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

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005398-30-IT

Enrollment

Registered

2013-01-11

Start date

2013-05-03

Completion date

Unknown

Last updated

2018-02-26

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

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: 14.1 Level: PT Classification code 10029260 Term: Neuroblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: isodopa Pharmaceutical Form: Concentrate for solution for injection Other descriptive name: 6-[18F]fluoro-L-dopa Concentration unit: MBq/kg megabecquerel(s)/kilogram Concentration type: up

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age > 12 months =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Italy

Contacts

Public Contacts.c. medicina nucleare

e.o. ospedali galliera

arnoldo.piccardo@galliera.it0105634541

Outcome results

None listed

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