ClinicalTrials.gg
RecruitingNCT05103670EOLEUpdated Jun 16, 2026

Ventilation/Perfusion PET/CT With Galligas and 68Ga-MAA for Regional Lung Function Assessment After Pulmonary Embolism

An interventional study of Ventilation/Perfusion PET/CT with Galligas and 68Ga-MAA in Pulmonary Embolism and Dyspnea, sponsored by University Hospital, Brest. Recruiting at 1 site in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by University Hospital, Brest · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Jun 2023; still recruiting 3 years 4 months later.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 20 studies in Pulmonary Embolism by University Hospital, Brest — 5 open to participants now, 6 under way, none of them phase 3. Pulmonary Embolism · University Hospital, Brest.

Planned enrollment
10th of 11
32 · median 374
Started
2023
the only one that year
No phase
10 of 20
4 open now
Registered
16th of 20
by date

Among the 20 studies in Pulmonary Embolism by University Hospital, Brest, this one is the 10th largest by planned enrollment of the 11 interventional ones that give a count, is the only one that started in 2023, is one of 10 with no phase, and was the 16th registered.

Pulmonary Embolism

832 studies on the registry are indexed under Pulmonary Embolism; 171 are open to participants now.

Browse Pulmonary Embolism studies →

Open to participants now

5 of the 20 studies in Pulmonary Embolism by University Hospital, Brest are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Where they have run

Who these studies take

Of the 129 Pulmonary Embolism studies recruiting now, 109 (84%) set no upper age limit and 5 (4%) stop at 75 or younger; 9 take children under 18; 9 take healthy volunteers.

This study: 18 Years to 99 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 20 studies in Pulmonary Embolism by University Hospital, Brest, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Pulmonary Embolism
  • Dyspnea

Keywords

  • Ventilation/perfusion PET/CT
  • Galligas
  • 68Ga-MAA
04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 .
  • 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
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    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.

    Procedure: Ventilation/Perfusion PET/CT with Galligas and 68Ga-MAA

Interventions

  • ProcedureVentilation/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.

06

What researchers measure

Primary outcomes

  1. Pulmonary vascular obstruction index (PVOI) on V/Q PET/CT imaging.

    Expressed as a percentage of whole lung

    Time frame: 3 months

Secondary outcomes

  1. Pulmonary ventilation impairment index on V/Q PET/CT imaging.

    Expressed as a percentage of whole lung

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • LEROUX Pierre-Yves
    Brest, 29200, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — All collected data that underlie results in a publication

Supporting information: Study protocol

Time frame: Data will be available beginning five years and ending fifteen years following the final study report completion

Access criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2023 (actual). Primary completion is estimated for Dec 2026, 42 months after the start.

Of 125 non-industry interventional studies with no phase under Pulmonary Embolism, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 55. This study's planned 42 months is above that.

Counting every sponsor, half of 150 studies reached it within 25 months; a quarter within 15 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 21, 2021
First posted
Nov 2, 2021
StartActual
Jun 22, 2023
Primary completionEst.
Dec 22, 2026
CompletionEst.
Dec 22, 2026
Last update
Jun 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05103670
Responsible party
Sponsor
First posted
Nov 2, 2021
Start date
Jun 22, 2023
Primary completion
Dec 22, 2026 (estimated)
Completion
Dec 22, 2026 (estimated)
Last update
Jun 16, 2026

Study contacts

Pierre-Yves LE ROUX
Contact
pierre-yves.leroux@chu-brest.fr
+332 98 22 31 17
Pierre-Yves SALAUN
Contact
pierre-yves.salaun@chu-brest.fr
+332 98 22 31 17

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion