Neuroblastoma101-305NCT07833631
A Prospective Image Reevaluation Study to Assess the Efficacy of 18F-mFBG PET Imaging in Subjects With Neuroblastoma
An observational study of Neuroblastoma, run by Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) at 1 site in United States.
Trial summary
This is a prospective image revaluation study designed to assess the performance of 18F-mFBG PET imaging in detecting the presence of neuroblastoma. Eligible participants will have undergone 18F-mFBG PET imaging in a research trial or locally-authorized clinical use and have: a) an established diagnosis of active… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- 18F-MFBG
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 31 Aug 2026
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The planned population will consist of subjects with previously established presence or absence of active neuroblastoma. Individuals enrolled as healthy controls in 18F-mFBG trials may be included.
Who may be able to join
- a) The subject has undergone 18F-mFBG imaging in a previous research trial (including as a non-disease control) or locally-authorized clinical use.
- Disease status (+ or - for neuroblastoma) as of the date of 18F-mFBG imaging was established based on data collected as part of the previous clinical trial or locally-authorized clinical use or during subsequent clinical follow-up.
Who cannot join
- 1. There is insufficient correlative imaging and clinical follow-up data to establish subject disease status as of the date of 18F-mFBG imaging.
- 2. 18F-mFBG imaging from the previous trial was judged incomplete or uninterpretable.
Trial locations and contacts
1 site in 1 country.
United States1 site
Innervate Radiopharmaceuticals LLC
Englewood, New Jersey, 07631
About this study
This is a prospective image revaluation study designed to assess the performance of 18F-mFBG PET imaging in detecting the presence of neuroblastoma. Eligible participants will have undergone 18F-mFBG PET imaging in a research trial or locally-authorized clinical use and have: a) an established diagnosis of active neuroblastoma; or b) an established diagnosis of neuroblastoma in remission; or c) no history or current evidence of neuroblastoma based on signs, symptoms, imaging findings, and laboratory results.
Read the detailed description
This is a study involving blinded interpretation of existing 18F-mFBG PET images. No subjects will be administered 18F-mFBG. Previously collected 18F-mFBG PET studies will be evaluated by 5 independent radiologists and/or nuclear medicine physicians. They will have access to limited clinical information on the reason subject was undergoing evaluations at the time of 18F-mFBG imaging but be blinded to all other subject information. Blinded readers will record the findings on 18F-mFBG scans judged consistent with presence of neuroblastoma and the disease status (+ or -) of the subjects.
Subject-level performance of 18F-mFBG PET will be assessed on the basis of positive and negative percent agreement with presence of at least 1 lesion identified by a blinded reader confirmed as neuroblastoma on clinical standard-of-care imaging and histopathology evaluations. Region/organ system level diagnostic performance will be assessed on the basis of positive and negative percent agreement between the blinded 18F-mFBG scan interpretations and disease status in the corresponding region on clinical standard-of-care imaging and histopathology evaluations. Both assessments will utilize the clinical information gathered as part of the trials or locally-authorized clinical use in which the 18F-mFBG scans were acquired and relevant clinical follow-up available at the imaging sites.
- Conditions
- Neuroblastoma
- Being tested
- 18F-MFBG
- Keywords
- Diagnosis of Neuroblastoma
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-MFBGDrug
Quantity of 18F-mFBG administered to each subject was determined based on the protocol specifications of the original trial at each participating site. No 18F-mFBG will be administered in this study.
| Study group | Role | What they receive |
|---|---|---|
| 18F-mFBG Revaluation Group | Subjects previously administered 18F-mFBG with: a) a current diagnosis of neuroblastoma; b) a diagnosis of neuroblastoma in remission; or c) no history or current evidence of neuroblastoma. Receives: Drug: 18F-MFBG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine Sensitivity, Specificity, Positive and Negative Predictive Percent Agreement (PPA/NPA) of 18F-mFBG
The primary objective of this study is to demonstrate that 18F-mFBG PET scintigraphy (PET/CT or PET/MR) is sensitive and specific (in terms of positive and negative percent agreement (PPA and NPA) on a subject-level in confirming or excluding the presence of neuroblastoma.
Measured: Blinded Reader review over 2-3 weeks.
Secondary outcomes (1)
PPA/NPA on a region/organ system level
To demonstrate that 18F-mFBG PET scintigraphy (PET/CT or PET/MR) is sensitive and specific (in terms of positive and negative percent agreement (PPA and NPA)) on a region/organ system level in confirming or excluding the presence of neuroblastoma.
