Functional Lung Avoidance Planning Guided by Lung Perfusion PET/CT Versus Anatomical Planning for Lung Stereotactic Body Radiotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conventional anatomical planning radiotherapy, Functional Lung avoidance planning.
- Who it may be relevant to
- Registry conditions: Stereotactic Body Radiotherapy, 68Ga-MAA, Lung Cancer (Diagnosis). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Stereotactic body radiotherapy (SBRT) has an increasing role in the treatment of both primary and secondary lung tumors. However, lung SBRT remains associated with significant radiation induced lung injury (RILI). Indeed, the reported incidence of symptomatic radiation induced lung injury (grade≥2) in the published literature is up to 20%. A current challenge of lung SBRT is therefore to better preserve lung function and to reduce pulmonary toxicity. During standard lung SBRT planning, dose constraints are defined on the anatomical lung volume. This planning considers the lung as functionally uniform and does not take into account the variability of regional lung function distribution. Functional lung avoidance is an emerging concept in lung radiotherapy (RT). The technique aims at personalizing RT treatment planning to individuals' lung functional distribution, by sparing functional pulmonary areas while prioritizing delivery of high doses to non-functional regions. 68Ga-MAA lung perfusion PET/CT is a novel imaging modality for regional lung function assessment. As compared with conventional lung scintigraphy, lung perfusion PET/CT is inherently a vastly superior technology for image acquisition (higher sensitivity and spatial resolution, greater access to respiratory gated acquisition). A more accurate lung functional mapping improves the possibility of functional lung avoidance planning for SBRT. The hypothesis is that functional lung avoidance planning guided by 68Ga-MAA perfusion PET/CT, while delivering an optimal dose to the tumor, will reduce the frequency of RILI in patients treated with lung SBRT.
Interventions
- Radiation Conventional anatomical planning radiotherapy
Conventional anatomical planning will be performed - Radiation Functional Lung avoidance planning
Functional Lung Avoidance guided by lung perfusion PET/CT imaging
Primary outcome measures
- To determine whether a functional planning guided by lung perfusion PET/CT imaging is superior to a conventional anatomical planning with regards to the occurrence of grade 2 or higher lung toxicity during the year following lung SBRT. [Time frame: At year after baseline]
Secondary outcome measures (7)
- quality of life assessment [Time frame: Measured at 3, 6, 9, and 12 months after baseline]
- quality of life assessment [Time frame: Measured at 3, 6, 9 and 12 months after baseline]
- quality of life assessment [Time frame: Measured at 3, 6, 9, and 12 months after baseline]
- Grade 3 or higher RILI [Time frame: Measured at 3, 6, 9, and 12 months after baseline]
- Local tumor control; [Time frame: Measured at 3, 6, 9, and 12 months after baseline]
- Progression-free survival; [Time frame: Measured at 3, 6, 9, and 12 months after baseline]
- Overall survival. [Time frame: at 12 months after baseline]
Eligibility criteria
Inclusion criteria
- Patients aged > 18 years planned to be treated in the radiotherapy department of the participating centers with SBRT for primary or secondary lung tumors will be eligible to participate into the study
Exclusion criteria
- Inability to give informed consent
- Patientsunder guardianship or curatorship
- Pregnant or breastfeeding women.
- Contraindications to the radiolabeled product infused for lung perfusion PET/CT.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
France · 2 centers
- CHU Brest — Brest
- Centre de Lutte Contre le Cancer Leon Bérard Lyon — Lyon
Identifiers
NCT: NCT07289646 · 29BRC23.0220