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

NCT04942275 | Unknown Phase 2 DMC

• 1 other identifier: 29BRC21.0131
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

SBRT; Non-small Cell Lung Cancer; Lung Metastasis

Keywords

Perfusion imaging; Positron EmissionTomography; Lung cancer; SBRT; Radiation induced lung injury

Outcome Measures

Primary Outcomes (1)

• Patients with a dose reduction to the functional lung (estimated during functional planning).

  Percentage of patients for whom it is possible to reduce the dose to the functional lung (estimated during the functional planning). A reduction in the dose to the functional lung will be defined by: * A decrease of at least 5% in functional lung volume included in V20Gy. or * A decrease of at least 5% in total relative lung function included in the V20G.

  Baseline, one week after lung perfusion PET / CT scan using Ga68-MAA

Secondary Outcomes (30)

• Impact of lung perfusion PET / CT scan on lung activity during SBRT (stereotactic body radiation therapy) planning

  Baseline, one week after lung perfusion PET / CT scan using Ga68-MAA

• Impact of lung perfusion PET / CT scan on lung activity during SBRT (stereotactic body radiation therapy) planning

  Baseline, one week after lung perfusion PET / CT scan using Ga68-MAA

• Pulmonary toxicity at 3 months

  At 3 months after SBRT (stereotactic body radiation therapy)

• Pulmonary toxicity at 3 months

  At 3 months after SBRT( stereotactic body radiation therapy)

• Pulmonary toxicity at 6 months

  At 6 months after SBRT (stereotactic body radiation therapy)

Study Arms (1)

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

EXPERIMENTAL

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

Drug: Pre-therapeutic imaging test

Interventions

Pre-therapeutic imaging test DRUG

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

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

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, Brest Cedex, 29609, France

Location

Related Publications (1)

• 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.

  PMID: 40591115 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 28, 2021
• Study Start: July 15, 2021
• Primary Completion: July 30, 2022
• Study Completion: September 30, 2023
• Last Updated: September 19, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)