Expanded Access Protocol for [123I]mIBG for Patients With Known or Suspected Neuroblastoma
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Purpose
GE Healthcare has recently submitted a New Drug Application (NDA) for Iobenguane I 123 Injection ([123I]mIBG (AdreView)) as a diagnostic nuclear imaging agent for the detection of primary or metastatic neuroblastoma and pheochromocytoma. The present protocol establishes an Expanded Access program to provide AdreView to pediatric medical centers and hospitals that treat neuroblastoma patients. AdreView will be provided for use in diagnostic assessment of patients with known or suspected neuroblastoma for whom there is an appropriate clinical indication for [123I]mIBG imaging.
| Condition | Intervention |
|---|---|
|
Neuroblastoma |
Drug: Iobenguane I 123 Injection |
| Study Type: | Expanded Access What is Expanded Access? |
| Official Title: | Expanded Access Protocol for [123I]mIBG for Patients With Known or Suspected Neuroblastoma |
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Drug: Iobenguane I 123 Injection
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.
Eligibility| Genders Eligible for Study: | Both |
Inclusion Criteria:
- The patient has known or suspected neuroblastoma and is undergoing evaluation of disease status (for which a mIBG scintigraphic examination is clinically appropriate).
- 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 procedures.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Arnold F. jacobson, M.D., PhD./Clinical Project Leader, GE Healthcare Ltd. and its affiliates |
| ClinicalTrials.gov Identifier: | NCT00730444 History of Changes |
| Other Study ID Numbers: | GE 122-008 |
| Study First Received: | August 5, 2008 |
| Last Updated: | November 5, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GE Healthcare:
|
Neuroblastoma Nuclear medicine Diagnostic scintigraphy Known and suspected neuroblastoma |
Additional relevant MeSH terms:
|
Neuroblastoma Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue 3-Iodobenzylguanidine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013