Lung Perfusion PET / CT Using Ga68-MAA for Preservation of Lung Function During Stereotactic Pulmonary Radiation Therapy
- Conditions
- Non-small Cell Lung CancerLung MetastasisSBRT
- Interventions
- Drug: Pre-therapeutic imaging test
- Registration Number
- NCT04942275
- Lead Sponsor
- University Hospital, Brest
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Age >18 years
- Insured patient
- Patient treated at the Brest CHRU for SBRT of a primary or secondary pulmonary lesion
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention : Lung perfusion PET/CT using Ga68-MAA and SBRT planification Pre-therapeutic imaging test 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
- Primary Outcome Measures
Name Time Method Patients with a dose reduction to the functional lung (estimated during functional planning). Baseline, one week after lung perfusion PET / CT scan using Ga68-MAA 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
Name Time Method Pulmonary toxicity at 3 months At 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-LC13 :European Organisation for Research and Treatment of Cancer- Quality of Life Questionnaire - Lung Cancer module 13) at 3 months
Impact of lung perfusion PET / CT scan on lung activity during SBRT (stereotactic body radiation therapy) planning Baseline, one week after lung perfusion PET / CT scan using Ga68-MAA Percentage of functional lung volume included in the V20Gy with anatomical planning and during functional planning
Pulmonary toxicity at 6 months At 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-LC13 : European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - Lung Cancer module 13) at 6 months
Dyspnea at 3 months At 3 months after SBRT (stereotactic body radiation therapy) Results of 6 minutes Walk Test (6MWT)
Dyspnea at 6 months At 6 months after SBRT (stereotactic body radiation therapy) Results of 6 minutes Walk Test (6MWT)
Dyspnea at 9 months At 9 months after SBRT (stereotactic body radiation therapy) Results of 6 minutes Walk Test (6MWT)
Pulmonary toxicity at 9 months At 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-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 At 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-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) Baseline, Day 0 Results of 6 minutes Walk Test (6MWT)
Dyspnea at 12 months At 12 months after SBRT (stereotactic body radiation therapy) Results of 6 minutes Walk Test (6MWT)
Trial Locations
- Locations (1)
CHRU de Brest
🇫🇷Brest, Brest Cedex, France