Measured: Blinded reader evaluation over 2-3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Jun 2026
- Primary completion30 Jul 2026
- Study completion31 Aug 2026
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arnold F Jacobson, MD PhD, Study director, Innervate Radiopharmaceuticals LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833631
- Sponsor's protocol ID
- IRP101-305
- Acronym
- 101-305
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Image Reevaluation Study to Assess the Efficacy of 18F-mFBG PET Imaging in Subjects With Neuroblastoma
- ClinicalTrials.gov ID
- NCT07833631
- Acronym / sponsor ID
- 101-305 / IRP101-305
- Conditions
- Neuroblastoma
- Keywords
- Diagnosis of Neuroblastoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 22 Sep 2026 (actual)
- 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 prospective image revaluation study designed to assess the performance of 18F-mFBG PET imaging in detecting the presence of neuroblastoma. Eligible participants will have undergone 18F-mFBG PET imaging in a research trial or locally-authorized clinical use and have: a) an established diagnosis of active neuroblastoma; or b) an established diagnosis of neuroblastoma in remission; or c) no history or current evidence of neuroblastoma based on signs, symptoms, imaging findings, and laboratory results.
Detailed description
This is a study involving blinded interpretation of existing 18F-mFBG PET images. No subjects will be administered 18F-mFBG. Previously collected 18F-mFBG PET studies will be evaluated by 5 independent radiologists and/or nuclear medicine physicians. They will have access to limited clinical information on the reason subject was undergoing evaluations at the time of 18F-mFBG imaging but be blinded to all other subject information. Blinded readers will record the findings on 18F-mFBG scans judged consistent with presence of neuroblastoma and the disease status (+ or -) of the subjects.
Subject-level performance of 18F-mFBG PET will be assessed on the basis of positive and negative percent agreement with presence of at least 1 lesion identified by a blinded reader confirmed as neuroblastoma on clinical standard-of-care imaging and histopathology evaluations. Region/organ system level diagnostic performance will be assessed on the basis of positive and negative percent agreement between the blinded 18F-mFBG scan interpretations and disease status in the corresponding region on clinical standard-of-care imaging and histopathology evaluations. Both assessments will utilize the clinical information gathered as part of the trials or locally-authorized clinical use in which the 18F-mFBG scans were acquired and relevant clinical follow-up available at the imaging sites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-mFBG Revaluation Group | – | Drug: 18F-MFBGSubjects previously administered 18F-mFBG with: a) a current diagnosis of neuroblastoma; b) a diagnosis of neuroblastoma in remission; or c) no history or current evidence of neuroblastoma. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The planned population will consist of subjects with previously established presence or absence of active neuroblastoma. Individuals enrolled as healthy controls in 18F-mFBG trials may be included.
Key inclusion criteria (2 listed)
- a) The subject has undergone 18F-mFBG imaging in a previous research trial (including as a non-disease control) or locally-authorized clinical use.
- Disease status (+ or - for neuroblastoma) as of the date of 18F-mFBG imaging was established based on data collected as part of the previous clinical trial or locally-authorized clinical use or during subsequent clinical follow-up.
Key exclusion criteria (2 listed)
- 1. There is insufficient correlative imaging and clinical follow-up data to establish subject disease status as of the date of 18F-mFBG imaging.
- 2. 18F-mFBG imaging from the previous trial was judged incomplete or uninterpretable.
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 |
|---|---|---|
| 18F-MFBGQuantity of 18F-mFBG administered to each subject was determined based on the protocol specifications of the original trial at each participating site. No 18F-mFBG will be administered in this study. | Drug | 18F-mFBG Revaluation Group |
Primary outcome
Determine Sensitivity, Specificity, Positive and Negative Predictive Percent Agreement (PPA/NPA) of 18F-mFBG
Time frame: Blinded Reader review over 2-3 weeks.
The primary objective of this study is to demonstrate that 18F-mFBG PET scintigraphy (PET/CT or PET/MR) is sensitive and specific (in terms of positive and negative percent agreement (PPA and NPA) on a subject-level in confirming or excluding the presence of neuroblastoma.
1 secondary outcome
PPA/NPA on a region/organ system level
Time frame: Blinded reader evaluation over 2-3 weeks.
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 22 Sep 2026.
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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.
Arnold F Jacobson, MD PhD study director
Innervate Radiopharmaceuticals LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroblastoma, run by Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) 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 2 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: finished, as of the sponsor's last update on 22 Sep 2026. 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.
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?
Determine Sensitivity, Specificity, Positive and Negative Predictive Percent Agreement (PPA/NPA) of 18F-mFBG (time frame: Blinded Reader review over 2-3 weeks.). 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 22 Sep 2026.