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

• Register: EUCTR
• Last refreshed on: 20 June 2016
• Main ID: EUCTR2016-000347-14-ES
• Date of registration: 17/05/2016
• Prospective Registration: Yes
• Primary sponsor: IDIBAPS
• Public title: Comparative study between patients with pulmonary hypertension and healthy subjects detecting pulmonary cell changes by FDG PET imaging
• Scientific title: Cell proliferation in pulmonary hypertension: mollecular imaging detection by FDG PET. Comparative study between patients and healthy subjects
• Date of first enrolment: 16/06/2016
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-000347-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Spain

Contacts

• Name: Joan Albert Barberà
• Affiliation: IDIBAPS

• Name: Joan Albert Barberà
• Affiliation: IDIBAPS

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Intervention(s)

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
Concentration unit: MBq megabecquerel(s)
Concentration type: up to
Concentration number: 3000-

Primary Outcome(s)

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 Outcome(s)

Secondary end point(s): Adverse event number
Serious adverse event number

Timepoint(s) of evaluation of this end point: 2 weeks

Secondary ID(s)

PROCLAIM

Source(s) of Monetary Support

ISCIII