Ventilation/Perfusion PET/CT With Galligas and 68Ga-MAA for Regional Lung Function Assessment After Pulmonary Embolism
NCT ID: NCT05103670
Last Updated: 2025-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
32 participants
INTERVENTIONAL
2023-06-22
2025-12-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Impact on Quality of Life with Pulmonary RehAbilitation After Pulmonary EMBOlism: RAMBO Study
NCT05015153
Residual Pulmonary Vascular Obstruction Index Computed with Ventilation/perfusion SPECT/CT Imaging to Predict the Risk of Venous Thromboembolism Recurrence in Patients with Pulmonary Embolism (PRONOSPECT)
NCT06372730
Molecular Imaging of Active Venous Thrombus With Positron Emission Tomography (PET)
NCT06057844
Comparison of 3 Diagnostic Strategies of PE: Planar V/Q Scan, CTPA, and V/Q SPECT.
NCT02983760
Ga68 V/Q PET/CT for Pulmonary Embolism Diagnosis: a Diagnostic Accuracy Study vs CT Pulmonary Angiography
NCT04179539
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients undergoing a Ventilation/Perfusion PET/CT at inclusion and 3 months later
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 specific patients in both arms of the RAMBO study, and all of the participants will undergo a PET/CT scan at the inclusion and 3 months later.
Ventilation/Perfusion PET/CT with Galligas and 68Ga-MAA
32 patients will undergo a Ventilation/Perfusion PET/CT with Galligas and 68Ga-MAA at the inclusion and 3 months later.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ventilation/Perfusion PET/CT with Galligas and 68Ga-MAA
32 patients will undergo a Ventilation/Perfusion PET/CT with Galligas and 68Ga-MAA at the inclusion and 3 months later.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Abnormal conventional V/Q scan at V1
* Give consent to participate to the EOLE study
* 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
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Brest
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
LEROUX Pierre-Yves
Brest, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
29BRC21.0139 (EOLE)
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.