Comparative study between patients with pulmonary hypertension and healthy subjects detecting pulmonary cell changes by FDG PET imaging

Cell proliferation in pulmonary hypertension: mollecular imaging detection by FDG PET. Comparative study between patients and healthy subjects

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000347-14-ES

Enrollment

Unknown

Registered

2016-05-17

Start date

2016-06-16

Completion date

Unknown

Last updated

2016-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary artery hypertension and thromboembolic chronic pulmonary hypertension MedDRA version: 19.0 Level: LLT Classification code 10037405 Term: Pulmonary hypertension primary System Organ Class: 100000004855 MedDRA version: 19.0 Level: LLT Classification code 10068739 Term: Chronic thromboembolic pulmonary hypertension System Organ Class: 100000004855

Interventions

Trade Name: Barnascan Product Name: BARNASCAN Pharmaceutical Form: Solution for injection INN or Proposed INN: FLUDEOXYGLUCOSE CAS Number: 105851-17-0 Other descriptive name: FLUDEOXYGLUCOSE Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male and female Age 18-75 Patients with precapillary pulmonary hypertension Healthy subjects with normal lung function Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: Severe comorbidities. ? Lung disease or condition interfering with FDG-PET image acquisition ? Active cancer except basocellular skin carcinoma ? Current smokers - Pregnancy or breastfeeding Hyperglycaemia (above 200 mg/dL) - Hypersensitivity to FDG or excipients.

Design outcomes

Primary

Measure	Time frame
Main Objective: to identify cell proliferation processes in patients with severe forms of pulmonary hypertension;Secondary Objective: Safety of FDG PET miRNA study cell line characterization;Primary end point(s): FDG uptake per volume unit (standardized uptake valueSUV);Timepoint(s) of evaluation of this end point: 60 min	—

Secondary

Measure	Time frame
Secondary end point(s): Adverse event number Serious adverse event number;Timepoint(s) of evaluation of this end point: 2 weeks	—

Countries

Spain

Contacts

Public ContactJoan Albert Barberà

IDIBAPS

jbarbera@clinic.cat34932275400

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026