Evaluation of the role of 18F-di-idrossi-fenil-alanina 18F-DOPA in images diagnostic by Positron Emission Tomography PET in study of human neuroendocrin neoplasia. - ND

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-006209-16-IT

Enrollment

100

Registered

2006-05-09

Start date

2006-03-06

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Neuroendocrin neoplasie carcinoid, thyroid medullary carcinoma, neuroendocrin neoplasie, feocromocitoma, melanoma and neuroblastoma . MedDRA version: 6.1 Level: HLT Classification code 10014714

Interventions

Product Name: F-DOPA Pharmaceutical Form: Solution for injection Other descriptive name: F-diidroxy-fenil-alanine Concentration unit: MBq megabecquerel(s) Concentration type: equal Concentration numbe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult subjects age 18 years of both sex, carriers of neuroendocrin neoplasie. Patients in pediatric age affections from neuroblastoma Are the trial subjects under 18? yes 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: - subject unsound of mind; - age 18 years; - women in pregnancy; - women in breast-feeding; - patients in emergency situation.

Design outcomes

Primary

Measure	Time frame
Main Objective: - to allow earlier diagnosis of the neural crest derivation neoplasie; - more accurate evaluation of primitive neoplasia extension, of eventual secondary lesions presence and of the therapy answer; - identification of the primitive seat of disease in presence of secondary neoplastic lesion of unknown origin.;Secondary Objective: To set up a personalized therapeutic program for every patient in order to reduce the charitable costs.;Primary end point(s): To verify the additional role of the PET with F-dopa in the diagnosis, phase assesment and evaluation of the therapy answer, in patients with neuroendocrin derivation neoplasie regarding the other techniques of images diagnostic currently used.	—

Measure

Time frame

Main Objective: - to allow earlier diagnosis of the neural crest derivation neoplasie; - more accurate evaluation of primitive neoplasia extension, of eventual secondary lesions presence and of the therapy answer; - identification of the primitive seat of disease in presence of secondary neoplastic lesion of unknown origin.;Secondary Objective: To set up a personalized therapeutic program for every patient in order to reduce the charitable costs.;Primary end point(s): To verify the additional role of the PET with F-dopa in the diagnosis, phase assesment and evaluation of the therapy answer, in patients with neuroendocrin derivation neoplasie regarding the other techniques of images diagnostic currently used.

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Countries

Italy

Outcome results

None listed

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