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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

418 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-15

Study Completion Date

2029-05-15

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control group:

A conventional anatomical planning will be performed.

Group Type ACTIVE_COMPARATOR

Conventional anatomical planning radiotherapy

Intervention Type RADIATION

Conventional anatomical planning will be performed

Experimental group

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.

Group Type EXPERIMENTAL

Functional Lung avoidance planning

Intervention Type RADIATION

Functional Lung Avoidance guided by lung perfusion PET/CT imaging

Interventions

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Conventional anatomical planning radiotherapy

Conventional anatomical planning will be performed

Intervention Type RADIATION