Assessing lung function after pulmonary embolism using advanced imaging techniques
Ventilation/Perfusion PET/CT With Galligas and 68Ga-MAA for Regional Lung Function Assessment After Pulmonary Embolism
NA · University Hospital, Brest · NCT05103670
This study is testing advanced imaging techniques to see how well the lungs are working in people who have had a pulmonary embolism and still have trouble breathing, to help improve their rehabilitation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University Hospital, Brest (other) |
| Locations | 1 site (Brest) |
| Trial ID | NCT05103670 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of ventilation/perfusion PET/CT imaging with Galligas and 68Ga-MAA in patients who have experienced pulmonary embolism and continue to suffer from dyspnea despite anticoagulant treatment. The study is part of a larger trial assessing pulmonary rehabilitation's impact on quality of life in these patients. Participants will undergo advanced imaging to assess regional lung function, which may help tailor rehabilitation strategies. The trial is multicenter and randomized, ensuring a robust approach to data collection and analysis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been treated with anticoagulants for 3 to 8 months for acute symptomatic pulmonary embolism and exhibit significant impairment in quality of life.
Not a fit: Patients with chronic thromboembolic pulmonary hypertension (CTEPH), those with active cancer, or individuals whose dyspnea is due to post-COVID conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients suffering from persistent dyspnea after pulmonary embolism.
How similar studies have performed: While this approach is innovative, similar studies using advanced imaging techniques for lung function assessment have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brest
- LEROUX Pierre-Yves — Brest, France (RECRUITING)
Study contacts
- Study coordinator: Pierre-Yves LE ROUX
- Email: pierre-yves.leroux@chu-brest.fr
- Phone: +332 98 22 31 17
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pulmonary Embolism, Dyspnea, Ventilation/perfusion PET/CT, Galligas, 68Ga-MAA