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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04942275
Acronym
PEGASUS
Enrollment
60
Registered
2021-06-28
Start date
2021-07-15
Completion date
2023-09-30
Last updated
2022-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Metastasis, Non-small Cell Lung Cancer, SBRT

Keywords

Perfusion imaging, Positron EmissionTomography, Lung cancer, SBRT, Radiation induced lung injury

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.

Interventions

DRUGPre-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.

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patients with a dose reduction to the functional lung (estimated during functional planning).Baseline, one week after lung perfusion PET / CT scan using Ga68-MAAPercentage 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

MeasureTime frameDescription
Pulmonary toxicity at 3 monthsAt 3 months after SBRT (stereotactic body radiation therapy)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 6 monthsAt 6 months after SBRT (stereotactic body radiation therapy)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 9 monthsAt 9 months after SBRT (stereotactic body radiation therapy)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 12 monthsAt 12 months after SBRT (stereotactic body radiation therapy)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
Impact of lung perfusion PET / CT scan on lung activity during SBRT (stereotactic body radiation therapy) planningBaseline, one week after lung perfusion PET / CT scan using Ga68-MAAPercentage of activity included in the V20Gy with the anatomical planning and the functional planning.
Dyspnea at 3 monthsAt 3 months after SBRT (stereotactic body radiation therapy)Results of EuroQol (EQ-5D-5L) questionnaire
Dyspnea at 6 monthsAt 6 months after SBRT (stereotactic body radiation therapy)Results of EuroQol (EQ-5D-5L) questionnaire
Dyspnea at 9 monthsAt 9 months after SBRT (stereotactic body radiation therapy)Results of EuroQol (EQ-5D-5L) questionnaire
Dyspnea at 12 monthsAt 12 months after SBRT (stereotactic body radiation therapy)Results of EuroQol (EQ-5D-5L) questionnaire
Dyspnea at Day 0 (inclusion)Baseline, Day 0Results of EuroQol (EQ-5D-5L) questionnaire

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026