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

Institut Curie

Status and phase: Begins enrollment this month; Phase 2

Conditions: Neuroblastoma

Treatments: Procedure: 18F-MFBG PET/CT imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT07111117

IC 2021-11

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 estimated patients

Sex: All

Ages: 365 days to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with histologically proven neuroblastoma.
2. Relapsed or refractory neuroblastoma.
3. 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.
4. No specific treatment for neuroblastoma between 123I-MIBG scintigraphy and 18F-MFBG PET/CT (PET/CT shall not delay therapeutic management.)
5. Age ≥ 365 days to < 18 years old. For children under 13 months, day of birth should be collected.
6. Weight ≥ 9 kg.
7. Performance Status: Lansky or Karnofsky ≥ 60%.
8. Signed written informed consent by the 2 holders of the parental authority or legal representative(s).
9. Patients covered by a health insurance system.

Exclusion criteria

1. Patient inability to comply with protocol requirements without general anesthesia.
2. 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.
3. Any treatment likely to interact with MIBG initiated/modified between scintigraphy with MIBG and PET/CT with MFBG.
4. 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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

18F-MFBG PET/CT imaging

Experimental group

Description:

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

Treatment:

Procedure: 18F-MFBG PET/CT imaging