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

Primary Purpose

Pulmonary Embolism, Dyspnea

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

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

About this trial

This is an interventional basic science trial for Pulmonary Embolism focused on measuring Ventilation/perfusion PET/CT, Galligas, 68Ga-MAA

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

LEROUX Pierre-YvesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients undergoing a Ventilation/Perfusion PET/CT at inclusion and 3 months later

Arm 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 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.

Outcomes

Primary Outcome Measures

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

Expressed as a percentage of whole lung

Secondary Outcome Measures

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

Expressed as a percentage of whole lung

Full Information

NCT ID

NCT05103670

First Posted

October 21, 2021

Last Updated

July 28, 2023

Sponsor

University Hospital, Brest

1. Study Identification

Unique Protocol Identification Number

NCT05103670

Brief Title

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

Acronym

EOLE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 22, 2023 (Actual)

Primary Completion Date

December 22, 2025 (Anticipated)

Study Completion Date

December 22, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Embolism, Dyspnea

Keywords

Ventilation/perfusion PET/CT, Galligas, 68Ga-MAA

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients undergoing a Ventilation/Perfusion PET/CT at inclusion and 3 months later

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

32 patients will undergo a Ventilation/Perfusion PET/CT with Galligas and 68Ga-MAA at the inclusion and 3 months later.

Primary Outcome Measure Information:

Title

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

Description

Expressed as a percentage of whole lung

Time Frame

3 months

Secondary Outcome Measure Information:

Title

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

Description

Expressed as a percentage of whole lung

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pierre-Yves LE ROUX

Phone

+332 98 22 31 17

pierre-yves.leroux@chu-brest.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Pierre-Yves SALAUN

Phone

+332 98 22 31 17

pierre-yves.salaun@chu-brest.fr

Facility Information:

Facility Name

LEROUX Pierre-Yves

City

Brest

ZIP/Postal Code

29200

Country

France

Individual Site Status

Recruiting

Facility Contact: