Diagnostic Test Accuracy Protocol

MIBG scintigraphy and PET imaging for diagnosing neuroblastoma

  1. Gitta Bleeker1,*,
  2. Godelieve AM Tytgat1,
  3. Judith A Adam2,
  4. Huib N Caron1,
  5. Lotty Hooft3,
  6. Leontien CM Kremer1,
  7. Elvira C van Dalen1

Editorial Group: Cochrane Childhood Cancer Group

Published Online: 7 SEP 2011

DOI: 10.1002/14651858.CD009263

How to Cite

Bleeker G, Tytgat GAM, Adam JA, Caron HN, Hooft L, Kremer LCM, van Dalen EC. MIBG scintigraphy and PET imaging for diagnosing neuroblastoma (Protocol). Cochrane Database of Systematic Reviews 2011, Issue 9. Art. No.: CD009263. DOI: 10.1002/14651858.CD009263.

Author Information

  1. 1

    Emma Children's Hospital / Academic Medical Center, Department of Paediatric Oncology, Amsterdam, Netherlands

  2. 2

    Academic Medical Center, Nuclear Medicine, Amsterdam, Netherlands

  3. 3

    Academic Medical Center, Dutch Cochrane Centre, Amsterdam, Netherlands

*Gitta Bleeker, Department of Paediatric Oncology, Emma Children's Hospital / Academic Medical Center, PO Box 22660, Amsterdam, 1100 DD, Netherlands. g.bleeker@amc.uva.nl.

Publication History

  1. Publication Status: New
  2. Published Online: 7 SEP 2011

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Abstract

  1. Top of page
  2. Abstract

This is the protocol for a review and there is no abstract. The objectives are as follows:

See Figure 1: flowchart of index tests.

 FigureFigure 1. Flow chart index tests in patients with suspected neuroblastoma.

Primary objective 

  1. To determine the diagnostic accuracy of 123I-MIBG (SPECT-CT) scintigraphy for detecting a primary or recurrent neuroblastoma tumour and its metastases in children from 0 to 18 years old.
  2. To determine the diagnostic accuracy of negative 123I-MIBG scintigraphy in combination with 18F-FDG-PET(-CT) imaging for detecting a primary or recurrent neuroblastoma tumour and its metastases in children from 0 to 18 years old. In this case 18F-FDG-PET(-CT) is an add-on test.

Secondary objectives

  1. To determine the diagnostic accuracy of 18F-FDG-PET(-CT) imaging for detecting a primary or recurrent neuroblastoma tumour and its metastases in children from 0 to 18 years old.
  2. To compare the diagnostic accuracy of 123I-MIBG (SPECT-CT) scintigraphy and of 18F-FDG-PET(-CT) imaging for detecting a primary or recurrent neuroblastoma tumour and its metastases in children from 0 to 18 years old. This will be executed within and between (objective 1.1 compared to objective 2.1) included studies. 123I-MIBG (SPECT-CT) scintigraphy is the comparator test in this case.

When assessing study results, we will consider methodological and clinical sources of heterogeneity as well as variation in the criteria used to define a positive test result.

Several factors may contribute to heterogeneity in diagnostic performance across studies. We will investigate, if possible, the potential influence of differences in the following.

Study population:

  • Primary versus recurrent neuroblastoma.
  • Stage of disease (1 to 4 and 4S).

Index test radiolabelled MIBG (SPECT-CT) scintigraphy:

  • Time span between injection and scanning (24 or 48 hours).
  • Whole-body scan versus SPECT-CT.
  • Interfering medication ( Table 3).

Reference standard:

  • Type of test: histopathology (reference test 1) versus bone marrow aspirate or trephine biopsy (reference test 2) versus histopathology in combination with urinary metabolites and additional imaging modalities (reference test 3).