NeuroblastomaEarly Phase 1NCT01583842
124I-Metaiodobenzylguanidine (MIBG) PET/CT Diagnostic Imaging and Dosimetry for Patients With Neuroblastoma: A Pilot Study
A Early Phase 1 study testing 124I-Metaiodobenzylguanidine (MIBG) (no-carrier added), 124I-MIBG (carrier added) and Positron Emission Tomography (PET) /Computerized tomography (CT) in people with Neuroblastoma, run by Miguel Pampaloni at 1 site in United States.
Trial summary
This is a pilot study with the primary purpose to describe organ dosimetry and acute toxicities using no carrier added and carrier added 124I-MIBG PET/CT in patients with neuroblastoma (NB). Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- 124I-Metaiodobenzylguanidine (MIBG) (no-carrier added), 124I-MIBG (carrier added) and Positron Emission Tomography (PET) /Computerized tomography (CT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2013to 25 Feb 2021
- Phase
- Early Phase 1
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must be >/= 3 years of age and able to cooperate for the PET CT scan when registered on study.
- Patients must have a diagnosis of neuroblastoma either by histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamine metabolites.
- Recurrent/progressive disease at any time. Biopsy is not required, even if there is a partial response to intervening therapy or
- Refractory disease (i.e. less than a partial response to frontline therapy, including a minimum of 4 cycles of chemotherapy). No biopsy is required for eligibility for this study.
- 123I-MIBG Uptake: Patients must have MIBG evaluable disease which is defined as evidence of uptake into tumor at one site within 4 weeks prior to entry on study and subsequent to any intervening therapy.
- Patients must meet eligibility criteria for 131I-MIBG therapy in order to participate in the dosimetry portion.
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- All post-menarchal females must have a negative beta-Human Chorionic Gonadotropin (hCG) within 2 weeks prior to receiving the dose of 124I-MIBG. Males and females of childbearing potential must practice an effective method of birth control while participating on this study, to avoid possible damage to the fetus.
- Imaging only cohort:
- Patients with high-risk neuroblastoma are eligible at any time (during initial treatment or during treatment of relapsed/refractory disease) as long as they meet the requirements.
Who cannot join
- Pregnancy or lactating with the intent of breast feeding.
- Patients who require general anesthesia for MIBG imaging studies.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
This is a pilot study with the primary purpose to describe organ dosimetry and acute toxicities using no carrier added and carrier added 124I-MIBG PET/CT in patients with neuroblastoma (NB). Eligible patients are 3 years of age and older with relapsed or refractory neuroblastoma who are currently enrolled on a treatment protocol with 131I-MIBG. After all eligibility criteria are met, patients will receive a diagnostic imaging dose of 124I-MIBG followed by sequential PET/CT dosimetry scans on Days 0, 1, 2 and 5. Subsequent, planned therapeutic administration of 131I-MIBG will occur between Days 7 to 21, as specified by the patient's therapeutic MIBG protocol. An optional single follow up 124I-MIBG PET-CT scan will be done to assess tumor sites 6 weeks after the patient has their MIBG therapy.
Read the detailed description
Accurate radiation dose evaluation is important in patients with malignant tumors, and this is especially critical in children with NB who will be receiving several dose of therapeutic 131I. The accurate quantification of the isotope-labeled analog can only be achieved by using positron emission compounds, such as 124I. Unlike planar images, which were used to obtain kinetic information, and SPECT reconstruction modalities that were aimed to assess the spatial distribution of radioactivity, 3D PET imaging-based dosimetry is a method which provides a more accurate estimation of the cumulated radioactivity distribution. Because PET provides better quantitative accuracy, when compared to SPECT regarding the tissue absorbed information, we hypothesize PET would better correspond with tumor response and normal organ toxicity. Early studies using I-124 for dosimetry in thyroid cancer have been promising.
Demonstration of the feasibility and accuracy of this new imaging modality, with the excellent prospect for more accurate dosimetry, will improve tumor localization and optimize therapeutic dosing with 131I-MIBG. The results of our work may potentially have also implications in the study of other neuroendocrine tumors. The Section of Nuclear Medicine and the Laboratory of Functional Imaging at the University of California, San Francisco, are equipped with state of the art instruments and is run by a highly skilled staff which will guarantee the success of the proposed research.
