Actively Recruiting
Ventilation/Perfusion PET/CT With Galligas and 68Ga-MAA for Regional Lung Function Assessment After Pulmonary Embolism
Led by University Hospital, Brest · Updated on 2025-02-05
32
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ventilation/Perfusion PET/CT With Galligas and 68Ga-MAA for Regional Lung Function Assessment After Pulmonary Embolism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient included in the RAMBO study: age 18 years or older
- Treated with anticoagulants for at least 3 months and up to 8 months for acute symptomatic pulmonary embolism diagnosed by ESC and ACCP guidelines
- PembQol score 10% or higher, with sub-scores for dyspnea and impact on daily life 10% or higher
- Planned to be randomized in the study
- Abnormal conventional V/Q scan at initial visit
- Provided consent to participate in the EOLE study
You will not qualify if you...
- Not meeting RAMBO trial inclusion criteria
- Unable to perform exercise test or pulmonary rehabilitation
- Presence of chronic thromboembolic pulmonary hypertension (CTEPH)
- Treated with anticoagulants for acute PE for more than 8 months
- Active cancer or cancer remission less than two years
- Breathlessness after COVID-19 due to lung tissue damage
- Post-COVID hyperventilation syndrome without lung blood flow problems
- Physical or psychological inability to do pulmonary rehabilitation
- Isolated or distal segmental pulmonary embolism
- Neuromuscular disease preventing pulmonary rehabilitation
- Unstable heart failure or severe respiratory failure
- Chronic breathlessness MMRC score 2 or higher before PE
- Cardiac or respiratory rehabilitation in the past year
- Need for urgent pulmonary rehabilitation within 6 months
- Life expectancy less than 12 months
- Unable to give consent
- Under guardianship or curatorship
- Deprived of liberty by administrative or judicial decision
- No social security affiliation or benefits
- After pulmonary rehabilitation evaluation: inability to perform exercise test, exercise test stopped due to hemodynamic intolerance, newly discovered heart failure
AI-Screening
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Trial Site Locations
Total: 1 location
1
LEROUX Pierre-Yves
Brest, France, 29200
Actively Recruiting
Research Team
P
Pierre-Yves LE ROUX
CONTACT
P
Pierre-Yves SALAUN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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