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Not yet recruiting NCT07111117

Comparison of 18F Labeled Analog of MIBG (18F-MFBG) PET/CT and 123I-MIBG SPECT in Pediatric Patients With Neuroblastoma.

Phase II Interventional Neuroblastoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 18F-MFBG PET/CT imaging.
Who it may be relevant to
Registry conditions: Neuroblastoma. Basic parameters: 365 Days — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparison of 18F Labeled Analog of MIBG (18F-MFBG) PET/CT and 123I-MIBG SPECT in Pediatric Patients With Neuroblastoma

Overview

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).

Interventions

  • Procedure 18F-MFBG PET/CT imaging
    Participants will receive the 18F-MFBG tracer and undergo a PET/CT imaging.

Primary outcome measures

  • Diagnostic agreement between 18F-MFBG PET/CT (new procedure) and 123I-MIBG scintigraphy (gold standard) [Time frame: The day of the PET/CT procedure]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 3 centers
  • Institut Curie — Paris
  • Hôpital Armand Trousseau — Paris
  • Gustave Roussy — Villejuif

Identifiers

NCT: NCT07111117 · IC 2021-11

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