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

Primary Purpose

SBRT, Non-small Cell Lung Cancer, Lung Metastasis

Status
Active
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Pre-therapeutic imaging test
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for SBRT focused on measuring Perfusion imaging, Positron EmissionTomography, Lung cancer, SBRT, Radiation induced lung injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU de Brest

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention : Lung perfusion PET/CT using Ga68-MAA and SBRT planification

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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
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
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
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
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
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
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
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
Dyspnea at Day 0 (inclusion)
Results of EuroQol (EQ-5D-5L) questionnaire
Dyspnea at Day 0 (inclusion)
Results of Pulmonary Function testing (PFT) : FEV1
Dyspnea at Day 0 (inclusion)
Results of Pulmonary Function testing (PFT) : FEV1/FVC
Dyspnea at Day 0 (inclusion)
Results of 6 minutes Walk Test (6MWT)
Dyspnea at 3 months
Results of EuroQol (EQ-5D-5L) questionnaire
Dyspnea at 3 months
Results of Pulmonary Function testing (PFT) : FEV1
Dyspnea at 3 months
Results of Pulmonary Function testing (PFT) : FEV1/FVC
Dyspnea at 3 months
Results of 6 minutes Walk Test (6MWT)
Dyspnea at 6 months
Results of EuroQol (EQ-5D-5L) questionnaire
Dyspnea at 6 months
Results of Pulmonary Function testing (PFT) : FEV1
Dyspnea at 6 months
Results of Pulmonary Function testing (PFT) : FEV1/FVC
Dyspnea at 6 months
Results of 6 minutes Walk Test (6MWT)
Dyspnea at 9 months
Results of EuroQol (EQ-5D-5L) questionnaire
Dyspnea at 9 months
Results of Pulmonary Function testing (PFT) : FEV1
Dyspnea at 9 months
Results of Pulmonary Function testing (PFT) : FEV1/FVC
Dyspnea at 9 months
Results of 6 minutes Walk Test (6MWT)
Dyspnea at 12 months
Results of EuroQol (EQ-5D-5L) questionnaire
Dyspnea at 12 months
Results of Pulmonary Function testing (PFT) : FEV1
Dyspnea at 12 months
Results of Pulmonary Function testing (PFT) : FEV1/FVC
Dyspnea at 12 months
Results of 6 minutes Walk Test (6MWT)

Full Information

First Posted
June 9, 2021
Last Updated
September 16, 2022
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT04942275
Brief Title
Lung Perfusion PET / CT Using Ga68-MAA for Preservation of Lung Function During Stereotactic Pulmonary Radiation Therapy
Acronym
PEGASUS
Official Title
Lung Perfusion PET / CT Using Gallium68-MMA for Preservation of Lung Function During Stereotactic Pulmonary Radiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SBRT, Non-small Cell Lung Cancer, Lung Metastasis
Keywords
Perfusion imaging, Positron EmissionTomography, Lung cancer, SBRT, Radiation induced lung injury

