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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity Hospital, Brest

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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

    Procedure/Surgery

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

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: Patients undergoing a Ventilation/Perfusion PET/CT at inclusion and 3 months laterExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.