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68Ga-DOTATATE Neuroblastoma Imaging Pilot

ConditionNeuroblastoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 21
SponsorCentre de recherche du Centre hospitalier universitaire de Sherbrooke

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Radiopharmaceutical 68Ga-DOTATATE

    Biological/Vaccine

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Single arm with 68Ga-DOTATATEExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Accrual rate

Number of participants enrolled / year

Time frame
For the duration of the study, lasting 6 years
2

Rate of adverse events

Number of adverse events (being serious or not) associated to the intervention (injection of 68Ga-DOTATATE and PET/CT acquisition

Time frame
Up to 24 hours following injection of 68Ga-DOTATATE

Secondary outcomes

1

Positive lesions for 68Ga-DOTATATE

SUV mean of the lesion

Time frame
One hour post-injection of 68Ga-DOTATATE
2

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

the number of discordant lesions divided by the number of total positive lesions is the discordance rate

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Lead sponsor

Source ClinicalTrials.gov
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