- Conditions
- Neuroblastoma
- Being tested
- 124I-Metaiodobenzylguanidine (MIBG) (no-carrier added), 124I-MIBG (carrier added), Positron Emission Tomography (PET) /Computerized tomography (CT)
- Keywords
- neuroblastoma, imaging, 124I-MIBG, 131I-MIBG, PET/CT
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
124I-Metaiodobenzylguanidine (MIBG) (no-carrier added)Drug
Also called 124I MIBG, MIBG
124I-MIBG (no-carrier added) Administration (infusion, 1-2 minutes) followed by sequential PET/CT dosimetry scans on Days 0, 1, 2 and 5.
Optional 124I-MIBG (no-carrier added) Administration \& PET/CT scan 6 weeks later.
124I-MIBG (carrier added)Drug
Also called 124I MIBG, MIBG
124I-MIBG (carrier added) Administration (infusion, 60 minutes) followed by sequential PET/CT dosimetry scans on Days 0, 1, 2 and 5.
Optional 124I-MIBG (carrier added) Administration \& PET/CT scan 6 weeks later.
Positron Emission Tomography (PET) /Computerized tomography (CT)Procedure or surgery
Also called PET/CT
A PET scan measures important body functions, such as metabolism. CT imaging uses special x-ray equipment, and in some cases a contrast material, to produce multiple images of the inside of the body. Combined PET/CT scans combine the processes of both a PET and CT at the same time.
| Study group | Role | What they receive |
|---|---|---|
| 124I-MIBG no-carrier added | Experimental | Patients are 3 years of age and older with relapsed or refractory neuroblastoma who are currently enrolled on a treatment protocol with 131I-MIBG. Receives: Drug: 124I-Metaiodobenzylguanidine (MIBG) (no-carrier added); Procedure: Positron Emission Tomography (PET) /Computerized tomography (CT) |
| 124I-MIBG carrier added | Experimental | Patients are 3 years of age and older with relapsed or refractory neuroblastoma who are currently enrolled on a treatment protocol with 131I-MIBG. Receives: Drug: 124I-MIBG (carrier added); Procedure: Positron Emission Tomography (PET) /Computerized tomography (CT) |
| Imaging Only | Active comparator | Participants with high-risk neuroblastoma will receive imaging only without 124I-MIBG Receives: Procedure: Positron Emission Tomography (PET) /Computerized tomography (CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements of organ dosimetry using high specific activity (no carrier added)
Descriptive statistics for each organ dose obtained from the organ dosimetry data will be reported, to demonstrate organ dosimetry calculations are feasible and concordant with prior calculations in prior conjugate planar dosimetry imaging studies and our pre-clinical murine models
Measured: Up to 7 weeks
Measurements of organ dosimetry using low specific activity (carrier added)
Descriptive statistics for each organ dose obtained from the organ dosimetry data will be reported, to demonstrate organ dosimetry calculations are feasible and concordant with prior calculations in prior conjugate planar dosimetry imaging studies and our pre-clinical murine models
Measured: Up to 7 weeks
Number of participants with grade 3 or 4 imaging-related toxicities.
All patients will have toxicity monitoring for 6 weeks following 124I-MIBG administration. Toxicities will be graded according to the NCI Common Toxicity Criteria for Adverse Events (CTCAEv4.0)and attribution assigned.
Measured: Up to 7 weeks
Change from baseline of blood pressure
Blood pressure will be recorded before, during, end injection and post-injection at baseline, days 1, 2 and 5 and again at week 7 if participants choose to have optional week 7 scan
Measured: Up to 7 weeks
Change from baseline of pulse measurements
Participants pulse will be recorded before, during, end injection and post-injection at baseline, days 1, 2 and 5 and again at week 7 if participants choose to have optional week 7 scan
Measured: Up to 7 weeks
Secondary outcomes (3)
Measurements of tumor dosimetry using low specific activity (carrier added)
Descriptive statistics will be used to report the tumor dosimetry data
Measured: Up to 7 weeks
Measurements of tumor dosimetry using high specific activity (no carrier added)
Descriptive statistics will be used to report the tumor dosimetry data
Measured: Up to 7 weeks
Assessment of the accuracy of tumor imaging
Descriptive statistics will be used to report the tumor dosimetry data compared to using 123I-MIBG scan with 3-dimensional imaging by SPECT or SPECT/CT
Measured: Up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study start9 Apr 2013
- Primary completion25 Feb 2021
- Study completion25 Feb 2021
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miguel Pampaloni
- Sponsor type
- University, hospital or other
- Collaborators
- Molecular Insight Pharmaceuticals, Inc., Jubilant DraxImage Inc.
