68Ga-DOTATATE Neuroblastoma Imaging Pilot

Phase 2

Recruiting

• Conditions: Neuroblastoma

• Registration Number: NCT04559217
• Lead Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-9-16
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Newly suspected or biopsy-proven neuroblastoma or recurrence of neuroblastoma<br><br> - Planned 123I-MIBG imaging<br><br> - Able and willing to provide signed informed consent in French or English (for the<br> adult candidates or the parent/legal tutor of the pediatric candidates)<br><br> - Aged between 1 day and 21 years old (inclusively).<br><br>Exclusion Criteria:<br><br> - History of another cancer in the past 5 years other than non-melanomatous skin<br> cancer.<br><br> - Currently under a randomized control trial with unknown allocation;<br><br> - Currently under treatment;<br><br> - Medical/surgical intervention on the tumour between 123I-MIBG and 68Ga-DOTATATE<br> PET/CT scan.<br><br> - Medically unstable or unable to undergo scan.<br><br> - Pregnancy (breastfeeding is not an exclusion criterion but needs to be stopped for<br> at least 12 hours after 68Ga-DOTATATE injection).<br><br> - Prior allergic reaction to somatostatin analogues

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accrual rate;Rate of adverse events

Secondary Outcome Measures

Name	Time	Method
Positive lesions for 68Ga-DOTATATE;Discordance of positive lesions for 68Ga-DOTATATE and positive lesions of 123I-MIBG