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

99mTc labelled anti-TNF-alpha for the imaging of disease activity in pulmonary sarcoidosis - TISS

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-003630-13-NL
Enrollment
Unknown
Registered
2011-11-07
Start date
2011-11-22
Completion date
Unknown
Last updated
2014-07-14

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

Conditions

Pulmonary sarcoidosis MedDRA version: 17.0 Level: PT Classification code 10037430 Term: Pulmonary sarcoidosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

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 co

Sponsors

Sint Antonius Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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 • 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) ;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

MeasureTime frame
Secondary end point(s): none.;Timepoint(s) of evaluation of this end point: not applicable—

Countries

Netherlands

Contacts

Public ContactRoeland Vis

St Antonius Hospital

r.vis@antoniusziekenhuis.nl0031306092612

Outcome results

None listed

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