Ventilation/Perfusion PET/CT with Galligas and 68Ga-MAA for Regional Lung Function Assessment After Pulmonary Embolism

Phase

N/A

Condition

Lung Injury

Lung Disease

Chest Pain

Treatment

Ventilation/Perfusion PET/CT with Galligas and 68Ga-MAA

Clinical Study ID

NCT05103670

29BRC21.0139 (EOLE)

Ages 18-99
All Genders

Study Summary

In patients with pulmonary embolism (PE), after three or six months of anticoagulation, persistent dyspnea and impairment of quality of life are observed in at least 30% of cases.

The "RAMBO" trial is a French academic, multicenter, randomized (1:1 ratio), parallel arm, controlled, that aimed to assess the efficacy of pulmonary rehabilitation (PR) on the quality of life in patients with an acute symptomatic PE treated with anticoagulant therapy during at least 3 months and who present an impairment of quality of life and/or persistent dyspnea despite anticoagulant therapy.

Ventilation/Perfusion (V/Q) PET/CT is a novel imaging modality for the assessment of regional lung function. The same carrier molecules as conventional V/Q imaging are used, but they are labeled with 68Gallium, a ß+ isotope, instead of 99mTc, allowing acquisition of images with PET technology.

The EOLE study is an ancillary pilot study of the RAMBO trial, in which patients will benefit, in addition to the extensive work up scheduled as per study protocol, from a V/Q PET/CT scan before and after PR. The aim of the study is to assess the impact of PR on regional lung function with lung V/Q PET/CT imaging.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patient included in the RAMBO study, whose inclusion criteria are: Age ≥ 18 years;Patient treated with at least 3 months and up to 8 months of anticoagulation for anacute symptomatic PE diagnosed according the ESC and ACCP guidelines; Patients whohave a PembQol score ≥ 10% and whose total scores for the subgroups Q1 (dyspnea) andQ4 (impact of daily life) are ≥ 10%.
Patients planned to be randomized
Abnormal conventional V/Q scan at V1
Give consent to participate to the EOLE study

Exclusion

Exclusion Criteria:

Non inclusion criteria of the RAMBO trial:
Previsible inability to perform the effort test and/or PR
Presence of CTEPH according to international guidelines
Patients treated for acute PE with anticoagulants for more than 8 months
Active cancer or in remission for less than two years
Dyspnea post - COVID due to parenchymal injuries
Post-COVID hyperventilation syndrome without pulmonary vascular perfusion sequelae
Physical or psychological inability to undertake PR
Isolated or more distal segmental PE
Neuro-muscular disease with PR contraindication.
Cardiac insufficiency (unstable coronary artery disease)
Severe respiratory failure (long-term oxygen therapy, pulmonary hypertension)
Chronic dyspnea MMRC ≥ 2 before PE
Cardiac or respiratory rehabilitation in the previous year
Indication to urgent PR within 6 months at the time of inclusion
Life expectancy of less than 12 months
Inability to give consent
Patient under guardianship or curatorship
Patient deprived of liberty by an administrative or judicial decision
Patient has not social security affiliation or who don't beneficiary of such socialsecurity

After initial PR work up, patients with following criteria cannot be included:

Incapacity to perform the effort test
Effort test stopped because of hemodynamic intolerance
Cardiac failure discovered after PR work up

Study Design

Ventilation/Perfusion PET/CT with Galligas and 68Ga-MAA

June 22, 2023

December 22, 2025

Connect with a study center

LEROUX Pierre-Yves
Brest, 29200
France
Active - Recruiting

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