NeuroblastomaPhase 2NCT04559217
68Ga-DOTATATE Neuroblastoma Imaging Pilot
A Phase 2 study testing Radiopharmaceutical 68Ga-DOTATATE in people with Neuroblastoma, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 3 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- Radiopharmaceutical 68Ga-DOTATATE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesCanada
- Study dates
- 6 Dec 2021to 30 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 2 recruiting
- Withdrawn
McGill University Health Center - Children's hospital
Montreal, Quebec, H4A 3J1
- Recruiting
CHU Ste-Justine
Montreal, Quebec, J1H 5N4
Marie Galopin, 514-345-4931 ext. 6326, marie.galopin.hsj@ssss.gouv.qc.ca
Sophie Turpin, MD
- Recruiting
CIUSSS de l'Estrie-CHUS Hospital
Sherbrooke, Quebec, J1H 5N4
Etienne Croteau, PhD, 819-346-1110 ext. 11894, etienne.croteau.ciussse-chus@ssss.gouv.qc.ca
Amelie Tetu, MSc, 819-346-1110 ext. 15571, amelie.tetu.ciussse-chus@ssss.gouv.qc.ca
About this study
Official title: Pilot Study of 68Ga-DOTATATE PET/CT and 123I-MIBG Scintigraphy Imaging of Neuroblastoma
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.
Read the detailed description
Background: Neuroblastoma is the most frequent extracranial childhood tumor, with an annual incidence of approximately 10.2 per million children. Initial staging of the disease and monitoring of the treatment response can be performed with different imaging modalities that include contrast-enhanced computed tomography (ceCT), ultrasound, magnetic resonance imaging (MRI), bone scintigraphy and 123I-MIBG scintigraphy.
Another potential target for neuroblastoma imaging is the somatostatin receptor (SSTR) that is present in many neuroendocrine tumours (NET). The superior PET imaging technology used with new radiotracers (such as 68Ga-DOTATATE) enables imaging at advantageous resolutions well below what is possible by current clinical SPECT systems that are used for 123I-MIBG.
Design: Prospective single-arm non-randomized clinical trial (phase II) - pilot
Objective: 1) Assess the feasibility and safety of 68Ga-DOTATATE PET/CT imaging in patients with neuroblastoma or suspected of having neuroblastoma. 2) Compare lesion-by-lesion the uptake of 68Ga-DOTATATE and 123I-MIBG in the same participant.
Study population: Children and adults with biopsy-proven or suspected neuroblastoma
Procedure and Follow-up: Few days after 123I-MIBG scan, participants will undergo a 68Ga-DOTA-cTATE PET/CT scan (duration 2 hours). Clinical data will be collected from this imaging and from the participant's medical record (demographic, treatment, medication, pathology, lab test results) for a 2-year follow-up period.
- Conditions
- Neuroblastoma
- Being tested
- Radiopharmaceutical 68Ga-DOTATATE
- Keywords
- imaging, 68Ga-Dotatate, 68Ga-Octreotate, positron emission tomography (PET)
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiopharmaceutical 68Ga-DOTATATEBiological
Injection of 68Ga-DOTATATE followed by PET/CT acquisition
| Study group | Role | What they receive |
|---|---|---|
| Single arm with 68Ga-DOTATATE | Experimental | all participants will undergo a PET scan with 68Ga-DOTATATE Receives: Biological: Radiopharmaceutical 68Ga-DOTATATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual rate
Number of participants enrolled / year
Measured: 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
Measured: Up to 24 hours following injection of 68Ga-DOTATATE
Secondary outcomes (2)
Positive lesions for 68Ga-DOTATATE
SUV mean of the lesion
Measured: One hour post-injection of 68Ga-DOTATATE
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
Measured: Within one week (period between 123I-MIBG scan and 68Ga-DOTATATE scan)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start6 Dec 2021
- Primary completion15 Dec 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective pilot study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne Rousseau, MD, FRCPC, Principal investigator, CIUSSSE-CHUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559217
- Sponsor's protocol ID
- 2021-3828
- Status last verified
- May 2026
- First submitted
- 16 Sep 2020
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of 68Ga-DOTATATE PET/CT and 123I-MIBG Scintigraphy Imaging of Neuroblastoma
- ClinicalTrials.gov ID
- NCT04559217
- Acronym / sponsor ID
- 2021-3828
- Conditions
- Neuroblastoma
- Keywords
- imaging, 68Ga-Dotatate, 68Ga-Octreotate, positron emission tomography (PET)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de SherbrookeUniversity, hospital or other
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Neuroblastoma is the most frequent extracranial childhood tumor, with an annual incidence of approximately 10.2 per million children. Initial staging of the disease and monitoring of the treatment response can be performed with different imaging modalities that include contrast-enhanced computed tomography (ceCT), ultrasound, magnetic resonance imaging (MRI), bone scintigraphy and 123I-MIBG scintigraphy.
Another potential target for neuroblastoma imaging is the somatostatin receptor (SSTR) that is present in many neuroendocrine tumours (NET). The superior PET imaging technology used with new radiotracers (such as 68Ga-DOTATATE) enables imaging at advantageous resolutions well below what is possible by current clinical SPECT systems that are used for 123I-MIBG.
Design: Prospective single-arm non-randomized clinical trial (phase II) - pilot
Objective: 1) Assess the feasibility and safety of 68Ga-DOTATATE PET/CT imaging in patients with neuroblastoma or suspected of having neuroblastoma. 2) Compare lesion-by-lesion the uptake of 68Ga-DOTATATE and 123I-MIBG in the same participant.
Study population: Children and adults with biopsy-proven or suspected neuroblastoma
Procedure and Follow-up: Few days after 123I-MIBG scan, participants will undergo a 68Ga-DOTA-cTATE PET/CT scan (duration 2 hours). Clinical data will be collected from this imaging and from the participant's medical record (demographic, treatment, medication, pathology, lab test results) for a 2-year follow-up period.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective pilot study
| Arm | Type | Receives |
|---|---|---|
| Single arm with 68Ga-DOTATATE | Experimental | Biological: Radiopharmaceutical 68Ga-DOTATATEall participants will undergo a PET scan with 68Ga-DOTATATE |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiopharmaceutical 68Ga-DOTATATEInjection of 68Ga-DOTATATE followed by PET/CT acquisition | Biological | Single arm with 68Ga-DOTATATE |
Primary outcome
Accrual rate
Time frame: For the duration of the study, lasting 6 years
Number of participants enrolled / year
Rate of adverse events
Time frame: Up to 24 hours following injection of 68Ga-DOTATATE
Number of adverse events (being serious or not) associated to the intervention (injection of 68Ga-DOTATATE and PET/CT acquisition
2 secondary outcomes
Positive lesions for 68Ga-DOTATATE
Time frame: One hour post-injection of 68Ga-DOTATATE
Discordance of positive lesions for 68Ga-DOTATATE and positive lesions of 123I-MIBG
Time frame: Within one week (period between 123I-MIBG scan and 68Ga-DOTATATE scan)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Etienne Rousseau, MD, FRCPC principal investigator
CIUSSSE-CHUS
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiopharmaceutical 68Ga-DOTATATE in people with Neuroblastoma, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amelie Tetu, MSc (819-346-1110 ext. 15571, amelie.tetu.ciussse-chus@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accrual rate (time frame: For the duration of the study, lasting 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.