- Responsible party
- Sponsor-investigator, Miguel Pampaloni, University of California, San Francisco
- Investigators
- Katherine Matthay, MD, Principal investigator, University of California, San FranciscoJose Miguel Hernandez-Pampaloni, MD, PhD, Principal investigator, University of California, San FranciscoYoungho Seo, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583842
- Sponsor's protocol ID
- 12088
- Other IDs
- NCI-2012-00617
- Status last verified
- May 2021
- First submitted
- 17 Apr 2012
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 124I-Metaiodobenzylguanidine (MIBG) PET/CT Diagnostic Imaging and Dosimetry for Patients With Neuroblastoma: A Pilot Study
- ClinicalTrials.gov ID
- NCT01583842
- Acronym / sponsor ID
- 12088
- Conditions
- Neuroblastoma
- Keywords
- neuroblastoma, imaging, 124I-MIBG, 131I-MIBG, PET/CT
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Miguel PampaloniUniversity, hospital or other
- Collaborators
- Molecular Insight Pharmaceuticals, Inc., Jubilant DraxImage Inc.
- Study start
- 9 Apr 2013 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 24 Apr 2012 (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.
This is a pilot study with the primary purpose to describe organ dosimetry and acute toxicities using no carrier added and carrier added 124I-MIBG PET/CT in patients with neuroblastoma (NB). Eligible patients are 3 years of age and older with relapsed or refractory neuroblastoma who are currently enrolled on a treatment protocol with 131I-MIBG. After all eligibility criteria are met, patients will receive a diagnostic imaging dose of 124I-MIBG followed by sequential PET/CT dosimetry scans on Days 0, 1, 2 and 5. Subsequent, planned therapeutic administration of 131I-MIBG will occur between Days 7 to 21, as specified by the patient's therapeutic MIBG protocol. An optional single follow up 124I-MIBG PET-CT scan will be done to assess tumor sites 6 weeks after the patient has their MIBG therapy.
Detailed description
Accurate radiation dose evaluation is important in patients with malignant tumors, and this is especially critical in children with NB who will be receiving several dose of therapeutic 131I. The accurate quantification of the isotope-labeled analog can only be achieved by using positron emission compounds, such as 124I. Unlike planar images, which were used to obtain kinetic information, and SPECT reconstruction modalities that were aimed to assess the spatial distribution of radioactivity, 3D PET imaging-based dosimetry is a method which provides a more accurate estimation of the cumulated radioactivity distribution. Because PET provides better quantitative accuracy, when compared to SPECT regarding the tissue absorbed information, we hypothesize PET would better correspond with tumor response and normal organ toxicity. Early studies using I-124 for dosimetry in thyroid cancer have been promising.
Demonstration of the feasibility and accuracy of this new imaging modality, with the excellent prospect for more accurate dosimetry, will improve tumor localization and optimize therapeutic dosing with 131I-MIBG. The results of our work may potentially have also implications in the study of other neuroendocrine tumors. The Section of Nuclear Medicine and the Laboratory of Functional Imaging at the University of California, San Francisco, are equipped with state of the art instruments and is run by a highly skilled staff which will guarantee the success of the proposed research.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 124I-MIBG no-carrier added | Experimental | Drug: 124I-Metaiodobenzylguanidine (MIBG) (no-carrier added), Procedure: Positron Emission Tomography (PET) /Computerized tomography (CT)Patients are 3 years of age and older with relapsed or refractory neuroblastoma who are currently enrolled on a treatment protocol with 131I-MIBG. |
| 124I-MIBG carrier added | Experimental | Drug: 124I-MIBG (carrier added), Procedure: Positron Emission Tomography (PET) /Computerized tomography (CT)Patients are 3 years of age and older with relapsed or refractory neuroblastoma who are currently enrolled on a treatment protocol with 131I-MIBG. |
| Imaging Only | Active comparator | Procedure: Positron Emission Tomography (PET) /Computerized tomography (CT)Participants with high-risk neuroblastoma will receive imaging only without 124I-MIBG |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must be >/= 3 years of age and able to cooperate for the PET CT scan when registered on study.
- Patients must have a diagnosis of neuroblastoma either by histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamine metabolites.
