NCT04559217

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
17mo left

Started Dec 2021

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Dec 2021Sep 2027

First Submitted

Initial submission to the registry

September 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

December 6, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

August 23, 2024

Status Verified

August 1, 2024

Enrollment Period

5 years

First QC Date

September 16, 2020

Last Update Submit

August 22, 2024

Conditions

Neuroblastoma

Keywords

imaging68Ga-Dotatate68Ga-Octreotatepositron emission tomography (PET)

Outcome Measures

Primary Outcomes (2)

  • Accrual rate

    Number of participants enrolled / year

    For the duration of the study, lasting 6 years

  • Rate of adverse events

    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 Outcomes (2)

  • Positive lesions for 68Ga-DOTATATE

    One hour post-injection of 68Ga-DOTATATE

  • Discordance of positive lesions for 68Ga-DOTATATE and positive lesions of 123I-MIBG

    Within one week (period between 123I-MIBG scan and 68Ga-DOTATATE scan)

Study Arms (1)

Single arm with 68Ga-DOTATATE

EXPERIMENTAL

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

Biological: Radiopharmaceutical 68Ga-DOTATATE

Interventions

Radiopharmaceutical 68Ga-DOTATATEBIOLOGICAL

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

Single arm with 68Ga-DOTATATE

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.
  • Prior allergic reaction to somatostatin analogues

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

McGill University Health Center - Children's hospital

Montreal, Quebec, H4A 3J1, Canada

WITHDRAWN

CHU Ste-Justine

Montreal, Quebec, J1H 5N4, Canada

RECRUITING

CIUSSS de l'Estrie-CHUS Hospital

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

MeSH Terms

Conditions

Neuroblastoma

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Etienne Rousseau, MD, FRCPC

    CIUSSSE-CHUS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amelie Tetu, MSc

CONTACT

819-346-1110amelie.tetu.ciussse-chus@ssss.gouv.qc.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Prospective pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2020

First Posted

September 22, 2020

Study Start

December 6, 2021

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

September 30, 2027

Last Updated

August 23, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)