68Ga-DOTATATE Neuroblastoma Imaging Pilot

February 13, 2024 updated by: Centre de recherche du Centre hospitalier universitaire de Sherbrooke

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, J1H 5N4
        • Recruiting
        • CHU Ste-Justine
        • Contact:
        • Principal Investigator:
          • Sophie Turpin, MD
      • Montréal, Quebec, Canada, H4A 3J1
        • Not yet recruiting
        • McGill University Health Center - Children's hospital
        • Principal Investigator:
          • Sharon Abish, MD
        • Contact:
      • Sherbrooke, Quebec, Canada, J1H 5N4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accrual rate
Time Frame: For the duration of the study, lasting 6 years
Number of participants enrolled / year
For the duration of the study, lasting 6 years
Rate of adverse events
Time Frame: 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
Up to 24 hours following injection of 68Ga-DOTATATE

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Investigators

  • Principal Investigator: Etienne Rousseau, MD, FRCPC, Ciussse-Chus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2021

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

September 16, 2020

First Submitted That Met QC Criteria

September 16, 2020

First Posted (Actual)

September 22, 2020

Study Record Updates

Last Update Posted (Estimated)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-3828

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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