Stereotactic Body RadiotherapyPhase 3Pegasus 2NCT07289646
Functional Lung Avoidance Planning Guided by Lung Perfusion PET/CT Versus Anatomical Planning for Lung Stereotactic Body Radiotherapy
A Phase 3 study testing Conventional anatomical planning radiotherapy and Functional Lung avoidance planning in people with Stereotactic Body Radiotherapy and 68Ga-MAA, run by University Hospital, Brest at 2 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stereotactic Body Radiotherapy, 68Ga-MAA, Lung Cancer (Diagnosis)
- What is being tested?
- Conventional anatomical planning radiotherapy and Functional Lung avoidance planning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 418 participants
- Where
- 2 sitesFrance
- Study dates
- 4 Sep 2026to Jan 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHU Brest
Brest, Finistère, 29200
Pierre-Yves Le roux, Professeur, +33 2 98 22 31 17, Pierre-yves.leroux@chu-brest.fr
Pierrre-Yves Le roux, Professeur
- Not yet recruiting
Centre de Lutte Contre le Cancer Leon Bérard Lyon
Lyon, 69000
Vanina Isnardi, +33 478 78 26 83, Vanina.isnardi@lyon.unicancer.fr
About this study
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.
Read more
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.
- Being tested
- Conventional anatomical planning radiotherapy, Functional Lung avoidance planning
- Keywords
- Stereotactic body radiotherapy, 68Ga-MAA lung perfusion, PET/CT, lung radiotherapy
- Medical subject headings
- Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional anatomical planning radiotherapyRadiation
Conventional anatomical planning will be performed
Functional Lung avoidance planningRadiation
Functional Lung Avoidance guided by lung perfusion PET/CT imaging
| Study group | Role | What they receive |
|---|---|---|
| Control group: | Active comparator | A conventional anatomical planning will be performed. Receives: Radiation: Conventional anatomical planning radiotherapy |
| Experimental group | Experimental | functional planning will be carried out, respecting the standard constraints especially to the tumor and the anatomical lung volume, but also incorporating "lung functional volume" constraints defined by regional lung function mapping. Receives: Radiation: Functional Lung avoidance planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At year after baseline
Secondary outcomes (7)
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.
Measured: Measured at 3, 6, 9, and 12 months after baseline
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.
Measured: Measured at 3, 6, 9 and 12 months after baseline
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.
Measured: Measured at 3, 6, 9, and 12 months after baseline
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
Measured: Measured at 3, 6, 9, and 12 months after baseline
Local tumor control;
Local tumor control;
Measured: Measured at 3, 6, 9, and 12 months after baseline
Progression-free survival;
Progression-free survival
Measured: Measured at 3, 6, 9, and 12 months after baseline
Overall survival.
Overall survival
Measured: at 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start4 Sep 2026
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stereotactic Body RadiotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 418 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289646
- Sponsor's protocol ID
- 29BRC23.0220
- Acronym
- Pegasus 2
- Status last verified
- Oct 2026
- First submitted
- 2 Dec 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Lung Avoidance Planning Guided by Lung Perfusion PET/CT Versus Anatomical Planning for Lung Stereotactic Body Radiotherapy
- ClinicalTrials.gov ID
- NCT07289646
- Acronym / sponsor ID
- Pegasus 2 / 29BRC23.0220
- Keywords
- Stereotactic body radiotherapy, 68Ga-MAA lung perfusion, PET/CT, lung radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 418 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 4 Sep 2026 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group: | Active comparator | Radiation: Conventional anatomical planning radiotherapyA conventional anatomical planning will be performed. |
| Experimental group | Experimental | Radiation: Functional Lung avoidance planningfunctional planning will be carried out, respecting the standard constraints especially to the tumor and the anatomical lung volume, but also incorporating "lung functional volume" constraints defined by regional lung function mapping. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- Inability to give informed consent
- Patientsunder guardianship or curatorship
- Pregnant or breastfeeding women.
- Contraindications to the radiolabeled product infused for lung perfusion PET/CT.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional anatomical planning radiotherapyConventional anatomical planning will be performed | Radiation | Control group: |
| Functional Lung avoidance planningFunctional Lung Avoidance guided by lung perfusion PET/CT imaging | Radiation | Experimental group |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Conventional anatomical planning radiotherapy and Functional Lung avoidance planning in people with Stereotactic Body Radiotherapy and 68Ga-MAA, run by University Hospital, Brest at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre-Yves Le Roux, Professeur (+33 2 98 22 31 17, Pierre-yves.leroux@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026; AzTrials last refreshed its copy on 28 Oct 2026.