- Recurrent/progressive disease at any time. Biopsy is not required, even if there is a partial response to intervening therapy or
- Refractory disease (i.e. less than a partial response to frontline therapy, including a minimum of 4 cycles of chemotherapy). No biopsy is required for eligibility for this study.
- 123I-MIBG Uptake: Patients must have MIBG evaluable disease which is defined as evidence of uptake into tumor at one site within 4 weeks prior to entry on study and subsequent to any intervening therapy.
Key exclusion criteria (2 listed)
- Pregnancy or lactating with the intent of breast feeding.
- Patients who require general anesthesia for MIBG imaging studies.
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 |
|---|---|---|
| 124I-Metaiodobenzylguanidine (MIBG) (no-carrier added)Also: 124I MIBG, MIBG124I-MIBG (no-carrier added) Administration (infusion, 1-2 minutes) followed by sequential PET/CT dosimetry scans on Days 0, 1, 2 and 5. Optional 124I-MIBG (no-carrier added) Administration \& PET/CT scan 6 weeks later. | Drug | 124I-MIBG no-carrier added |
| 124I-MIBG (carrier added)Also: 124I MIBG, MIBG124I-MIBG (carrier added) Administration (infusion, 60 minutes) followed by sequential PET/CT dosimetry scans on Days 0, 1, 2 and 5. Optional 124I-MIBG (carrier added) Administration \& PET/CT scan 6 weeks later. | Drug | 124I-MIBG carrier added |
| Positron Emission Tomography (PET) /Computerized tomography (CT)Also: PET/CTA PET scan measures important body functions, such as metabolism. CT imaging uses special x-ray equipment, and in some cases a contrast material, to produce multiple images of the inside of the body. Combined PET/CT scans combine the processes of both a PET and CT at the same time. | Procedure or surgery | 124I-MIBG carrier added, 124I-MIBG no-carrier added, Imaging Only |
Primary outcome
Measurements of organ dosimetry using high specific activity (no carrier added)
Time frame: Up to 7 weeks
Descriptive statistics for each organ dose obtained from the organ dosimetry data will be reported, to demonstrate organ dosimetry calculations are feasible and concordant with prior calculations in prior conjugate planar dosimetry imaging studies and our pre-clinical murine models
Measurements of organ dosimetry using low specific activity (carrier added)
Time frame: Up to 7 weeks
Descriptive statistics for each organ dose obtained from the organ dosimetry data will be reported, to demonstrate organ dosimetry calculations are feasible and concordant with prior calculations in prior conjugate planar dosimetry imaging studies and our pre-clinical murine models
Number of participants with grade 3 or 4 imaging-related toxicities.
Time frame: Up to 7 weeks
All patients will have toxicity monitoring for 6 weeks following 124I-MIBG administration. Toxicities will be graded according to the NCI Common Toxicity Criteria for Adverse Events (CTCAEv4.0)and attribution assigned.
Change from baseline of blood pressure
Time frame: Up to 7 weeks
Blood pressure will be recorded before, during, end injection and post-injection at baseline, days 1, 2 and 5 and again at week 7 if participants choose to have optional week 7 scan
Change from baseline of pulse measurements
Time frame: Up to 7 weeks
Participants pulse will be recorded before, during, end injection and post-injection at baseline, days 1, 2 and 5 and again at week 7 if participants choose to have optional week 7 scan
3 secondary outcomes
Measurements of tumor dosimetry using low specific activity (carrier added)
Time frame: Up to 7 weeks
Measurements of tumor dosimetry using high specific activity (no carrier added)
Time frame: Up to 7 weeks
Assessment of the accuracy of tumor imaging
Time frame: Up to 7 weeks
Results and safety
The study was stopped early (reason given: Funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Individual participant dataSharing planned: No
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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.
Katherine Matthay, MD principal investigator
University of California, San Francisco
Jose Miguel Hernandez-Pampaloni, MD, PhD principal investigator
University of California, San Francisco
Youngho Seo, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 124I-Metaiodobenzylguanidine (MIBG) (no-carrier added), 124I-MIBG (carrier added) and Positron Emission Tomography (PET) /Computerized tomography (CT) in people with Neuroblastoma, run by Miguel Pampaloni 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 9 inclusion and 2 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: stopped early, as of the sponsor's last update on 14 May 2021. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: Funding). Results are not available in the source record.
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?
Measurements of organ dosimetry using high specific activity (no carrier added) (time frame: Up to 7 weeks). The study lists 5 primary outcomes in all. 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 14 May 2021.