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68Ga-DOTATATE Imaging for Neuroblastoma

Phase 2
Recruiting
Led By Etienne Rousseau, MD, FRCPC
Research Sponsored by Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Newly suspected or biopsy-proven neuroblastoma or recurrence of neuroblastoma
Aged between 1 day and 21 years old (inclusively)
Must not have
History of another cancer in the past 5 years other than non-melanomatous skin cancer
Medically unstable or unable to undergo scan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for the duration of the study, lasting 6 years
Awards & highlights

Summary

This trial is testing two different imaging strategies to see which is more effective in diagnosing and treating neuroblastoma in children.

Who is the study for?
This trial is for children and young adults up to 21 years old with new or recurring neuroblastoma. Participants must be able to give consent in French or English, have a planned 123I-MIBG imaging, and not currently be under treatment or part of another randomized control trial.
What is being tested?
The study tests the safety and effectiveness of a radiopharmaceutical called 68Ga-DOTATATE in detecting neuroblastoma compared to the current standard, which uses 123I-MIBG imaging. It aims to see if this new method can provide clearer results.
What are the potential side effects?
Potential side effects may include allergic reactions related to somatostatin analogues (the drug family that includes 68Ga-DOTATATE). The exact side effects are being studied as part of this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a new or returning neuroblastoma diagnosis.
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I am 21 years old or younger.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had any cancer other than non-melanoma skin cancer in the last 5 years.
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I am too ill or unable to undergo scans.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for the duration of the study, lasting 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and for the duration of the study, lasting 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Accrual rate
Rate of adverse events
Secondary study objectives
Discordance of positive lesions for 68Ga-DOTATATE and positive lesions of 123I-MIBG
Positive lesions for 68Ga-DOTATATE

Side effects data

From 2022 Phase 1 & 2 trial • 6 Patients • NCT04538950
33%
Mild atrial fibrillation
17%
Mild vomiting
17%
Moderate Sepsis
17%
Moderate chest pain
17%
Mild Ileus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Checkpoint Inhibitor (ICI)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single arm with 68Ga-DOTATATEExperimental Treatment1 Intervention
all participants will undergo a PET scan with 68Ga-DOTATATE

Find a Location

Who is running the clinical trial?

Centre de recherche du Centre hospitalier universitaire de SherbrookeLead Sponsor
61 Previous Clinical Trials
33,494 Total Patients Enrolled
Etienne Rousseau, MD, FRCPCPrincipal InvestigatorCIUSSSE-CHUS

Media Library

Radiopharmaceutical 68Ga-DOTATATE 2023 Treatment Timeline for Medical Study. Trial Name: NCT04559217 — Phase 2
~9 spots leftby Dec 2026
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