68Ga-DOTATATE Neuroblastoma Imaging Pilot
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiopharmaceutical 68Ga-DOTATATE.
- Who it may be relevant to
- Registry conditions: Neuroblastoma. Basic parameters: up to 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pilot Study of 68Ga-DOTATATE PET/CT and 123I-MIBG Scintigraphy Imaging of Neuroblastoma
Overview
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.
Detailed description
Background: Neuroblastoma is the most frequent extracranial childhood tumor, with an annual incidence of approximately 10.2 per million children. Initial staging of the disease and monitoring of the treatment response can be performed with different imaging modalities that include contrast-enhanced computed tomography (ceCT), ultrasound, magnetic resonance imaging (MRI), bone scintigraphy and 123I-MIBG scintigraphy.
Another potential target for neuroblastoma imaging is the somatostatin receptor (SSTR) that is present in many neuroendocrine tumours (NET). The superior PET imaging technology used with new radiotracers (such as 68Ga-DOTATATE) enables imaging at advantageous resolutions well below what is possible by current clinical SPECT systems that are used for 123I-MIBG.
Design: Prospective single-arm non-randomized clinical trial (phase II) - pilot
Objective: 1) Assess the feasibility and safety of 68Ga-DOTATATE PET/CT imaging in patients with neuroblastoma or suspected of having neuroblastoma. 2) Compare lesion-by-lesion the uptake of 68Ga-DOTATATE and 123I-MIBG in the same participant.
Study population: Children and adults with biopsy-proven or suspected neuroblastoma
Procedure and Follow-up: Few days after 123I-MIBG scan, participants will undergo a 68Ga-DOTA-cTATE PET/CT scan (duration 2 hours). Clinical data will be collected from this imaging and from the participant's medical record (demographic, treatment, medication, pathology, lab test results) for a 2-year follow-up period.
Interventions
- Biological Radiopharmaceutical 68Ga-DOTATATE
Injection of 68Ga-DOTATATE followed by PET/CT acquisition
Primary outcome measures
- Accrual rate [Time frame: For the duration of the study, lasting 6 years]
- Rate of adverse events [Time frame: Up to 24 hours following injection of 68Ga-DOTATATE]
Secondary outcome measures (2)
- Positive lesions for 68Ga-DOTATATE [Time frame: One hour post-injection of 68Ga-DOTATATE]
- Discordance of positive lesions for 68Ga-DOTATATE and positive lesions of 123I-MIBG [Time frame: Within one week (period between 123I-MIBG scan and 68Ga-DOTATATE scan)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Canada · 3 centers
- McGill University Health Center - Children's hospital — Montreal
- CHU Ste-Justine — Montreal
- CIUSSS de l'Estrie-CHUS Hospital — Sherbrooke
Identifiers
NCT: NCT04559217 · 2021-3828