NeuroblastomaPhase 2NEUROBLASTOTEPNCT07111117
Comparison of 18F Labeled Analog of MIBG (18F-MFBG) PET/CT and 123I-MIBG SPECT in Pediatric Patients With Neuroblastoma.
A Phase 2 study testing 18F-MFBG PET/CT imaging in people with Neuroblastoma, run by Institut Curie at 3 sites in France.
Trial summary
The goals of the NEUROBLASTOTEP trial is to compare the diagnostics performance of a the 18F-metafluorobenzylguanidine (18F-MFBG) Positron Emission Tomography / Computed Tomography scan (PET/CT) compared to 123I-metaiodobenzylguanidine (123I-MIBG scintigraphy (current gold standard) for imaging in neuroblastoma. Read more about this study
- Who is it for?
- Ages 365 days to 17 years
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- 18F-MFBG PET/CT imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Mar 2026to Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 365 days to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with histologically proven neuroblastoma.
- Relapsed or refractory neuroblastoma.
- 123I-MIBG avid neuroblastoma (positive 123I-MIBG scintigraphy = showing at least one neuroblastoma lesion (either primary or metastatic) with a significant avidity for 123I-MIBG), performed within 2 weeks to 2 days prior to 18F-MFBG PET/CT.
- No specific treatment for neuroblastoma between 123I-MIBG scintigraphy and 18F-MFBG PET/CT (PET/CT shall not delay therapeutic management.)
- Age ≥ 365 days to < 18 years old. For children under 13 months, day of birth should be collected.
- Weight ≥ 9 kg.
Show all 9Show fewer
- Performance Status: Lansky or Karnofsky ≥ 60%.
- Signed written informed consent by the 2 holders of the parental authority or legal representative(s).
- Patients covered by a health insurance system.
Who cannot join
- Patient inability to comply with protocol requirements without general anesthesia.
- Pregnant or breastfeeding patient. If indicated, at the investigator's discretion, patients of childbearing potential should have urinary pregnancy test the day of the PET/CT procedure, prior to the MFBG administration.
- Any treatment likely to interact with MIBG initiated/modified between scintigraphy with MIBG and PET/CT with MFBG.
- Patient with a parent or legal representative with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid informed consent
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
Institut Curie
Paris, 75005
Hubert Tissot, MD, +33156245990, hubert.tissot@curie.fr
Hôpital Armand Trousseau
Paris, 75012
Benedicte Jonca, MD, +33171738195, benedicte.jonca@aphp.fr
Gustave Roussy
Villejuif, 94805
Desiree Deandreis, MD, +33142116095, desiree.deandreis@gustaveroussy.fr
About this study
Official title: Comparison of 18F Labeled Analog of MIBG (18F-MFBG) PET/CT and 123I-MIBG SPECT in Pediatric Patients With Neuroblastoma
The goals of the NEUROBLASTOTEP trial is to compare the diagnostics performance of a the 18F-metafluorobenzylguanidine (18F-MFBG) Positron Emission Tomography / Computed Tomography scan (PET/CT) compared to 123I-metaiodobenzylguanidine (123I-MIBG scintigraphy (current gold standard) for imaging in neuroblastoma.
Read the detailed description
Neuroblastoma is one of the most common malignancies of childhood: 130 to 150 new cases are recorded each year in France. Currently, 123I-metaiodobenzylguanidine scintigraphy (123I-MIBG scan) is considered as a gold standard in neuroblastoma for assessing metastatic extension, as well as planning and evaluating response to treatment or detecting relapse. Regretfully, 123I-MIBG scintigraphy implies many disadvantages for our patients, mainly the length of the procedure (planned on two consecutive days), length of the imaging (45-90 minutes) and the required premedication for thyroid protection.
18F-metafluorobenzylguanidine (18F-MFBG) is a new specific Positron Emission Tomography (PET) tracer providing a specific Norepinephrine transporter (NET) expressing imaging with fluor-18, a routinely available radionuclide that offers higher resolution for lesion detection and shorter acquisitions for pediatric patients, and potentially lower radiation exposure.
