Tracer for the imaging of disease activity in sarcoidosis in the lung

Conditions: Pulmonary sarcoidosis
MedDRA version: 17.0Level: PTClassification code 10037430Term: Pulmonary sarcoidosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2011-003630-13-NL

Lead Sponsor: Sint Antonius Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Men and women > 18 years

Histological proof of sarcoidosis

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 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•A history of hypersensitivity to infliximab
•Treatment with systemic corticosteroids or other immunosuppressive drugs in the year prior to screening
•Previous diagnosis of auto-immune disease
•Pregnancy or nursing
•Mental health problems interfering with participation

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •The main objective is to evaluate the role of 99mTc labelled infliximab in the imaging of disease activity in newly diagnosed sarcoidosis ;Secondary Objective: •To assess the sensitivity of 99mTc labelled infliximab scintigraphy versus 18F-FDG PET to determine sarcoidosis activity in routine sarcoidosis analysis <br>•To study correlations between (semi-quantitative) uptake of 99mTc labelled infliximab and other disease activity markers (serum ACE, serum sIL-2R, chest radiograph, VC, FEV1, DLCO, standardized dyspnea score and 6-minute walk test)<br>;Primary end point(s): Pulmonary uptake of 99mTc labelled infliximab in newly diagnosed sarcoidosis patients v.s. physiological uptake ;Timepoint(s) of evaluation of this end point: Scintigraphy is performed 6 hours and 20 hours after injection with the IMP.

Secondary Outcome Measures