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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 14 July 2014
Main ID:  EUCTR2011-003630-13-NL
Date of registration: 07/11/2011
Prospective Registration: Yes
Primary sponsor: Sint Antonius Hospital
Public title: Tracer for the imaging of disease activity in sarcoidosis in the lung
Scientific title: 99mTc labelled anti-TNF-alpha for the imaging of disease activity in pulmonary sarcoidosis - TISS
Date of first enrolment: 22/11/2011
Target sample size:
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003630-13
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: no 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  
Phase: 
Countries of recruitment
Netherlands
Contacts
Name: Roeland Vis   
Address:  Koekoekslaan 1 3430 EM Nieuwegein Netherlands
Telephone: 0031306092612
Email: r.vis@antoniusziekenhuis.nl
Affiliation:  St Antonius Hospital
Name: Roeland Vis   
Address:  Koekoekslaan 1 3430 EM Nieuwegein Netherlands
Telephone: 0031306092612
Email: r.vis@antoniusziekenhuis.nl
Affiliation:  St Antonius Hospital
Key inclusion & exclusion criteria
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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Pulmonary sarcoidosis
MedDRA version: 17.0 Level: PT Classification code 10037430 Term: Pulmonary sarcoidosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Intervention(s)

Product Name: 99mTc-Infliximab
Product Code: not applicable
Pharmaceutical Form: Radiopharmaceutical precursor, solution
INN or Proposed INN: not applicable
CAS Number: not applicab
Current Sponsor code: not applicable
Other descriptive name: 99m technetium infliximab
Concentration unit: MBq megabecquerel(s)
Concentration type: equal
Concentration number: 370 -

Primary Outcome(s)
Main Objective: • The main objective is to evaluate the role of 99mTc labelled infliximab in the imaging of disease activity in newly diagnosed sarcoidosis
Primary end point(s): Pulmonary uptake of 99mTc labelled infliximab in newly diagnosed sarcoidosis patients v.s. physiological uptake
Secondary Objective: • To assess the sensitivity of 99mTc labelled infliximab scintigraphy versus 18F-FDG PET to determine sarcoidosis activity in routine sarcoidosis analysis
• 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)
Timepoint(s) of evaluation of this end point: Scintigraphy is performed 6 hours and 20 hours after injection with the IMP.
Secondary Outcome(s)
Secondary end point(s): none.
Timepoint(s) of evaluation of this end point: not applicable
Secondary ID(s)
2091919
Source(s) of Monetary Support
Sint Antonius Hospital
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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