PheochromocytomaPhase 3NCT00126412
Meta-Iodobenzylguanidine (123I mIBG) Scintigraphy in Patients Being Evaluated for Phaeochromocytoma or Neuroblastoma
A Phase 3 study testing 123I-mIBG (meta-iodobenzylguanidine) in people with Pheochromocytoma and Neuroblastoma, run by GE Healthcare at 1 site in United States.
Trial summary
The study is designed to study the effectiveness of 123I-mIBG as a diagnostic imaging agent in evaluating patients with known or suspected neuroblastoma or phaeochromocytoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pheochromocytoma, Neuroblastoma
- What is being tested?
- 123I-mIBG (meta-iodobenzylguanidine)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2005to 27 Sep 2006
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- For subjects recruited under Amendment 01 :
- a) The subject has known or suspected neuroblastoma and is undergoing evaluation of disease status (for which a 123I-mIBG scintigraphic examination is clinically appropriate) OR b) The subject is ≥18 years of age with either: i) Known phaeochromocytoma. ii) Suspected phaeochromocytoma based on abnormal levels of catecholamines or metabolites in the urine or blood with difficult to control chronic or paroxysmal hypertension and/or abnormalities in the adrenal region on ultrasound, computerised tomography (CT), or magnetic resonance imaging (MRI). iii) A diagnosis of a familial or hereditary condition known to be associated with phaeochromocytoma (multiple endocrine neoplasia, von Hippel-Landau disease, neurofibromatosis, etc).
- For subjects recruited under Amendment 02 :
- a) The subject has known or suspected neuroblastoma and is undergoing evaluation of disease status (for which a 123I-mIBG scintigraphic examination is clinically appropriate) OR b) The subject has either: i) Known phaeochromocytoma, or, ii) Suspected phaeochromocytoma based on abnormal levels of catecholamines or metabolites in the urine or blood in conjunction with difficult to control chronic or paroxysmal hypertension and/or abnormalities in the adrenal region on ultrasound, CT, or MRI, or iii) A diagnosis of a familial or hereditary condition known to be associated with phaeochromocytoma (multiple endocrine neoplasia, von Hippel-Landau disease, neurofibromatosis, etc).
- All subjects: (enrolled under Amendments 01 and 02)
- The subject is able and willing to comply with study procedures and a signed and dated informed consent is obtained.
- The subject was male; or a female who was either pre-menarchal, surgically sterile (had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the results known prior to investigational medicinal product (IMP) administration) was negative.
Who cannot join
- The subject was previously entered into this study or had participated in any other investigational medicinal product or medical device study within 30 days of enrolment.
- The subject had a history or suspicion of significant allergic reaction or anaphylaxis to iodide or iodinated imaging agents.
- The subject presented with any clinically active, serious, life-threatening disease other than neuroblastoma or phaeochromocytoma, with a life expectancy of less than 30 days or where participation in the study would compromise the management of the subject or other reason that in the judgement of the investigator(s) made the subject unsuitable for participation in the study.
- The subject had a history of renal insufficiency (serum creatinine >3.0 mg/dL [265 μmol/L]).
- The subject used medications that are known to interfere with 123I-mIBG uptake and these medications could not be safely withheld for at least 24 hours before study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Multicentre, Phase 3 Scintigraphy Study Assessing 123I-mIBG Uptake in Subjects Being Evaluated for Phaeochromocytoma or Neuroblastoma
The study is designed to study the effectiveness of 123I-mIBG as a diagnostic imaging agent in evaluating patients with known or suspected neuroblastoma or phaeochromocytoma.
- Conditions
- Pheochromocytoma, Neuroblastoma
- Being tested
- 123I-mIBG (meta-iodobenzylguanidine)
- Keywords
- Phaeochromocytoma, Neuroblastoma, diagnosis, 123I-mIBG
- Medical subject headings
- Pheochromocytoma, Neuroblastoma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
123I-mIBG (meta-iodobenzylguanidine)Drug
Also called Iobenguane, mIBG
| Study group | Role | What they receive |
|---|---|---|
| 123I-mIBG (Meta-iobenzylguanidine) | Experimental | All subjects received 123I-mIBG injection over at least 1 to 2 minutes through a cannula (or indwelling catheter in the vein). After the injection of 123I-mIBG was complete, the cannula was flushed with at least 5 mL of 0.9% sodium chloride solution over a maximum of 10 seconds.
All subjects ≥18 years of age and children with a weight of ≥70 kg were to receive an intravenous injection of 370 ±10% MBq (333 to 407 MBq [9.0 to 11 mCi] of 123I-mIBG). Doses of 123I-mIBG for children <18 years of age (with a weight of 8-70 kg) were to be calculated on the basis of a reference activity for an adult scaled to body weight according to the schedule proposed by the European Association of Nuclear Medicine (EANM) Paediatric Task Group; for children <8 kg, a scaled activity or a fixed minimum activity of 80 ±10% MBq (72 to 88 MBq [1.9 to 2.2 mCi]) was permissible. Receives: Drug: 123I-mIBG (meta-iodobenzylguanidine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
- To demonstrate that 123I-mIBG planar scintigraphy is sensitive and specific in confirming or excluding the diagnoses of neuroblastoma and phaeochromocytoma.
Secondary outcomes (2)
To determine the incremental value of single-photon emission computed tomography (SPECT) for improving the sensitivity and specificity of 123I-mIBG planar scintigraphy for the diagnoses of neuroblastoma and phaeochromocytoma.
