Functional Lung Avoidance Planning Guided by Lung Perfusion PET/CT Versus Anatomical Planning for Lung Stereotactic Body Radiotherapy

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Brest

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Inability to give informed consent

Patientsunder guardianship or curatorship

Pregnant or breastfeeding women.

Contraindications to the radiolabeled product infused for lung perfusion PET/CT.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conventional anatomical planning radiotherapy

    Radiation

    Conventional anatomical planning will be performed

  • Functional Lung avoidance planning

    Radiation

    Functional Lung Avoidance guided by lung perfusion PET/CT imaging

Treatment groups

418 Participants
are divided into 2 treatment groups
Group A: Control group:Active comparator 1 intervention
Group B: Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

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.

Time frame
At year after baseline

Secondary outcomes

1

quality of life assessment

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.

Time frame
Measured at 3, 6, 9, and 12 months after baseline
2

quality of life assessment

Quality of life as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC29), with scores ranging from 0 to 100; higher scores indicate worse symptom burden.

Time frame
Measured at 3, 6, 9 and 12 months after baseline
3

quality of life assessment

Quality of life as assessed by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire, with index values ranging from -0.594 to 1.0, where higher scores indicate better health-related quality of life.

Time frame
Measured at 3, 6, 9, and 12 months after baseline
4

Grade 3 or higher RILI

Lung toxicity as assessed using the CTCAE 5.0, RTOG and Late effects in normal tissue-subjective objective management analysis (LENT-SOMA) scales

Time frame
Measured at 3, 6, 9, and 12 months after baseline

Other outcomes

1

Decrease of lung perfusion

Lung perfusion PET/CT imaging

Time frame
at 3 months after baseline
2

Overall survival

Grade≥2 lung toxicity during the year following lung SBRT

Time frame
at 12 months after baseline

Sponsors and contacts

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