68Ga-DOTATATE Neuroblastoma Imaging Pilot

Recruiting now · Phase 2

Conditions studied: Neuroblastoma

In brief

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.

Key facts

Study ID

NCT04559217

Run by

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

People needed

20

Starts

2021-12-06

Expected to finish

2028-09-30

Last updated by the study team

2026-05-27

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly suspected or biopsy-proven neuroblastoma or recurrence of neuroblastoma
• Planned 123I-MIBG imaging
• Able and willing to provide signed informed consent in French or English (for the adult candidates or the parent/legal tutor of the pediatric candidates)
• Aged between 1 day and 21 years old (inclusively).

You may not qualify if…

• History of another cancer in the past 5 years other than non-melanomatous skin cancer.
• Currently under a randomized control trial with unknown allocation;
• Currently under treatment;
• Medical/surgical intervention on the tumour between 123I-MIBG and 68Ga-DOTATATE PET/CT scan.
• Medically unstable or unable to undergo scan.
• Pregnancy (breastfeeding is not an exclusion criterion but needs to be stopped for at least 12 hours after 68Ga-DOTATATE injection).
• Prior allergic reaction to somatostatin analogues

Where it is running

• CHU Ste-Justine — Montreal, Quebec, Canada (enrolling)
• CIUSSS de l'Estrie-CHUS Hospital — Sherbrooke, Quebec, Canada (enrolling)
• McGill University Health Center - Children's hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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