Ventilation/Perfusion PET/CT With Galligas and 68Ga-MAA for Regional Lung Function Assessment Aft… (NCT05103670) | Clinical Trial Compass
RecruitingNot Applicable
Ventilation/Perfusion PET/CT With Galligas and 68Ga-MAA for Regional Lung Function Assessment After Pulmonary Embolism
France32 participantsStarted 2023-06-22
Plain-language 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.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 und…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pulmonary vascular obstruction index (PVOI) on V/Q PET/CT imaging.