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

Study acronym: Pegasus 2
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jan 31, 2029 → Jan 2030
See other at-risk trials from University Hospital, Brest

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Jan 31, 2029 to Jan 2030 Show 6 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Jan 15, 2026 to Sep 4, 2026
    • Primary endpoints: details revised at 1 of 1 entry
    • Study completion pushed from May 15, 2029 to Jan 2030
    • Site details revised at 2 of 2 sites
    • Eligibility criteria expanded, about 5 words
  2. Minor Interventions: CT or 18F FDG PET/CT according to referent physician decision (Diagnostic Test), guided by lung perfusion PET/CT imaging (Diagnostic Test) to Conventional anatomical planning radiotherapy (Radiation), Functional Lung avoidance planning (Radiation)v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07289646
Lead Sponsor University Hospital, Brest
Conditions
(from sponsor)
Stereotactic Body Radiotherapy, 68Ga-MAA, Lung Cancer (Diagnosis)
Related terms Disease, Lung Neoplasms
Enrollment 418 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov