NCT04559217

68Ga-DOTATATE Neuroblastoma Imaging Pilot

Pilot Study of 68Ga-DOTATATE PET/CT and 123I-MIBG Scintigraphy Imaging of Neuroblastoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Neuroblastoma

Interventions

Type	Name	Description
BIOLOGICAL	Radiopharmaceutical 68Ga-DOTATATE	Injection of 68Ga-DOTATATE followed by PET/CT acquisition

Timeline

• Start date: 2021-12-06
• Primary completion: 2026-12-15
• Completion: 2027-09-30
• First posted: 2020-09-22
• Last updated: 2024-08-23

Locations

3 sites across 1 country: Canada