Comparison of 18F Labeled Analog of MIBG (18F-MFBG) PET/CT and 123I-MIBG SPECT in Pediatric Patients With Neuroblastoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Diagnostic agreement between 18F-MFBG PET/CT (new procedure) and 123I-MIBG scintigraphy (gold standard)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 365 Days 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Diagnostic agreement between 18F-MFBG PET/CT (new procedure) and 123I-MIBG scintigraphy (gold standard)
时间窗: The day of the PET/CT procedure
% patients in whom concordance between the 2 procedures is reached.
次要结局
- Description of discrepancies(The day of the PET/CT procedure)
- Dosimetric comparison between the two procedures(The day of the PET/CT procedure)
- Optimization the 18F-MFBG PET procedure (dose injected, imaging protocol)(The day of the PET/CT procedure)
- Improvement of patient management during the diagnostic procedure(The day of the PET/CT procedure)