Imaging neuroblastoma using 68Ga-DOTATATE
Official title: Pilot Study of 68Ga-DOTATATE PET/CT and 123I-MIBG Scintigraphy Imaging of Neuroblastoma
Run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke · NCT04559217 · Data updated 2026-11-12
This study is testing a new type of imaging called 68Ga-DOTATATE PET/CT to see if it works better and is safer than the standard method for detecting neuroblastoma in both children and adults.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | Any age to 21 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Centre de recherche du Centre hospitalier universitaire de Sherbrooke Academic / other |
| Locations | 3 sites (Montreal, Quebec and 2 other locations) |
| Status | Recruiting |
| Started | December 6, 2021 |
| Main results expected | December 15, 2027 |
| Study ends | September 30, 2028 |
| Registry record updated | May 27, 2026 |
| Trial ID | NCT04559217 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include children and adults aged 1 day to 21 years with newly suspected or biopsy-proven neuroblastoma.
✕Probably not a fit
Patients with a history of another cancer in the past 5 years or those currently undergoing treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study aims to evaluate the feasibility and safety of using 68Ga-DOTATATE PET/CT imaging in patients with neuroblastoma or those suspected of having the disease. It will compare the imaging results of 68Ga-DOTATATE with the traditional 123I-MIBG imaging method in the same participants. The study will involve children and adults who meet specific eligibility criteria, and data will be collected over a two-year period following the imaging procedures.
Why it matters
Potential benefit: If successful, this study could provide a more accurate and safer imaging method for diagnosing and monitoring neuroblastoma.
How similar studies have gone: While the use of 68Ga-DOTATATE for neuroblastoma imaging is a novel approach, similar imaging techniques have shown promise in other neuroendocrine tumors.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
CHU Ste-Justine
Montreal, Quebec, Canada Recruiting -
CIUSSS de l'Estrie-CHUS Hospital
Sherbrooke, Quebec, Canada Recruiting -
McGill University Health Center - Children's hospital
Montreal, Quebec, Canada Withdrawn
Study contacts
- Principal investigator: Etienne Rousseau, MD, FRCPC — Ciussse-Chus
- Study coordinator: Amelie Tetu, MSc
- Email: amelie.tetu.ciussse-chus@ssss.gouv.qc.ca
- Phone: 819-346-1110
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.