68Ga-DOTATATE Neuroblastoma Imaging Pilot

NCT04559217 · tracked via the Priya Life Science Canada tracker

Sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Phase

Phase 2

Started

2021-12-06

Last updated

2026-05-27

Condition(s) studied

Neuroblastoma

Investigational drug(s) / intervention(s)

Radiopharmaceutical 68Ga-DOTATATE

Radiopharmaceutical 68Ga-DOTATATE: Injection of 68Ga-DOTATATE followed by PET/CT acquisition

Study 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.

Eligibility

Sex

ALL

Min age

—

Max age

21 Years

Healthy volunteers

Inclusion Criteria: * 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). Exclusion Criteria: * 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

Primary outcome measure(s)

Accrual rate — For the duration of the study, lasting 6 years
Number of participants enrolled / year
Rate of adverse events — Up to 24 hours following injection of 68Ga-DOTATATE
Number of adverse events (being serious or not) associated to the intervention (injection of 68Ga-DOTATATE and PET/CT acquisition

Trial sites (3)

Facility	City	Region	Status
McGill University Health Center - Children's hospital	Montreal	Quebec	Withdrawn
CHU Ste-Justine	Montreal	Quebec	Recruiting
CIUSSS de l'Estrie-CHUS Hospital	Sherbrooke	Quebec	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04559217 on ClinicalTrials.gov ↗ ← All trials in Canada