Recruiting
Phase 2

68Ga-DOTATATE

Sponsor:

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Code:

NCT04559217

Conditions

Neuroblastoma

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

Radiopharmaceutical 68Ga-DOTATATE

Study Details

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.

Conditions

Neuroblastoma

Study ID

NCT04559217

Start date

Dec 6, 2021

Status verified date

May, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Dec 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Single arm with 68Ga-DOTATATE

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

Interventions

Radiopharmaceutical 68Ga-DOTATATE

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

Primary outcome measure

  • Accrual rate [ Time Frame: For the duration of the study, lasting 6 years ]
  • Rate of adverse events [ Time Frame: Up to 24 hours following injection of 68Ga-DOTATATE ]

Central Contacts and Locations

Central contacts

Amelie Tetu, MSc

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

Locations

CHU Ste-Justine

Recruiting

Montreal, Quebec, Canada, J1H 5N4

Contacts

Marie Galopin

514-345-4931marie.galopin.hsj@ssss.gouv.qc.ca

Principal Investigator:

Sophie Turpin, MD

CIUSSS de l'Estrie-CHUS Hospital

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Etienne Croteau, PhD

819-346-1110etienne.croteau.ciussse-chus@ssss.gouv.qc.ca

Amelie Tetu, MSc

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

Principal Investigator:

Etienne Rousseau, MD, FRCPC

More Information

Sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Last update posted

May 27, 2026

Last verified

May, 2026

Keywords

  • imaging
  • 68Ga-Dotatate
  • 68Ga-Octreotate
  • positron emission tomography (PET)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre de recherche du Centre hospitalier universitaire de Sherbrooke on 2026-05-27.