The NEUROBLASTOTEP trial aims at demonstrating that 18F-MFBG PET/CT diagnostic performances are at least as good as 123I-MIBG scintigraphy (current gold standard imaging radiotracer in neuroblastoma).
- Conditions
- Neuroblastoma
- Being tested
- 18F-MFBG PET/CT imaging
- Keywords
- Neuroblastoma, PET / CT, Imaging, Radiotracer
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-MFBG PET/CT imagingProcedure or surgery
Participants will receive the 18F-MFBG tracer and undergo a PET/CT imaging.
| Study group | Role | What they receive |
|---|---|---|
| 18F-MFBG PET/CT imaging | Experimental | Participants will receive the 18F-MFBG tracer and undergo a PET/CT imaging. Receives: Procedure: 18F-MFBG PET/CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic agreement between 18F-MFBG PET/CT (new procedure) and 123I-MIBG scintigraphy (gold standard)
% patients in whom concordance between the 2 procedures is reached.
Measured: The day of the PET/CT procedure
Secondary outcomes (5)
Description of discrepancies
In case of non-perfect agreement, the observed discrepancies will be described. Agreement between the SIOPEN and Curie scores will be estimated.
Measured: The day of the PET/CT procedure
Dosimetric comparison between the two procedures
One-point activity concentration measurement for normal organs (lung, liver, renal parenchyma, pancreas, spleen, adrenal gland, bladder, thyroid, heart, gonadic, eyes).
Measured: The day of the PET/CT procedure
Improvement of patient management during the diagnostic procedure
Improvement of patient management will be evaluated by a short satisfaction survey after PET procedure, using satisfaction scales. The satisfaction and feeling variables will be described for the 123I-MIBG scintigraphy and 18F-MFBG PET/CT examinations by their repartition for the qualitative variables and by their distribution
Measured: The day of the PET/CT procedure
Optimization the 18F-MFBG PET procedure (dose injected, imaging protocol)
PET images will be acquired in list-mode to ensure multiple reconstruction for different acquisition duration, in order to determine optimal duration.
Measured: The day of the PET/CT procedure
Optimization the 18F-MFBG PET procedure (dose injected, imaging protocol)
PET images will be acquired in list-mode to ensure multiple reconstruction for different acquisition duration, in order to determine optimal injected activity
Measured: The day of the PET/CT procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Mar 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Neuroblastotep is a phase II, national, multicenter, prospective, interventional, open-label, non-randomized, single-arm pilot study (each patient being his own control). It is a concordance study comparing 18F-MFBG PET (= new diagnostic procedure) to 123I-MIBG scintigraphy (= gold standard) in neuroblastoma. 18F-MFBG is the radiopharmaceutical product.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tissot Hubert, MD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111117
- Sponsor's protocol ID
- IC 2021-11
- Acronym
- NEUROBLASTOTEP
- Status last verified
- Jul 2025
- First submitted
- 10 Jan 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 18F Labeled Analog of MIBG (18F-MFBG) PET/CT and 123I-MIBG SPECT in Pediatric Patients With Neuroblastoma
- ClinicalTrials.gov ID
- NCT07111117
- Acronym / sponsor ID
- NEUROBLASTOTEP / IC 2021-11
- Conditions
- Neuroblastoma
- Keywords
- Neuroblastoma, PET / CT, Imaging, Radiotracer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 8 Aug 2025 (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.
The goals of the NEUROBLASTOTEP trial is to compare the diagnostics performance of a the 18F-metafluorobenzylguanidine (18F-MFBG) Positron Emission Tomography / Computed Tomography scan (PET/CT) compared to 123I-metaiodobenzylguanidine (123I-MIBG scintigraphy (current gold standard) for imaging in neuroblastoma.
