregates labeled with Ga-68 (68Ga-MAA). 68Ga- MAA are administrated intravenously.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHRU de Brest

Brest, Brest Cedex, France

Outcomes

Primary Outcomes

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.

Time frame: Baseline, one week after lung perfusion PET / CT scan using Ga68-MAA

Secondary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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Time frame: At 3 months after SBRT( stereotactic body radiation therapy)

Pulmonary toxicity at 6 months

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: At 9 months after SBRT (stereotactic body radiation therapy)

Pulmonary toxicity at 12 months

Time frame: 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

Time frame: At 12 months after SBRT (stereotactic body radiation therapy)

Dyspnea at Day 0 (inclusion)

Results of EuroQol (EQ-5D-5L) questionnaire

Time frame: Baseline, Day 0

Dyspnea at Day 0 (inclusion)

Results of Pulmonary Function testing (PFT) : FEV1

Time frame: Baseline, Day 0

Dyspnea at Day 0 (inclusion)

Results of Pulmonary Function testing (PFT) : FEV1/FVC

Time frame: Baseline, Day 0

Dyspnea at Day 0 (inclusion)

Results of 6 minutes Walk Test (6MWT)

Time frame: Baseline, Day 0

Dyspnea at 3 months

Results of EuroQol (EQ-5D-5L) questionnaire

Time frame: At 3 months after SBRT (stereotactic body radiation therapy)

Dyspnea at 3 months

Results of Pulmonary Function testing (PFT) : FEV1

Time frame: At 3 months after SBRT (stereotactic body radiation therapy)

Dyspnea at 3 months

Results of Pulmonary Function testing (PFT) : FEV1/FVC

Time frame: At 3 months after SBRT (stereotactic body radiation therapy)

Dyspnea at 3 months

Results of 6 minutes Walk Test (6MWT)

Time frame: At 3 months after SBRT (stereotactic body radiation therapy)

Dyspnea at 6 months

Results of EuroQol (EQ-5D-5L) questionnaire

Time frame: At 6 months after SBRT (stereotactic body radiation therapy)

Dyspnea at 6 months

Results of Pulmonary Function testing (PFT) : FEV1

Time frame: At 6 months after SBRT (stereotactic body radiation therapy)

Dyspnea at 6 months

Results of Pulmonary Function testing (PFT) : FEV1/FVC

Time frame: At 6 months after SBRT (stereotactic body radiation therapy)

Dyspnea at 6 months

Results of 6 minutes Walk Test (6MWT)

Time frame: At 6 months after SBRT (stereotactic body radiation therapy)

Dyspnea at 9 months

Results of EuroQol (EQ-5D-5L) questionnaire

Time frame: At 9 months after SBRT (stereotactic body radiation therapy)

Dyspnea at 9 months

Results of Pulmonary Function testing (PFT) : FEV1

Time frame: At 9 months after SBRT (stereotactic body radiation therapy)

Dyspnea at 9 months

Results of Pulmonary Function testing (PFT) : FEV1/FVC

Time frame: At 9 months after SBRT (stereotactic body radiation therapy)

Dyspnea at 9 months

Results of 6 minutes Walk Test (6MWT)

Time frame: At 9 months after SBRT (stereotactic body radiation therapy)

Dyspnea at 12 months

Results of EuroQol (EQ-5D-5L) questionnaire

Time frame: At 12 months after SBRT (stereotactic body radiation therapy)

Dyspnea at 12 months

Results of Pulmonary Function testing (PFT) : FEV1

Time frame: At 12 months after SBRT (stereotactic body radiation therapy)

Dyspnea at 12 months

Results of Pulmonary Function testing (PFT) : FEV1/FVC

Time frame: At 12 months after SBRT (stereotactic body radiation therapy)

Dyspnea at 12 months

Results of 6 minutes Walk Test (6MWT)

Time frame: At 12 months after SBRT (stereotactic body radiation therapy)