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

NCT07289646 | Not Yet Recruiting Phase 3

• 1 other identifier: 29BRC23.0220
• Study Type: interventional
• Target: 418
• Locations: 1 country
• Sites: 2

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.

Conditions

Stereotactic Body Radiotherapy; 68Ga-MAA; Lung Cancer (Diagnosis)

Keywords

Stereotactic body radiotherapy; 68Ga-MAA lung perfusion; PET/CT; lung radiotherapy

Outcome Measures

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.

  At year after baseline

Secondary Outcomes (7)

• quality of life assessment

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

• quality of life assessment

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

• quality of life assessment

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

• Grade 3 or higher RILI

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

• Local tumor control;

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

Other Outcomes (2)

• Decrease of lung perfusion

  at 3 months after baseline

• Overall survival

  at 12 months after baseline

Study Arms (2)

Control group:

ACTIVE COMPARATOR

A conventional anatomical planning will be performed.

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.

Radiation: Functional Lung avoidance planning

Interventions

Conventional anatomical planning radiotherapy RADIATION

Conventional anatomical planning will be performed

Control group:

Functional Lung avoidance planning RADIATION

Functional Lung Avoidance guided by lung perfusion PET/CT imaging

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to give informed consent
• Patientsunder guardianship or curatorship
• Pregnant or breastfeeding women.
• Contraindications to the radiolabeled product infused for lung perfusion PET/CT.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (2)

CHU Brest

Brest, Finistère, 29200, France

Location

Centre de Lutte Contre le Cancer Leon Bérard Lyon

Lyon, 69000, France

Location

MeSH Terms

Conditions

Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pierre-Yves Le Roux, Professeur

CONTACT

+33 2 98 22 31 17; Pierre-yves.leroux@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 17, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): May 15, 2029
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

FR (2)