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

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

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

Первичные конечные точки

• Diagnostic agreement between 18F-MFBG PET/CT (new procedure) and 123I-MIBG scintigraphy (gold standard) [Срок оценки: The day of the PET/CT procedure]

Вторичные конечные точки (5)

• Description of discrepancies [Срок оценки: The day of the PET/CT procedure]
• Dosimetric comparison between the two procedures [Срок оценки: The day of the PET/CT procedure]
• Improvement of patient management during the diagnostic procedure [Срок оценки: The day of the PET/CT procedure]
• Optimization the 18F-MFBG PET procedure (dose injected, imaging protocol) [Срок оценки: The day of the PET/CT procedure]
• Optimization the 18F-MFBG PET procedure (dose injected, imaging protocol) [Срок оценки: The day of the PET/CT procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 3 центра

• Institut Curie — Paris
• Hôpital Armand Trousseau — Paris
• Gustave Roussy — Villejuif

Идентификаторы

NCT: NCT07111117 · IC 2021-11

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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