68Ga-DOTATATE Neuroblastoma Imaging Pilot

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-06

Study Completion Date

2027-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neuroblastoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective pilot study

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single arm with 68Ga-DOTATATE

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

Group Type EXPERIMENTAL

Radiopharmaceutical 68Ga-DOTATATE

Intervention Type BIOLOGICAL

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

Interventions

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Radiopharmaceutical 68Ga-DOTATATE

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No