Ventilation/Perfusion PET/CT with Galligas and 68Ga-MAA for regional lung function assessment after pulmonary embolism

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Regional Et Universitaire De Brest

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

Decision date (initial)

2025-01-28

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-518293-13-01

EudraCT number

2021-002448-66

ClinicalTrials.gov

NCT05775562

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

To assess the impact of PR on regional perfusion lung function with lung V/Q PET/CT imaging.

Secondary objectives 3

1. To assess the correlation between regional lung function impairment assessed with V/Q PET/CT imaging, and global lung function parameters.
2. To assess the correlation between regional lung function impairment assessed with V/Q PET/CT imaging, and quality of life.
3. To compare the pulmonary vascular obstruction index measured with conventional V/Q scan and V/Q PET/CT imaging.

Conditions and MedDRA coding

Pulmonary embolism

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. -Age ≥ 18 years
2. -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.
3. -Patients who have a PembQol score ≥ 10% and whose total scores for the subgroups Q1 (dyspnea) and Q4 (impact of daily life) are ≥ 10%.
4. -Patients planned to be randomized.
5. -Abnormal conventional V/Q scan at V1
6. -Give consent to participate to the EOLE study.

Exclusion criteria 22

1. - Previsible inability to perform the effort test and/or PR
2. - Presence of CTEPH according to international guidelines
3. - Patients treated for acute PE with anticoagulants for more than 8 months
4. - Active cancer or in remission for less than two years
5. - Dyspnea post – COVID due to parenchymal injuries
6. - Post-COVID hyperventilation syndrome without pulmonary vascular perfusion sequelae
7. - Physical or psychological inability to undertake PR
8. - Isolated or more distal segmental PE
9. - Neuro-muscular disease with PR contraindication.
10. - Cardiac insufficiency (unstable coronary artery disease)
11. - Severe respiratory failure (long-term oxygen therapy, pulmonary hypertension)
12. - Chronic dyspnea MMRC ≥ 2 before PE
13. - Cardiac or respiratory rehabilitation in the previous year
14. - Indication to urgent PR within 6 months at the time of inclusion
15. - Life expectancy of less than 12 months
16. - Inability to give consent
17. - Patient under guardianship or curatorship
18. - Patient deprived of liberty by an administrative or judicial decision
19. - Patient has not social security affiliation or who don’t beneficiary of such social security
20. - Incapacity to perform the effort test
21. - Effort test stopped because of hemodynamic intolerance
22. - Cardiac failure discovered after PR work up

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Pulmonary vascular obstruction index (PVOI), expressed as a percentage of whole lung volume, on V/Q PET/CT imaging.

Secondary endpoints 8

1. V/Q PET/CT regional lung functional volumes : - pulmonary vascular obstruction index
2. V/Q PET/CT regional lung functional volumes : - pulmonary ventilation impairment index
3. Global lung function parameters - Dyspnea scores : MDP, Borg and MMRC
4. Global lung function parameters - Respiratory functional tests (FVC, FEV, FVC-FEV) and TLco
5. Global lung function parameters - Cardio Pulmonary Exercise Tes
6. Global lung function parameters - Cycloergometer endurance tes
7. Global lung function parameters - 6MWT
8. Quality of life - PEmb-QoL score

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Regional Et Universitaire De Brest

Sponsor organisation

Centre Hospitalier Regional Et Universitaire De Brest

Address

2 Avenue Marechal Foch

City

Brest

Postcode

29200

Country

France

Scientific contact point

Organisation

Centre Hospitalier Regional Et Universitaire De Brest

Contact name

Clinical Trial Manager

Public contact point

Organisation

Centre Hospitalier Regional Et Universitaire De Brest

Contact name

Clinical Trial Manager

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications