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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for the duration of the study, lasting 6 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have a new or returning neuroblastoma diagnosis.

Select...

I am 21 years old or younger.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for the duration of the study, lasting 6 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Accrual rate

Rate of adverse events

Secondary outcome measures

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 Ileus

17%

Moderate chest pain

17%

Mild vomiting

17%

Moderate Sepsis

100%

80%

60%

40%

20%

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre de recherche du Centre hospitalier universitaire de SherbrookeLead Sponsor

58 Previous Clinical Trials

31,145 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there availability for additional participants in this research?

"According to the information provided on clinicaltrials.gov, this medical investigation is open for patient recruitment and has been since December 6th 2021. It was last updated on May 24th 2022."

Answered by AI

What safety precautions should be taken when utilizing Radiopharmaceutical 68Ga-DOTATATE?

"Judging from the Phase 2 trial data, our team at Power assigned Radiopharmaceutical 68Ga-DOTATATE a score of 2 on its safety scale. While there is some evidence to suggest that it's safe to use, no clinical studies have yet proven efficacy."

Answered by AI

Have there been any prior investigations that have utilized Radiopharmaceutical 68Ga-DOTATATE?

"Presently, 5 studies concerning the Radiopharmaceutical 68Ga-DOTATATE are undergoing. None of those clinical trials have reached Phase 3 yet. Most sites for this investigation are in Rochester, Minnesota; however there are 7 locations conducting research on this therapy overall."

Answered by AI

What is the maximum number of participants for this research?

"Affirmative. According to the data on clinicaltrials.gov, this experiment is presently recruiting participants. This trial was initially posted on December 6th 2021 and has been refined most recently on May 24th 2022; 20 individuals are needed from two medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

68Ga-DOTATATE Neuroblastoma Imaging Pilot

2021. "68Ga-DOTATATE Neuroblastoma Imaging Pilot". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04559217.

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