Neuroblastoma is the most frequent extracranial childhood tumor, with an annual incidence of approximately 10.2 per million children. Staging of the disease can be done by different imaging strategies (CT, MRI, scintigraphy and PET/CT). Discrepancies may be observed among these different strategies resulting in different treatment strategies. The goal of this study is to assess the feasibility and safety of 68Ga-DOTATATE and to compare it to 123I-MIBG when investigating neuroblastoma.
Background: Neuroblastoma is the most frequent extracranial childhood tumor, with an annual incidence of approximately 10.2 per million children. Initial staging of the disease and monitoring of the treatment response can be performed with different imaging modalities that include contrast-enhanced computed tomography (ceCT), ultrasound, magnetic resonance imaging (MRI), bone scintigraphy and 123I-MIBG scintigraphy. Another potential target for neuroblastoma imaging is the somatostatin receptor (SSTR) that is present in many neuroendocrine tumours (NET). The superior PET imaging technology used with new radiotracers (such as 68Ga-DOTATATE) enables imaging at advantageous resolutions well below what is possible by current clinical SPECT systems that are used for 123I-MIBG. Design: Prospective single-arm non-randomized clinical trial (phase II) - pilot Objective: 1) Assess the feasibility and safety of 68Ga-DOTATATE PET/CT imaging in patients with neuroblastoma or suspected of having neuroblastoma. 2) Compare lesion-by-lesion the uptake of 68Ga-DOTATATE and 123I-MIBG in the same participant. Study population: Children and adults with biopsy-proven or suspected neuroblastoma Procedure and Follow-up: Few days after 123I-MIBG scan, participants will undergo a 68Ga-DOTA-cTATE PET/CT scan (duration 2 hours). Clinical data will be collected from this imaging and from the participant's medical record (demographic, treatment, medication, pathology, lab test results) for a 2-year follow-up period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Injection of 68Ga-DOTATATE followed by PET/CT acquisition
McGill University Health Center - Children's hospital
Montreal, Quebec, Canada
WITHDRAWNCHU Ste-Justine
Montreal, Quebec, Canada
RECRUITINGCIUSSS de l'Estrie-CHUS Hospital
Sherbrooke, Quebec, Canada
RECRUITINGAccrual rate
Number of participants enrolled / year
Time frame: For the duration of the study, lasting 6 years
Rate of adverse events
Number of adverse events (being serious or not) associated to the intervention (injection of 68Ga-DOTATATE and PET/CT acquisition
Time frame: Up to 24 hours following injection of 68Ga-DOTATATE
Positive lesions for 68Ga-DOTATATE
SUV mean of the lesion
Time frame: One hour post-injection of 68Ga-DOTATATE
Discordance of positive lesions for 68Ga-DOTATATE and positive lesions of 123I-MIBG
the number of discordant lesions divided by the number of total positive lesions is the discordance rate
Time frame: Within one week (period between 123I-MIBG scan and 68Ga-DOTATATE scan)
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Enrollment
20