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Expanded Access Protocol for [123I]mIBG for Patients With Known or Suspected Neuroblastoma

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Trial Information

Expanded Access Protocol for [123I]mIBG for Patients With Known or Suspected Neuroblastoma

The sponsor will provide [123I]mIBG as a single dose in a ready-to-use vial. All patients
greater than or equal to 18 years of age and children with a weight of greater than or equal
to 70 kg will receive an intravenous injection of 370 ±10% MBq (333 to 407 MBq [9.0 to 11
mCi]) of [123I]mIBG. Children <16 years of age (with a weight of 8-70 kg) will receive an
activity of [123I]mIBG calculated on the basis of a reference activity for an adult scaled
to body weight. Each investigator is responsible for obtaining the appropriate thyroid
blockade agent and for its administration in accordance with national and local regulations
and guidelines. Approximately 24 (± 6) hours following administration of [123I]mIBG all
patients will return to the clinic for scintigraphic imaging. Imaging will be performed as
per the standard procedures of the investigational site. This should include at a minimum
total body planar scintigraphy. Single photon emission computed tomography (SPECT) may be
performed following planar scintigraphy, as appropriate.

Inclusion Criteria:

- The patient has known or suspected neuroblastoma and is undergoing evaluation of
disease status (for which a mIBG scintigraphic examination is clinically

- The patient is able and willing to comply with study procedures and a signed and
dated informed consent is obtained from the patient (or their legal guardian.

Exclusion Criteria:

- The patient uses medications that are known to interfere with [123I]mIBG uptake and
these medications cannot be safely withheld for a least 24 hours before study

Type of Study:

Expanded Access

Study Design:


Principal Investigator

Arnold Jacobson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

GE Healthcare


United States: Food and Drug Administration

Study ID:

GE 122-008



Start Date:

Completion Date:

Related Keywords:

  • Neuroblastoma
  • Neuroblastoma
  • Nuclear medicine
  • Diagnostic scintigraphy
  • Known and suspected neuroblastoma
  • Neuroblastoma



GE Healthcare Princeton, New Jersey  08540