Clinical trial NCT04559217: 68Ga-DOTATATE Neuroblastoma Imaging Pilot
Official title: Pilot Study of 68Ga-DOTATATE PET/CT and 123I-MIBG Scintigraphy Imaging of Neuroblastoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Neuroblastoma
Keywords: imaging
68Ga-Dotatate
68Ga-Octreotate
positron emission tomography (PET)
Lead sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 20
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective pilot study
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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

Primary outcomes:
measure: Accrual rate
timeFrame: For the duration of the study, lasting 6 years
measure: Rate of adverse events
timeFrame: Up to 24 hours following injection of 68Ga-DOTATATE
Secondary outcomes:
measure: Positive lesions for 68Ga-DOTATATE
timeFrame: One hour post-injection of 68Ga-DOTATATE
measure: Discordance of positive lesions for 68Ga-DOTATATE and positive lesions of 123I-MIBG
timeFrame: Within one week (period between 123I-MIBG scan and 68Ga-DOTATATE scan)
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: McGill University Health Center - Children's hospital
state: Quebec
city: Montréal
country: Canada
facility: CHU Ste-Justine
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie-CHUS Hospital
state: Quebec
Study officials:
affiliation: CIUSSSE-CHUS
name: Etienne Rousseau, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: