Actively Recruiting
Pilot Study of 68Ga-DOTATATE PET/CT and 123I-MIBG Scintigraphy Imaging of Neuroblastoma
Led by Centre de recherche du Centre hospitalier universitaire de Sherbrooke · Updated on 2026-05-27
20
Participants Needed
3
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Neuroblastoma is the most common extracranial tumor in children, occurring at a rate of about 10.2 cases per million yearly. This study is a phase II pilot trial designed to assess the use of a new imaging method, 68Ga-DOTATATE PET/CT, for detecting neuroblastoma and compare it to the existing 123I-MIBG scan. Researchers aim to evaluate the feasibility and safety of 68Ga-DOTATATE and how accurately it identifies neuroblastoma lesions compared to 123I-MIBG. Participants will first undergo a 123I-MIBG scan followed by a 68Ga-DOTATATE PET/CT scan a few days later. The 68Ga-DOTATATE is a radiopharmaceutical injected into the patient, and imaging is done approximately one hour post-injection, lasting about two hours. This single-arm study includes children and young adults up to 21 years old who have biopsy-proven or suspected neuroblastoma. The study monitors adverse events within 24 hours after the 68Ga-DOTATATE injection. During the study, researchers will collect clinical data from the imaging scans and participants' medical records for up to two years, including demographics, treatments, medications, pathology, and laboratory tests. Outcome measurements focus on the rate of participant enrollment and any side effects from the 68Ga-DOTATATE injection, as well as lesion detection and differences between the two imaging methods. Participants' health status will be followed regularly to assess the imaging techniques' effectiveness and safety.
CONDITIONS
Brief Title
68Ga-DOTATATE Neuroblastoma Imaging Pilot
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 adults or parents/legal tutors of pediatric candidates)
- Aged between 1 day and 21 years old inclusive
You will not qualify if you...
- History of another cancer in the past 5 years other than non-melanomatous skin cancer
- Currently enrolled in a randomized control trial with unknown allocation
- Currently under treatment for neuroblastoma
- Medical or surgical intervention on the tumor between 123I-MIBG and 68Ga-DOTATATE PET/CT scans
- Medically unstable or unable to undergo scans
- Pregnancy (breastfeeding must be stopped for at least 12 hours after 68Ga-DOTATATE injection)
- Prior allergic reaction to somatostatin analogues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 week
Participants undergo two imaging scans: a 123I-MIBG scan followed a few days later by a 68Ga-DOTATATE PET/CT scan to assess neuroblastoma lesions.
2 imaging visits (in-person)
Duration - 2 years
Clinical data and medical records are collected to monitor safety and disease status over a 2-year period after imaging.
Data collected from medical records; no additional visits required
Trial Site Locations
Total: 3 locations
1
McGill University Health Center - Children's hospital
Montreal, Quebec, Canada, H4A 3J1
Withdrawn
2
CHU Ste-Justine
Montreal, Quebec, Canada, J1H 5N4
Actively Recruiting
3
CIUSSS de l'Estrie-CHUS Hospital
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
Research Team
A
Amelie Tetu, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here