Clinical trial NCT04942275: Lung Perfusion PET / CT Using Ga68-MAA for Preservation of Lung Function During Stereotactic Pulmonary Radiation Therapy
Official title: Lung Perfusion PET / CT Using Gallium68-MMA for Preservation of Lung Function During Stereotactic Pulmonary Radiation Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: SBRT
Non-small Cell Lung Cancer
Lung Metastasis
Keywords: Perfusion imaging
Positron EmissionTomography
Lung cancer
SBRT
Radiation induced lung injury
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Patients with a dose reduction to the functional lung (estimated during functional planning).
timeFrame: Baseline, one week after lung perfusion PET / CT scan using Ga68-MAA
Secondary outcomes:
measure: Impact of lung perfusion PET / CT scan on lung activity during SBRT (stereotactic body radiation therapy) planning
timeFrame: Baseline, one week after lung perfusion PET / CT scan using Ga68-MAA
measure: Impact of lung perfusion PET / CT scan on lung activity during SBRT (stereotactic body radiation therapy) planning
timeFrame: Baseline, one week after lung perfusion PET / CT scan using Ga68-MAA
measure: Pulmonary toxicity at 3 months
timeFrame: At 3 months after SBRT (stereotactic body radiation therapy)
measure: Pulmonary toxicity at 3 months
timeFrame: At 3 months after SBRT( stereotactic body radiation therapy)
measure: Pulmonary toxicity at 6 months
timeFrame: At 6 months after SBRT (stereotactic body radiation therapy)
measure: Pulmonary toxicity at 6 months
timeFrame: At 6 months after SBRT (stereotactic body radiation therapy)
measure: Pulmonary toxicity at 9 months
timeFrame: At 9 months after SBRT (stereotactic body radiation therapy)
measure: Pulmonary toxicity at 9 months
timeFrame: At 9 months after SBRT (stereotactic body radiation therapy)
measure: Pulmonary toxicity at 12 months
timeFrame: At 12 months after SBRT (stereotactic body radiation therapy)
measure: Pulmonary toxicity at 12 months
timeFrame: At 12 months after SBRT (stereotactic body radiation therapy)
measure: Dyspnea at Day 0 (inclusion)
timeFrame: Baseline, Day 0
measure: Dyspnea at Day 0 (inclusion)
timeFrame: Baseline, Day 0
measure: Dyspnea at Day 0 (inclusion)
timeFrame: Baseline, Day 0
measure: Dyspnea at Day 0 (inclusion)
timeFrame: Baseline, Day 0
measure: Dyspnea at 3 months
timeFrame: At 3 months after SBRT (stereotactic body radiation therapy)
measure: Dyspnea at 3 months
timeFrame: At 3 months after SBRT (stereotactic body radiation therapy)
measure: Dyspnea at 3 months
timeFrame: At 3 months after SBRT (stereotactic body radiation therapy)
measure: Dyspnea at 3 months
timeFrame: At 3 months after SBRT (stereotactic body radiation therapy)
measure: Dyspnea at 6 months
timeFrame: At 6 months after SBRT (stereotactic body radiation therapy)
measure: Dyspnea at 6 months
timeFrame: At 6 months after SBRT (stereotactic body radiation therapy)
measure: Dyspnea at 6 months
timeFrame: At 6 months after SBRT (stereotactic body radiation therapy)
measure: Dyspnea at 6 months
timeFrame: At 6 months after SBRT (stereotactic body radiation therapy)
measure: Dyspnea at 9 months
timeFrame: At 9 months after SBRT (stereotactic body radiation therapy)
measure: Dyspnea at 9 months
timeFrame: At 9 months after SBRT (stereotactic body radiation therapy)
measure: Dyspnea at 9 months
timeFrame: At 9 months after SBRT (stereotactic body radiation therapy)
measure: Dyspnea at 9 months
timeFrame: At 9 months after SBRT (stereotactic body radiation therapy)
measure: Dyspnea at 12 months
timeFrame: At 12 months after SBRT (stereotactic body radiation therapy)
measure: Dyspnea at 12 months
timeFrame: At 12 months after SBRT (stereotactic body radiation therapy)
measure: Dyspnea at 12 months
timeFrame: At 12 months after SBRT (stereotactic body radiation therapy)
measure: Dyspnea at 12 months
timeFrame: At 12 months after SBRT (stereotactic body radiation therapy)
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
state: Brest Cedex
Study officials:
References: