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

Non-small Cell Lung Cancer Clinical Trial

— PEGASUS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04942275
• Other study ID #: 29BRC21.0131
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: July 15, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: September 2022
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Metastasis
• Lung Neoplasms
• Non-small Cell Lung Cancer
• SBRT

Intervention

Drug:
• Pre-therapeutic imaging test
The radiopharmaceutical used for lung perfusion PET consists in human albumin macroaggregates labeled with Ga-68 (68Ga-MAA). 68Ga- MAA are administrated intravenously.

Locations

Country	Name	City	State
France	CHRU de Brest	Brest	Brest Cedex

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

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)