NeuroblastomaNCT00590096
I-123-MIBG for Imaging of Neuroblastoma and Pheochromocytoma
An observational study of Neuroblastoma and Pheochromocytoma, run by Children's Hospital Medical Center, Cincinnati.
Trial summary
I-123-MIBG is used to image patients with neuroblastoma, pheochromocytoma and other neural crest tumors Read more about this study
- Who is it for?
- Ages 2 weeks and older
- Conditions the study is for
- Neuroblastoma, Pheochromocytoma
- How many people
- 1,380 participants
- Where
- No sites listed yet
- Study dates
- Jan 1991to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with histologically proven neuroblastoma or pheochromocytoma or strong suspicion of neuroblastoma or pheochromocytoma
Who may be able to join
- Histologically proven neuroblastoma or pheochromocytoma or strong suspicion of neuroblastoma or pheochromocytoma
Who cannot join
- Pregnancy
About this study
I-123-MIBG is used to image patients with neuroblastoma, pheochromocytoma and other neural crest tumors
Read the detailed description
Entry criteria--Histologically documented neuroblastoma or pheochromocytoma or strong suspicion of neuroblastoma or pheochromocytoma.
Exclusion criteria--Pregnancy Randomization--None Procedure--Patients will receive a dose of I-123-MIBG by intravenous injection. Images will obtained at 18-24 hours after administration of the drug and at 42-48 hours as needed. SSKI will be used to block thyroid uptake of free I-123-iodide
- Conditions
- Neuroblastoma, Pheochromocytoma
- Keywords
- Neuroblastoma, Pheochromocytoma, MIBG
- Medical subject headings
- Neuroblastoma, Pheochromocytoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startJan 1991
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Enrolment
- 1,380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cincinnati
- Investigators
- Michael J Gelfand, M.D., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590096
- Sponsor's protocol ID
- CCHMC# 88-12-2
- Status last verified
- Jan 2007
- First submitted
- 27 Dec 2007
- Last updated
- 25 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Chan EL, Harris RE, Emery KH, Gelfand MJ, Collins MH, Gruppo RA. Favorable histology, MYCN-amplified 4S neonatal neuroblastoma. Pediatr Blood Cancer. 2007 Apr;48(4):479-82. doi: 10.1002/pbc.20705.
PubMed 16333837Gelfand MJ. 123I-MIBG uptake in the neck and shoulders of a neuroblastoma patient: damage to sympathetic innervation blocks uptake in brown adipose tissue. Pediatr Radiol. 2004 Jul;34(7):577-9. doi: 10.1007/s00247-003-1136-x. Epub 2004 Mar 3.
PubMed 15205842Gelfand MJ. Meta-iodobenzylguanidine in children. Semin Nucl Med. 1993 Jul;23(3):231-42. doi: 10.1016/s0001-2998(05)80104-7.
PubMed 8378796Gelfand MJ, Elgazzar AH, Kriss VM, Masters PR, Golsch GJ. Iodine-123-MIBG SPECT versus planar imaging in children with neural crest tumors. J Nucl Med. 1994 Nov;35(11):1753-7.
PubMed 7965151Paltiel HJ, Gelfand MJ, Elgazzar AH, Washburn LC, Harris RE, Masters PR, Golsch GJ. Neural crest tumors: I-123 MIBG imaging in children. Radiology. 1994 Jan;190(1):117-21. doi: 10.1148/radiology.190.1.8259387.
PubMed 8259387Englaro EE, Gelfand MJ, Harris RE, Smith HS. I-131 MIBG imaging after bone marrow transplantation for neuroblastoma. Radiology. 1992 Feb;182(2):515-20. doi: 10.1148/radiology.182.2.1732972.
PubMed 1732972Elgazzar AH, Gelfand MJ, Washburn LC, Clark J, Nagaraj N, Cummings D, Hughes J, Maxon HR 3rd. I-123 MIBG scintigraphy in adults. A report of clinical experience. Clin Nucl Med. 1995 Feb;20(2):147-52. doi: 10.1097/00003072-199502000-00011.
