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

April 11, 2014 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Children Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients With Neuroblastoma

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

September 11, 2013

First Submitted That Met QC Criteria

September 11, 2013

First Posted (Estimate)

September 16, 2013

Study Record Updates

Last Update Posted (Estimate)

April 14, 2014

Last Update Submitted That Met QC Criteria

April 11, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200703053M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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