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

NCT05103670 | Recruiting

• 1 other identifier: 29BRC21.0139 (EOLE)
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Embolism; Dyspnea

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Expressed as a percentage of whole lung

  3 months

Secondary Outcomes (1)

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

  3 months

Study Arms (1)

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.

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

Interventions

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

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

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients planned to be randomized
• Abnormal conventional V/Q scan at V1
• Give consent to participate to the EOLE study

You may not qualify if:

• 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
• Life expectancy of less than 12 months
• Inability to give consent

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

LEROUX Pierre-Yves

Brest, 29200, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism; Dyspnea; Respiratory Aspiration

Interventions

Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Environment, Controlled; Environment; Environment and Public Health

Central Study Contacts

Pierre-Yves LE ROUX

CONTACT

+332 98 22 31 17; pierre-yves.leroux@chu-brest.fr

Pierre-Yves SALAUN

CONTACT

+332 98 22 31 17; pierre-yves.salaun@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 2, 2021
• Study Start: June 22, 2023
• Primary Completion: December 22, 2025
• Study Completion: December 22, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

FR (1)