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention : Lung perfusion PET/CT using Ga68-MAA and SBRT planification
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Pre-therapeutic imaging test
Intervention Description
The radiopharmaceutical used for lung perfusion PET consists in human albumin macroaggregates labeled with Ga-68 (68Ga-MAA). 68Ga- MAA are administrated intravenously.
Primary Outcome Measure Information:
Title
Patients with a dose reduction to the functional lung (estimated during functional planning).
Description
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 Outcome Measure Information:
Title
Impact of lung perfusion PET / CT scan on lung activity during SBRT (stereotactic body radiation therapy) planning
Description
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
Title
Impact of lung perfusion PET / CT scan on lung activity during SBRT (stereotactic body radiation therapy) planning
Description
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
Title
Pulmonary toxicity at 3 months
Description
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)
Title
Pulmonary toxicity at 3 months
Description
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
Time Frame
At 3 months after SBRT( stereotactic body radiation therapy)
Title
Pulmonary toxicity at 6 months
Description
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
Time Frame
At 6 months after SBRT (stereotactic body radiation therapy)
Title
Pulmonary toxicity at 6 months
Description
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)
Title
Pulmonary toxicity at 9 months
Description
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)
Title
Pulmonary toxicity at 9 months
Description
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)
Title
Pulmonary toxicity at 12 months
Description
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
Time Frame
At 12 months after SBRT (stereotactic body radiation therapy)
Title
Pulmonary toxicity at 12 months
Description
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)
Title
Dyspnea at Day 0 (inclusion)
Description
Results of EuroQol (EQ-5D-5L) questionnaire
Time Frame
Baseline, Day 0
Title
Dyspnea at Day 0 (inclusion)
Description
Results of Pulmonary Function testing (PFT) : FEV1
Time Frame
Baseline, Day 0
Title
Dyspnea at Day 0 (inclusion)
Description
Results of Pulmonary Function testing (PFT) : FEV1/FVC
Time Frame
Baseline, Day 0
Title
Dyspnea at Day 0 (inclusion)
Description
Results of 6 minutes Walk Test (6MWT)
Time Frame
Baseline, Day 0
Title
Dyspnea at 3 months
Description
Results of EuroQol (EQ-5D-5L) questionnaire
Time Frame
At 3 months after SBRT (stereotactic body radiation therapy)
Title
Dyspnea at 3 months
Description
Results of Pulmonary Function testing (PFT) : FEV1
Time Frame
At 3 months after SBRT (stereotactic body radiation therapy)
Title
Dyspnea at 3 months
Description
Results of Pulmonary Function testing (PFT) : FEV1/FVC
Time Frame
At 3 months after SBRT (stereotactic body radiation therapy)
Title
Dyspnea at 3 months
Description
Results of 6 minutes Walk Test (6MWT)
Time Frame
At 3 months after SBRT (stereotactic body radiation therapy)
Title
Dyspnea at 6 months
Description
Results of EuroQol (EQ-5D-5L) questionnaire
Time Frame
At 6 months after SBRT (stereotactic body radiation therapy)
Title
Dyspnea at 6 months
Description
Results of Pulmonary Function testing (PFT) : FEV1
Time Frame
At 6 months after SBRT (stereotactic body radiation therapy)
Title
Dyspnea at 6 months
Description
Results of Pulmonary Function testing (PFT) : FEV1/FVC
Time Frame
At 6 months after SBRT (stereotactic body radiation therapy)
Title
Dyspnea at 6 months
Description
Results of 6 minutes Walk Test (6MWT)
Time Frame
At 6 months after SBRT (stereotactic body radiation therapy)
Title
Dyspnea at 9 months
Description
Results of EuroQol (EQ-5D-5L) questionnaire
Time Frame
At 9 months after SBRT (stereotactic body radiation therapy)
Title
Dyspnea at 9 months
Description
Results of Pulmonary Function testing (PFT) : FEV1
Time Frame
At 9 months after SBRT (stereotactic body radiation therapy)
Title
Dyspnea at 9 months
Description
Results of Pulmonary Function testing (PFT) : FEV1/FVC
Time Frame
At 9 months after SBRT (stereotactic body radiation therapy)
Title
Dyspnea at 9 months
Description
Results of 6 minutes Walk Test (6MWT)
Time Frame
At 9 months after SBRT (stereotactic body radiation therapy)
Title
Dyspnea at 12 months
Description
Results of EuroQol (EQ-5D-5L) questionnaire
Time Frame
At 12 months after SBRT (stereotactic body radiation therapy)
Title
Dyspnea at 12 months
Description
Results of Pulmonary Function testing (PFT) : FEV1
Time Frame
At 12 months after SBRT (stereotactic body radiation therapy)
Title
Dyspnea at 12 months
Description
Results of Pulmonary Function testing (PFT) : FEV1/FVC
Time Frame
At 12 months after SBRT (stereotactic body radiation therapy)
Title
Dyspnea at 12 months
Description
Results of 6 minutes Walk Test (6MWT)
Time Frame
At 12 months after SBRT (stereotactic body radiation therapy)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHRU de Brest
City
Brest
State/Province
Brest Cedex
ZIP/Postal Code
29609
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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