Detailed description
Neuroblastoma is one of the most common malignancies of childhood: 130 to 150 new cases are recorded each year in France. Currently, 123I-metaiodobenzylguanidine scintigraphy (123I-MIBG scan) is considered as a gold standard in neuroblastoma for assessing metastatic extension, as well as planning and evaluating response to treatment or detecting relapse. Regretfully, 123I-MIBG scintigraphy implies many disadvantages for our patients, mainly the length of the procedure (planned on two consecutive days), length of the imaging (45-90 minutes) and the required premedication for thyroid protection.
18F-metafluorobenzylguanidine (18F-MFBG) is a new specific Positron Emission Tomography (PET) tracer providing a specific Norepinephrine transporter (NET) expressing imaging with fluor-18, a routinely available radionuclide that offers higher resolution for lesion detection and shorter acquisitions for pediatric patients, and potentially lower radiation exposure.
The NEUROBLASTOTEP trial aims at demonstrating that 18F-MFBG PET/CT diagnostic performances are at least as good as 123I-MIBG scintigraphy (current gold standard imaging radiotracer in neuroblastoma).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Neuroblastotep is a phase II, national, multicenter, prospective, interventional, open-label, non-randomized, single-arm pilot study (each patient being his own control). It is a concordance study comparing 18F-MFBG PET (= new diagnostic procedure) to 123I-MIBG scintigraphy (= gold standard) in neuroblastoma. 18F-MFBG is the radiopharmaceutical product.
| Arm | Type | Receives |
|---|---|---|
| 18F-MFBG PET/CT imaging | Experimental | Procedure: 18F-MFBG PET/CT imagingParticipants will receive the 18F-MFBG tracer and undergo a PET/CT imaging. |
Who may qualify
- Ages
- 365 days to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Patients with histologically proven neuroblastoma.
- Relapsed or refractory neuroblastoma.
- 123I-MIBG avid neuroblastoma (positive 123I-MIBG scintigraphy = showing at least one neuroblastoma lesion (either primary or metastatic) with a significant avidity for 123I-MIBG), performed within 2 weeks to 2 days prior to 18F-MFBG PET/CT.
- No specific treatment for neuroblastoma between 123I-MIBG scintigraphy and 18F-MFBG PET/CT (PET/CT shall not delay therapeutic management.)
- Age ≥ 365 days to < 18 years old. For children under 13 months, day of birth should be collected.
Key exclusion criteria (4 listed)
- Patient inability to comply with protocol requirements without general anesthesia.
- Pregnant or breastfeeding patient. If indicated, at the investigator's discretion, patients of childbearing potential should have urinary pregnancy test the day of the PET/CT procedure, prior to the MFBG administration.
- Any treatment likely to interact with MIBG initiated/modified between scintigraphy with MIBG and PET/CT with MFBG.
- Patient with a parent or legal representative with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid informed consent
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-MFBG PET/CT imagingParticipants will receive the 18F-MFBG tracer and undergo a PET/CT imaging. | Procedure or surgery | 18F-MFBG PET/CT imaging |
Primary outcome
Diagnostic agreement between 18F-MFBG PET/CT (new procedure) and 123I-MIBG scintigraphy (gold standard)
Time frame: The day of the PET/CT procedure
% patients in whom concordance between the 2 procedures is reached.
5 secondary outcomes
Description of discrepancies
Time frame: The day of the PET/CT procedure
Dosimetric comparison between the two procedures
Time frame: The day of the PET/CT procedure
Improvement of patient management during the diagnostic procedure
Time frame: The day of the PET/CT procedure
Optimization the 18F-MFBG PET procedure (dose injected, imaging protocol)
Time frame: The day of the PET/CT procedure
Optimization the 18F-MFBG PET procedure (dose injected, imaging protocol)
Time frame: The day of the PET/CT procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies
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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.
Tissot Hubert, MD principal investigator
Institut Curie
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F-MFBG PET/CT imaging in people with Neuroblastoma, run by Institut Curie at 3 sites in France.
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 4 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: opening soon, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carole Cagnot (+33147111891, carole.cagnot@curie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic agreement between 18F-MFBG PET/CT (new procedure) and 123I-MIBG scintigraphy (gold standard) (time frame: The day of the PET/CT procedure). 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 3 Sep 2025.