To collect safety data on 123I-mIBG.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2005 (estimated)
- Study start2 Aug 2005
- Primary completion27 Sep 2006
- Study completion27 Sep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PheochromocytomaStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diane McCaul, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126412
- Sponsor's protocol ID
- MBG308
- Status last verified
- May 2019
- First submitted
- 2 Aug 2005
- Last updated
- 31 May 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicentre, Phase 3 Scintigraphy Study Assessing 123I-mIBG Uptake in Subjects Being Evaluated for Phaeochromocytoma or Neuroblastoma
- ClinicalTrials.gov ID
- NCT00126412
- Acronym / sponsor ID
- MBG308
- Conditions
- Pheochromocytoma, Neuroblastoma
- Keywords
- Phaeochromocytoma, Neuroblastoma, diagnosis, 123I-mIBG
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2005 (actual)
- Primary completion
- 27 Sep 2006 (actual)
- Study completion
- 27 Sep 2006 (actual)
- First posted
- 4 Aug 2005 (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.
The study is designed to study the effectiveness of 123I-mIBG as a diagnostic imaging agent in evaluating patients with known or suspected neuroblastoma or phaeochromocytoma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 123I-mIBG (Meta-iobenzylguanidine) | Experimental | Drug: 123I-mIBG (meta-iodobenzylguanidine)All subjects received 123I-mIBG injection over at least 1 to 2 minutes through a cannula (or indwelling catheter in the vein). After the injection of 123I-mIBG was complete, the cannula was flushed with at least 5 mL of 0.9% sodium chloride solution over a maximum of 10 seconds. All subjects ≥18 years of age and children with a weight of ≥70 kg were to receive an intravenous injection of 370 ±10% MBq (333 to 407 MBq [9.0 to 11 mCi] of 123I-mIBG). Doses of 123I-mIBG for children <18 years of age (with a weight of 8-70 kg) were to be calculated on the basis of a reference activity for an adult scaled to body weight according to the schedule proposed by the European Association of Nuclear Medicine (EANM) Paediatric Task Group; for children <8 kg, a scaled activity or a fixed minimum activity of 80 ±10% MBq (72 to 88 MBq [1.9 to 2.2 mCi]) was permissible. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- a) The subject has known or suspected neuroblastoma and is undergoing evaluation of disease status (for which a 123I-mIBG scintigraphic examination is clinically appropriate) OR b) The subject is ≥18 years of age with either: i) Known phaeochromocytoma. ii) Suspected phaeochromocytoma based on abnormal levels of catecholamines or metabolites in the urine or blood with difficult to control chronic or paroxysmal hypertension and/or abnormalities in the adrenal region on ultrasound, computerised tomography (CT), or magnetic resonance imaging (MRI). iii) A diagnosis of a familial or hereditary condition known to be associated with phaeochromocytoma (multiple endocrine neoplasia, von Hippel-Landau disease, neurofibromatosis, etc).
- a) The subject has known or suspected neuroblastoma and is undergoing evaluation of disease status (for which a 123I-mIBG scintigraphic examination is clinically appropriate) OR b) The subject has either: i) Known phaeochromocytoma, or, ii) Suspected phaeochromocytoma based on abnormal levels of catecholamines or metabolites in the urine or blood in conjunction with difficult to control chronic or paroxysmal hypertension and/or abnormalities in the adrenal region on ultrasound, CT, or MRI, or iii) A diagnosis of a familial or hereditary condition known to be associated with phaeochromocytoma (multiple endocrine neoplasia, von Hippel-Landau disease, neurofibromatosis, etc).
- All subjects: (enrolled under Amendments 01 and 02)
- The subject is able and willing to comply with study procedures and a signed and dated informed consent is obtained.
- The subject was male; or a female who was either pre-menarchal, surgically sterile (had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the results known prior to investigational medicinal product (IMP) administration) was negative.
Key exclusion criteria (5 listed)
- The subject was previously entered into this study or had participated in any other investigational medicinal product or medical device study within 30 days of enrolment.
- The subject had a history or suspicion of significant allergic reaction or anaphylaxis to iodide or iodinated imaging agents.
- The subject presented with any clinically active, serious, life-threatening disease other than neuroblastoma or phaeochromocytoma, with a life expectancy of less than 30 days or where participation in the study would compromise the management of the subject or other reason that in the judgement of the investigator(s) made the subject unsuitable for participation in the study.
- The subject had a history of renal insufficiency (serum creatinine >3.0 mg/dL [265 μmol/L]).
- The subject used medications that are known to interfere with 123I-mIBG uptake and these medications could not be safely withheld for at least 24 hours before study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 123I-mIBG (meta-iodobenzylguanidine)Also: Iobenguane, mIBG | Drug | 123I-mIBG (Meta-iobenzylguanidine) |
Primary outcome
- To demonstrate that 123I-mIBG planar scintigraphy is sensitive and specific in confirming or excluding the diagnoses of neuroblastoma and phaeochromocytoma.
2 secondary outcomes
To determine the incremental value of single-photon emission computed tomography (SPECT) for improving the sensitivity and specificity of 123I-mIBG planar scintigraphy for the diagnoses of neuroblastoma and phaeochromocytoma.
To collect safety data on 123I-mIBG.
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 31 May 2019.
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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.
Diane McCaul study director
GE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 123I-mIBG (meta-iodobenzylguanidine) in people with Pheochromocytoma and Neuroblastoma, run by GE Healthcare at 1 site in United States.
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 7 inclusion and 5 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 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
- To demonstrate that 123I-mIBG planar scintigraphy is sensitive and specific in confirming or excluding the diagnoses of neuroblastoma and phaeochromocytoma.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2019.