Clinical trial · Interventional
68Ga-DOTATATE Neuroblastoma Imaging Pilot
Pilot Study of 68Ga-DOTATATE PET/CT and 123I-MIBG Scintigraphy Imaging of Neuroblastoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiopharmaceutical 68Ga-DOTATATE | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm with 68Ga-DOTATATE
- description
- all participants will undergo a PET scan with 68Ga-DOTATATE
- interventionNames
- Biological: Radiopharmaceutical 68Ga-DOTATATE
Primary outcomes (2)
- measure
- Accrual rate
- timeFrame
- For the duration of the study, lasting 6 years
- description
- Number of participants enrolled / year
- measure
- Rate of adverse events
- timeFrame
- Up to 24 hours following injection of 68Ga-DOTATATE
- description
- Number of adverse events (being serious or not) associated to the intervention (injection of 68Ga-DOTATATE and PET/CT acquisition
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available