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PHASE II CLINICAL STUDY OF THE DIAGNOSTIC EFFICACY OF [18F]FLUOROETHYILCHOLINE ([18F]FECh) IN PATIENTS WITH PROSTATE CANCER - ND

PHASE II CLINICAL STUDY OF THE DIAGNOSTIC EFFICACY OF [18F]FLUOROETHYILCHOLINE ([18F]FECh) IN PATIENTS WITH PROSTATE CANCER - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-008301-22-IT
Enrollment
Unknown
Registered
2009-01-22
Start date
2010-03-05
Completion date
Unknown
Last updated
2013-01-07

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

Conditions

PROSTATE CANCER MedDRA version: 9.1 Level: HLT Classification code 10036908 Term: Prostatic neoplasms malignant

Interventions

Product Name: [18F] Fluoroetilcolina Pharmaceutical Form: Solution for injection Concentration unit: MBq megabecquerel(s) Concentration type: equal Concentration number: 222-

Sponsors

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: - adult male patients with a) known prostate cancer (biopsy) and eligible for surgical treatment; b) biochemical recurrence of prostate cancer after prostatectomy (PSA> 0.2 ng/ml) - availability to participate to the study (informed consent); - patients suitable for the diagnostic procedure (PET-TC with 18F-FECh); - patients with life expectancy > 2 months. 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: - patients not suitable for the study protocol; - patients with life expectancy < 2 months

Design outcomes

Primary

MeasureTime frame
Main Objective: 1. to evaluate the diagnostic efficacy ?in terms of sensitivity, specificity and accuracy- of PET-TC with [18F]Fluoroethyilcholine ([18F]FECh) in: a. patients with known prostate cancer, in whom 18F]FECh PET-TC is performed to evaluate loco-regional or distant disease extension (staging); b. patients previously treated for prostate cancer who present at follow-up elevated PSA levels, in whom 18F]FECh PET-TC is performed to localize the neoplastic lesions; 2. to evaluate the additional role of PET-TC with [18F]FECh with respect to the other diagnostic imaging techniques that are routinely used such as ultrasonography with trans-rectal probe, computed tomography (CT), magnetic resonance (MR) and bone scintigraphy.;Secondary Objective: is to perform dosimetric evaluation of [18F]FECh in a group of patients with prostate cancer.;Primary end point(s): nd—

Countries

Italy

Outcome results

None listed

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