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

NCT ID: NCT01943097

Last Updated: 2014-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Neuroblastoma

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Children Hospital

Taipei, Taiwan, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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200703053M

Identifier Type: -

Identifier Source: org_study_id

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