Evaluation of 18F-dopa and 123I-MIBG Uptake in the Patients With Neuroblastoma

• Conditions: Neuroblastoma

• Registration Number: NCT01943097
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2013-09-11
• Study First Submitted QC: 2013-09-11
• Study First Posted: 2013-09-16
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-11
• Last Update Posted: 2014-04-14
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The maximum standardized uptake value and tumor-to-liver uptake ratio	Outcome will be measured in one week after performed.	The maximum standardized uptake value and tumor-to-liver uptake ratio will be evaluated by specific Nuclear Medicine doctor.

Trial Locations

Locations (1)

National Taiwan University Children Hospital; 🇨🇳 Taipei, Taiwan