Lung Perfusion PET / CT Using Ga68-MAA for Preservation of Lung Function During Stereotactic Pulmonary Radiation Therapy

NCT ID: NCT04942275

Last Updated: 2022-09-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-15
• Study Completion Date: 2023-09-30

Brief Summary

This is a prospective study evaluating the feasibility of treatment planning integrating lung perfusion PET/CT using Ga68-MAA to preserve functional lung areas during stereotactic body radiation therapy (SBRT).

Detailed Description

Lung perfusion PET / CT is a new imaging modality based on the use of the same cold molecules as those used for a conventional perfusion lung scan. Similartly, perfusion images are obtained after intravenous administration of human albumin macroaggregates, which are embolized in pulmonary capillaries according to pulmonary blood flow. However, these cold molecules are radiolabeled, not with Technetium99m, but with Gallium68, a ß + isotope, allowing image acquisition with PET technology. The same physiological processes are therefore observed with conventional scintigraphy PET imaging, but PET is an intrinsically superior technique for image acquisition, with greater sensitivity, better spatial and temporal resolutions and the possibility to perform respiratory-gated acquisition, allowing a better definition of the pulmonary functional volumes.

The aim is to evaluate the feasability of functional lung avoidance planification using lung perfusion PET/CT imaging during SBRT.

Patients will benefit from a pre-treatment functional assessment including PET/CT imaging.

The treatment planning will be carried out in 2 stages:

• First, an anatomical planning will be carried out, blinded to the PET results.
• Then, a functional planning, respecting the standard constraints applied during anatomical planning, but also incorporating a new "functional lung volume" constraint defined by PET/CT images, will be carried out.

A follow-up will be carried out for 12 months, including repeated perfusion PET/CT imaging at 3 and 12 months.

Conditions

SBRT; Non-small Cell Lung Cancer; Lung Metastasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention : Lung perfusion PET/CT using Ga68-MAA and SBRT planification

All patients included for treatment with stereotactic radiotherapy for non-small cell lung cancer or lung metastasis will benefit from a pre-therapeutic functional assessment including:

• The standard functional assessment recommended before performing an SBRT.
• A perfusion PET/CT scan

The treatment planning will be carried out in 2 stages:

• First, an anatomical planning will be carried out, blinded to the PET results.
• Then, a functional planning, respecting the standard constraints applied during anatomical planning, but also incorporating a new "functional lung volume" constraint defined by pulmonary PET, will then be carried out.

A follow-up will be carried out for 12 months, including repeated perfusion PET/CT imaging at 3 and 12 months

Group Type: EXPERIMENTAL

Pre-therapeutic imaging test

Intervention Type: DRUG

The radiopharmaceutical used for lung perfusion PET consists in human albumin macroaggregates labeled with Ga-68 (68Ga-MAA). 68Ga- MAA are administrated intravenously.

Interventions

Pre-therapeutic imaging test

The radiopharmaceutical used for lung perfusion PET consists in human albumin macroaggregates labeled with Ga-68 (68Ga-MAA). 68Ga- MAA are administrated intravenously.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age >18 years
• Insured patient
• Patient treated at the Brest CHRU for SBRT of a primary or secondary pulmonary lesion

Exclusion Criteria

• Unable/unwilling to give informed consent
• Pregnancy / breast-feeding patient
• Patient under guardianship or curatorship
• Patient with contraindication to the administration of macroaggregates of human albumin

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHRU de Brest

Brest, Brest Cedex, France

Countries

France

References

Le Roux PY, Le Pennec R, Bourbonne V, Blanc-Beguin F, Pavoine M, Kerleguer K, Mauguen M, Pradier O, Salaun PY, Lucia F, Bourhis D. Pulmonary uptake value (PUV): a new quantification method for lung PET/CT imaging. EJNMMI Res. 2025 Jul 1;15(1):79. doi: 10.1186/s13550-025-01274-y.

Reference Type: DERIVED

PMID: 40591115 (View on PubMed)

Other Identifiers

29BRC21.0131

Identifier Type: -

Identifier Source: org_study_id