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NCT Number: NCT07289646

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Brest, Brest, Finistère, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

    Time frame: 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 outcomes

  1. quality of life assessment

    Time frame: 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.

  2. quality of life assessment

    Time frame: 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 Lung Cancer Module (EORTC QLQ-LC29), with scores ranging from 0 to 100; higher scores indicate worse symptom burden.

  3. quality of life assessment

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

    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.

  4. Grade 3 or higher RILI

    Time frame: 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

  5. Local tumor control;

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

    Local tumor control;

  6. Progression-free survival;

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

    Progression-free survival

  7. Overall survival.

    Time frame: at 12 months after baseline

    Overall survival

Other outcomes

  1. Decrease of lung perfusion

    Time frame: at 3 months after baseline

    Lung perfusion PET/CT imaging

  2. Overall survival

    Time frame: at 12 months after baseline

    Grade≥2 lung toxicity during the year following lung SBRT

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre-Yves Le Roux, Professeur

CONTACT

[email protected]

+33 2 98 22 31 17

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: Pegasus 2

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Dec 17, 2025
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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