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study for evaluation of 18F-choline PET/CT efficacy in patients with prostate carcinoma. - ND

study for evaluation of 18F-choline PET/CT efficacy in patients with prostate carcinoma. - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-021501-20-IT
Enrollment
Unknown
Registered
2010-07-14
Start date
2010-06-22
Completion date
Unknown
Last updated
2012-04-03

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

Conditions

patient with prostate carcinoma MedDRA version: 12.1 Level: LLT Classification code 10036921 Term: Prostate carcinoma

Interventions

Product Name: 18F-choline Pharmaceutical Form: Solution for infusion INN or Proposed INN: tumor detection Concentration unit: MBq/ml megabecquerel(s)/millilitre Concentration type: equal Concentration

Sponsors

ISTITUTO NEUROLOGICO MEDITERRANEO NEUROMED
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: - Histologically proven prostate carcinoma - PSA rising serum levels 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: - Histologically proven prostate carcinoma

Design outcomes

Primary

MeasureTime frame
Main Objective: study for evaluation of 18F-choline PET/CT efficacy in patients with prostate carcinoma regarding to traditional imaging modalities.;Secondary Objective: evaluate perfomance of the exam according to PSA value and histological sample.;Primary end point(s): evaluate 18F-choline efficacy in diagnosis of local relapse regarding to MR; of bone metastases regarding to bone scan; of lymph-nodes metastases regarding to CT—

Countries

Italy

Outcome results

None listed

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