PubMed 7720307
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-123-MIBG for Imaging of Neuroblastoma and Pheochromocytoma
- ClinicalTrials.gov ID
- NCT00590096
- Acronym / sponsor ID
- CCHMC# 88-12-2
- Conditions
- Neuroblastoma, Pheochromocytoma
- Keywords
- Neuroblastoma, Pheochromocytoma, MIBG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,380 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- University of Cincinnati
- Study start
- Jan 1991
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 10 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
I-123-MIBG is used to image patients with neuroblastoma, pheochromocytoma and other neural crest tumors
Detailed description
Entry criteria--Histologically documented neuroblastoma or pheochromocytoma or strong suspicion of neuroblastoma or pheochromocytoma.
Exclusion criteria--Pregnancy Randomization--None Procedure--Patients will receive a dose of I-123-MIBG by intravenous injection. Images will obtained at 18-24 hours after administration of the drug and at 42-48 hours as needed. SSKI will be used to block thyroid uptake of free I-123-iodide
Study design
- Observational model
- Case only
Who may qualify
- Ages
- 2 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with histologically proven neuroblastoma or pheochromocytoma or strong suspicion of neuroblastoma or pheochromocytoma
Key inclusion criteria (1 listed)
- Histologically proven neuroblastoma or pheochromocytoma or strong suspicion of neuroblastoma or pheochromocytoma
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2009.
- Background: PubMed 16333837Chan EL, Harris RE, Emery KH, Gelfand MJ, Collins MH, Gruppo RA. Favorable histology, MYCN-amplified 4S neonatal neuroblastoma. Pediatr Blood Cancer. 2007 Apr;48(4):479-82. doi: 10.1002/pbc.20705.
- Background: PubMed 15205842Gelfand MJ. 123I-MIBG uptake in the neck and shoulders of a neuroblastoma patient: damage to sympathetic innervation blocks uptake in brown adipose tissue. Pediatr Radiol. 2004 Jul;34(7):577-9. doi: 10.1007/s00247-003-1136-x. Epub 2004 Mar 3.
- Background: PubMed 8378796Gelfand MJ. Meta-iodobenzylguanidine in children. Semin Nucl Med. 1993 Jul;23(3):231-42. doi: 10.1016/s0001-2998(05)80104-7.
- Results publication: PubMed 7965151Gelfand MJ, Elgazzar AH, Kriss VM, Masters PR, Golsch GJ. Iodine-123-MIBG SPECT versus planar imaging in children with neural crest tumors. J Nucl Med. 1994 Nov;35(11):1753-7.
- Results publication: PubMed 8259387Paltiel HJ, Gelfand MJ, Elgazzar AH, Washburn LC, Harris RE, Masters PR, Golsch GJ. Neural crest tumors: I-123 MIBG imaging in children. Radiology. 1994 Jan;190(1):117-21. doi: 10.1148/radiology.190.1.8259387.
- Results publication: PubMed 1732972Englaro EE, Gelfand MJ, Harris RE, Smith HS. I-131 MIBG imaging after bone marrow transplantation for neuroblastoma. Radiology. 1992 Feb;182(2):515-20. doi: 10.1148/radiology.182.2.1732972.
- Results publication: PubMed 7720307Elgazzar AH, Gelfand MJ, Washburn LC, Clark J, Nagaraj N, Cummings D, Hughes J, Maxon HR 3rd. I-123 MIBG scintigraphy in adults. A report of clinical experience. Clin Nucl Med. 1995 Feb;20(2):147-52. doi: 10.1097/00003072-199502000-00011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Gelfand, M.D. principal investigator
Children's Hospital Medical Center, Cincinnati
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroblastoma and Pheochromocytoma, run by Children's Hospital Medical Center, Cincinnati.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00590096, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2009.