Clinical trial NCT05103670: Ventilation/Perfusion PET/CT With Galligas and 68Ga-MAA for Regional Lung Function Assessment After Pulmonary Embolism
Official title: Ventilation/Perfusion PET/CT With Galligas and 68Ga-MAA for Regional Lung Function Assessment After Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Embolism
Dyspnea
Keywords: Ventilation/perfusion PET/CT
Galligas
68Ga-MAA
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: EOLE is an ancillary study which selects patients included in the RAMBO study. The RAMBO study is a 2-arm-parallel study which patients included in one arm will undergo a 3-month pulmonary rehabilitation, and the patients included in the other arm won't. The EOLE study will include patients in both arms of the RAMBO study. All participants will undergo a PET/CT scan at inclusion and at 3 months.
Primary purpose: BASIC_SCIENCE

Brief 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 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 an acute symptomatic PE diagnosed according the ESC and ACCP guidelines; Patients who have a PembQol score ≥ 10% and whose total scores for the subgroups Q1 (dyspnea) and Q4 (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 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 social security

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

Primary outcomes:
measure: Pulmonary vascular obstruction index (PVOI) on V/Q PET/CT imaging.
timeFrame: 3 months
Secondary outcomes:
measure: Pulmonary ventilation impairment index on V/Q PET/CT imaging.
timeFrame: 3 months
Other outcomes:
Locations:
city: Brest
country: France
facility: LEROUX Pierre-Yves
Study officials:
References: