Imaging neuroblastoma using 68Ga-DOTATATE
Pilot Study of 68Ga-DOTATATE PET/CT and 123I-MIBG Scintigraphy Imaging of Neuroblastoma
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 |
| Enrollment | 20 (estimated) |
| Ages | N/A to 21 Years |
| Sex | All |
| Sponsor | Centre de recherche du Centre hospitalier universitaire de Sherbrooke Academic / other |
| Locations | 3 sites (Montreal, Quebec and 2 other locations) |
| Trial ID | NCT04559217 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include children and adults aged 1 day to 21 years with newly suspected or biopsy-proven neuroblastoma.
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.
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 performed: While the use of 68Ga-DOTATATE for neuroblastoma imaging is a novel approach, similar imaging techniques have shown promise in other neuroendocrine tumors.
Eligibility criteria
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 this trial is running
Montreal, Quebec and 2 other locations
- McGill University Health Center - Children's hospital — Montreal, Quebec, Canada (Withdrawn)
- CHU Ste-Justine — Montreal, Quebec, Canada (Recruiting)
- CIUSSS de l'Estrie-CHUS Hospital — Sherbrooke, Quebec, Canada (Recruiting)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.