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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Non-small Cell Lung Cancer; Lung Metastasis; SBRT
• Intervention / Treatment: Drug: Pre-therapeutic imaging test

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• France
  • Brest Cedex
    • Brest, Brest Cedex, France, 29609
      • CHRU de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Intervention : Lung perfusion PET/CT using Ga68-MAA and SBRT planification; 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; The radiopharmaceutical used for lung perfusion PET consists in human albumin macroaggregates labeled with Ga-68 (68Ga-MAA). 68Ga- MAA are administrated intravenously.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 15, 2021
• Primary Completion (ACTUAL): July 30, 2022
• Study Completion (ANTICIPATED): September 30, 2023

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 19, 2021
• First Posted (ACTUAL): June 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 16, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Lung cancer; SBRT; Perfusion imaging; Positron EmissionTomography; Radiation induced lung injury
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 29BRC21.0131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No