68Ga-DOTATATE Neuroblastoma Imaging Pilot

Sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke (Other)

Overall Status

Recruiting

CT.gov ID

NCT04559217

Collaborator

(none)

Enrollment

Locations

Arm

69.8

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuroblastoma	Biological: Radiopharmaceutical 68Ga-DOTATATE	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective pilot studyProspective pilot study

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Pilot Study of 68Ga-DOTATATE PET/CT and 123I-MIBG Scintigraphy Imaging of Neuroblastoma

Actual Study Start Date :

Dec 6, 2021

Anticipated Primary Completion Date :

Dec 15, 2026

Anticipated Study Completion Date :

Sep 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single arm with 68Ga-DOTATATE all participants will undergo a PET scan with 68Ga-DOTATATE	Biological: Radiopharmaceutical 68Ga-DOTATATE Injection of 68Ga-DOTATATE followed by PET/CT acquisition

Arm

Intervention/Treatment

Experimental: Single arm with 68Ga-DOTATATE

all participants will undergo a PET scan with 68Ga-DOTATATE

Biological: Radiopharmaceutical 68Ga-DOTATATE

Injection of 68Ga-DOTATATE followed by PET/CT acquisition

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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;
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