NCT05103670 Ventilation/Perfusion PET/CT With Galligas and 68Ga-MAA for Regional Lung Function Assessment After Pulmonary Embolism
| NCT ID | NCT05103670 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Brest |
| Condition | Pulmonary Embolism |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2023-06-22 |
| Primary Completion | 2025-12-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2023-06-22 with a primary completion date of 2025-12-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 inabi
Frequently Asked Questions
Who can join the NCT05103670 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Pulmonary Embolism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05103670 currently recruiting?
Yes, NCT05103670 is actively recruiting participants. Visit ClinicalTrials.gov or contact University Hospital, Brest to inquire about joining.
Where is the NCT05103670 trial being conducted?
This trial is being conducted at Brest, France.
Who is sponsoring the NCT05103670 clinical trial?
NCT05103670 is sponsored by University Hospital, Brest. The trial plans to enroll 32 participants.