68Ga-DOTATATE Neuroblastoma Imaging Pilot

Phase 2

Recruiting

• Conditions: Neuroblastoma
• Interventions: Biological: Radiopharmaceutical 68Ga-DOTATATE

• Registration Number: NCT04559217
• Lead Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke

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.

Study Timeline

• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-22
• Study Start: 2021-12-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-23
• Primary Completion: 2026-12-15
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm with 68Ga-DOTATATE	Radiopharmaceutical 68Ga-DOTATATE	all participants will undergo a PET scan with 68Ga-DOTATATE

Primary Outcome Measures

Name	Time	Method
Accrual rate	For the duration of the study, lasting 6 years	Number of participants enrolled / year
Rate of adverse events	Up to 24 hours following injection of 68Ga-DOTATATE	Number of adverse events (being serious or not) associated to the intervention (injection of 68Ga-DOTATATE and PET/CT acquisition

Secondary Outcome Measures

Name	Time	Method
Positive lesions for 68Ga-DOTATATE	One hour post-injection of 68Ga-DOTATATE	SUV mean of the lesion
Discordance of positive lesions for 68Ga-DOTATATE and positive lesions of 123I-MIBG	Within one week (period between 123I-MIBG scan and 68Ga-DOTATATE scan)	the number of discordant lesions divided by the number of total positive lesions is the discordance rate

Trial Locations

Locations (3)

McGill University Health Center - Children's hospital; 🇨🇦 Montréal, Quebec, Canada

CHU Ste-Justine; 🇨🇦 Montréal, Quebec, Canada

CIUSSS de l'Estrie-CHUS Hospital; 🇨🇦 Sherbrooke, Quebec, Canada