Overview

This trial is active, not recruiting.

Condition neuroblastoma
Sponsor National Taiwan University Hospital
Start date June 2007
End date December 2014
Trial size 160 participants
Trial identifier NCT01943097, 200703053M

Summary

Neuroblastic tumors are childhood neoplasms that possess amino acid decarboxylase (AADC) activity and Meta-iodobenzylguanidine(MIBG), they can theoretically be imaged by (18)F-fluorodihydroxyphenylalanine ((18)F-FDOPA) and (123)I-Meta-iodobenzylguanidine((123)I-MIBG) PET, they are new and specific diagnostic and follow-up tools for neuroendocrine tumors. In this study, we explored the accuracy and clinical role of (18)F-FDOPA and (123)I-MIBG PET in neuroblastic tumors.

METHODS:

Patients with tissue-proven neuroblastic tumors receiving (18)F-FDOPA PET or (123)I-MIBG at initial diagnosis or during follow-ups were enrolled. The sensitivity and specificity of (18)F-FDOPA or (123)I-MIBG PET were compared to each other and compared to(18)F-FDG PET, using tumor histology as the standard.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-crossover
Time perspective cross-sectional

Primary Outcomes

Measure
The maximum standardized uptake value and tumor-to-liver uptake ratio
time frame: Outcome will be measured in one week after performed.

Eligibility Criteria

Male or female participants up to 30 years old.

Inclusion Criteria: - (1) Diagnosed by clinical criteria(one of below) 1. Proved as Neuroblastoma by a pathological section 2. Bone meta with 24 hrs urine VMA(Vanillylmandelic acid )or HVA (Homovanillic acid) elevated 3. CT or MRI found tumor around adrenal gland or Neuroblastic tumor - (2) Age between 0-30 years old,Body weight over 2.5kg - (3) Signed Inform Consent Form Exclusion Criteria: - (1)AST and ALT > 200U/L、Cre > 2.5mg/dl - (2)Allerg to 18F-dopa、123I-MIBG - (3)Subject not fit this study(assessed by PI) - (4)No more need to arrenge PET because disease progress, assessed by VS

Additional Information

Official title The Evaluation of the 6-[18F]Fluoro-levo-dopa and 123I-MIBG Uptake in the Patients With Neuroblastoma
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by National Taiwan University Hospital.