Pulmonary EmbolismEOLENCT05103670
Ventilation/Perfusion PET/CT With Galligas and 68Ga-MAA for Regional Lung Function Assessment After Pulmonary Embolism
A study testing Ventilation/Perfusion PET/CT with Galligas and 68Ga-MAA in people with Pulmonary Embolism and Dyspnea, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pulmonary Embolism, Dyspnea
- What is being tested?
- Ventilation/Perfusion PET/CT with Galligas and 68Ga-MAA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jun 2023to 22 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
LEROUX Pierre-Yves
Brest, 29200
Pierre-Yves LEROUX, +332 98 22 31 17, pierre-yves.leroux@chu-brest.fr
Pierre-Yves SALAUN, +332 98 22 39 64, pierre-yves.salaun@chu-brest.fr
About this study
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.
Read more
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
- Pulmonary Embolism, Dyspnea
- Being tested
- Ventilation/Perfusion PET/CT with Galligas and 68Ga-MAA
- Keywords
- Ventilation/perfusion PET/CT, Galligas, 68Ga-MAA
- Medical subject headings
- Pulmonary Embolism, Dyspnea, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilation/Perfusion PET/CT with Galligas and 68Ga-MAAProcedure or surgery
32 patients will undergo a Ventilation/Perfusion PET/CT with Galligas and 68Ga-MAA at the inclusion and 3 months later.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing a Ventilation/Perfusion PET/CT at inclusion and 3 months later | Experimental | 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. Receives: Procedure: Ventilation/Perfusion PET/CT with Galligas and 68Ga-MAA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary vascular obstruction index (PVOI) on V/Q PET/CT imaging.
Expressed as a percentage of whole lung
Measured: 3 months
Secondary outcomes (1)
Pulmonary ventilation impairment index on V/Q PET/CT imaging.
Expressed as a percentage of whole lung
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start22 Jun 2023
- Primary completion22 Dec 2026 (estimated)
- Study completion22 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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 patients in both arms of the RAMBO study. All participants will undergo a PET/CT scan at inclusion and at 3 months.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103670
- Sponsor's protocol ID
- 29BRC21.0139 (EOLE)
- Acronym
- EOLE
- Status last verified
- Jun 2026
- First submitted
- 21 Oct 2021
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilation/Perfusion PET/CT With Galligas and 68Ga-MAA for Regional Lung Function Assessment After Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT05103670
- Acronym / sponsor ID
- EOLE / 29BRC21.0139 (EOLE)
- Conditions
- Pulmonary Embolism, Dyspnea
- Keywords
- Ventilation/perfusion PET/CT, Galligas, 68Ga-MAA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 22 Dec 2026 (estimated)
- Study completion
- 22 Dec 2026 (estimated)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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 patients in both arms of the RAMBO study. All participants will undergo a PET/CT scan at inclusion and at 3 months.
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing a Ventilation/Perfusion PET/CT at inclusion and 3 months later | Experimental | Procedure: Ventilation/Perfusion PET/CT with Galligas and 68Ga-MAAEOLE 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventilation/Perfusion PET/CT with Galligas and 68Ga-MAA32 patients will undergo a Ventilation/Perfusion PET/CT with Galligas and 68Ga-MAA at the inclusion and 3 months later. | Procedure or surgery | Patients undergoing a Ventilation/Perfusion PET/CT at inclusion and 3 months later |
Primary outcome
Pulmonary vascular obstruction index (PVOI) on V/Q PET/CT imaging.
Time frame: 3 months
Expressed as a percentage of whole lung
1 secondary outcome
Pulmonary ventilation impairment index on V/Q PET/CT imaging.
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilation/Perfusion PET/CT with Galligas and 68Ga-MAA in people with Pulmonary Embolism and Dyspnea, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre-Yves LE ROUX (+332 98 22 31 17, pierre-yves.leroux@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary vascular obstruction index (PVOI) on V/Q PET/CT imaging. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.