68Ga-MAA, Lung Cancer (Diagnosis), Stereotactic Body Radiotherapy
Conditions
Keywords
Stereotactic body radiotherapy, 68Ga-MAA lung perfusion, PET/CT, lung radiotherapy
Brief summary
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
RADIATIONConventional anatomical planning radiotherapy
Conventional anatomical planning will be performed
RADIATIONFunctional Lung avoidance planning
Functional Lung Avoidance guided by lung perfusion PET/CT imaging
Sponsors
University Hospital, Brest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | At year after baseline | Occurrence of symptomatic RILI (grade≥2 lung toxicity as assessed using the CTCAE 5.0) during the year following lung SBRT. This evaluation will be performed by a medical oncologist blinded from the allocated arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| quality of life assessment | Measured at 3, 6, 9, and 12 months after baseline | Quality of life as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), with scores ranging from 0 to 100; higher scores indicate better quality of life for the global health status and functional scales, and worse symptoms for the symptom scales. |
| Grade 3 or higher RILI | Measured at 3, 6, 9, and 12 months after baseline | Lung toxicity as assessed using the CTCAE 5.0, RTOG and Late effects in normal tissue-subjective objective management analysis (LENT-SOMA) scales |
| Local tumor control; | Measured at 3, 6, 9, and 12 months after baseline | Local tumor control; |
| Progression-free survival; | Measured at 3, 6, 9, and 12 months after baseline | Progression-free survival |
| Overall survival. | at 12 months after baseline | Overall survival |
Other
| Measure | Time frame | Description |
|---|---|---|
| Decrease of lung perfusion | at 3 months after baseline | Lung perfusion PET/CT imaging |
| Overall survival | at 12 months after baseline | Grade≥2 lung toxicity during the year following lung SBRT |
Countries
France
Contacts
Primary ContactPierre-Yves Le Roux, Professeur
Outcome results
None listed