Diagnostic efficacy and prognostic method [18F] DOPA-PET/CT instudy of neuroblastoma: comparison with 123I-MIBG scintigraphy

Phase 1

Conditions: patients wiht NB onset with high probability to return in stages 3 and 4 of the disease on the basis of the ultrasound images or TC. May also be included with the two-stage amplification of N-MYC
MedDRA version: 14.1Level: PTClassification code 10029260Term: NeuroblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-005398-30-IT

Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALI GALLIERA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 40

Inclusion Criteria

- Age > 12 months <18 years
- Patients suffering from NB onset with high probability to return in stages 3 and 4 of the disease on the basis of
ultrasound or CT images. May also be included with the two-stage amplification of N-MYC
- Histological diagnosis of NB
- No previous chemotherapy lines with the exception of steroid treatment
- written informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Comorbidity for other cancers
- Hypersensitivity to the active substance or excipients in the radiopharmaceutical.
- Any other medical condition at the discretion of the investigator.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: check the diagnostic accuracy of 18F-DOPA-PET/TC compared with scintigraphy with 123I-MIBG during the staging of disease in patients with NB;Secondary Objective: 18F-DOPA-PET/TC verify the non-inferiority compared to 123I-MIBG scintigraphy in predicting prognosis and evaluation of response to therapy and in predicting prognosis;Primary end point(s): check the diagnostic accuracy of 18F-DOPA-PET/TC compared with scintigraphy with 123I-MIBG during the staging of disease in patients with NB;Timepoint(s) of evaluation of this end point: 48 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 18F-DOPA-PET/TC verify the non-inferiority compared to 123I-MIBG scintigraphy in predicting prognosis and evaluation of response to therapy and in predicting prognosis;Timepoint(s) of evaluation of this end point: 48 months