NCT04559217RecruitingPhase 2
68Ga-DOTATATE Neuroblastoma Imaging Pilot
Pilot Study of 68Ga-DOTATATE PET/CT and 123I-MIBG Scintigraphy Imaging of Neuroblastoma
Source: ClinicalTrials.gov · Last updated 27 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 16 Sept 2020
- Start date
- 6 Dec 2021
- Primary completion date
- 15 Dec 2027
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Diseases
- Neuroblastoma, Childhood cancers
- NCT number
- NCT04559217
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 6 Dec 2021 to the primary completion date, 15 Dec 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Medical/surgical intervention on the tumour between 123I-MIBG and 68Ga-DOTATATE PET/CT scan.
- Prior allergic reaction to somatostatin analogues
Other illness
- History of another cancer in the past 5 years other than non-melanomatous skin cancer.
Other
- Currently under a randomized control trial with unknown allocation;
- Currently under treatment;
- 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).
Who the study is looking for
- 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).
Age in the registry: - to 21 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Ste-Justine Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| McGill University Health Center - Children's hospital Coordinator of this site? Confirm its status | Montreal | Canada | Withdrawn |
| CIUSSS de l'Estrie- CHUS Hospital Coordinator of this site? Confirm its status | Sherbrooke | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.