Use of 68Ga-DOTA-NOC for the evaluation of patients with Idiopathic pulmonary fibrosis STUDY CODE: 68Ga-DOTA-NOC/ILD 01/2008 - 68Ga-DOTA-NOC/ILD01/2008

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-007168-40-IT

Enrollment

Registered

2009-03-09

Start date

2009-01-20

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

patients with Idiopathic pulmonary fibrosis MedDRA version: 9.1 Level: LLT Classification code 10021240 Term: Idiopathic pulmonary fibrosis

Interventions

Product Name: Gallium68-Dota-Noc Pharmaceutical Form: Solution for injection Concentration unit: MBq megabecquerel(s) Concentration type: equal Concentration number: 185-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of Idiopathic Pulmonary Fibrosis (IPF, NSIP) 2. Age > 18 3. Informed consent signed 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Breast feeding 3. Healthy volunteers 4. Age <18 5. Patients in emergency state 6. Individuals with reduced approval competence expressing any reluctance to participate to the study as well as those not understanding the purpose of the study 7. Informed consent not signed

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the sensitivity of 68Ga-DOTA-NOC PET/CT for the assessment of Idiopathic Pulmonary Fibrosis patients, in particular IPF and NSIP cases, comparing PET/CT results with data obtained with routinely performed HRCT and pulmonary function tests.;Secondary Objective: Secondary aim is to identify novel therapeutic strategies for these patients. In particular the possibility to visualize somatostain receptor expression in vivo by 68Ga-DOTA-NOC PET/CT allows the selection of patient potentially candidated to receptor targeted therapy.;Primary end point(s): To evaluate the sensitivity of 68Ga-DOTA-NOC PET/CT for the assessment of idiopatic pulmonary fibrosis. Comparison of the extension of fibrosis detected by vs HRCT and prognostic value of SUV compared to HRCT parameter and Pulmonary Function Tests	—

Measure

Time frame

Main Objective: To evaluate the sensitivity of 68Ga-DOTA-NOC PET/CT for the assessment of Idiopathic Pulmonary Fibrosis patients, in particular IPF and NSIP cases, comparing PET/CT results with data obtained with routinely performed HRCT and pulmonary function tests.;Secondary Objective: Secondary aim is to identify novel therapeutic strategies for these patients. In particular the possibility to visualize somatostain receptor expression in vivo by 68Ga-DOTA-NOC PET/CT allows the selection of patient potentially candidated to receptor targeted therapy.;Primary end point(s): To evaluate the sensitivity of 68Ga-DOTA-NOC PET/CT for the assessment of idiopatic pulmonary fibrosis. Comparison of the extension of fibrosis detected by vs HRCT and prognostic value of SUV compared to HRCT parameter and Pulmonary Function Tests

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Countries

Italy

Outcome results

None listed

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