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

Neuroblastoma Clinical Trial

Official title:

The Evaluation of the 6-[18F]Fluoro-levo-dopa and 123I-MIBG Uptake in the Patients With Neuroblastoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01943097
• Other study ID #: 200703053M
• Status: Active, not recruiting
• Phase: N/A
• First received: September 11, 2013
• Last updated: April 11, 2014
• Start date: June 2007
• Est. completion date: December 2014

Study information

• Verified date: April 2014
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Years

Eligibility

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

Observational Model: Case-Crossover, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Neuroblastoma

Locations

Country	Name	City	State
Taiwan	National Taiwan University Children Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximum standardized uptake value and tumor-to-liver uptake ratio	The maximum standardized uptake value and tumor-to-liver uptake ratio will be evaluated by specific Nuclear Medicine doctor.	Outcome will be measured in one week after performed.	No