GanglioneuroblastomaEarly Phase 1NCT04040088
An Investigational Scan (68Ga-DOTATATE PET/CT) in Diagnosing Pediatric Metastatic Neuroendocrine Tumors
A Early Phase 1 study testing Computed Tomography, Gallium Ga 68-DOTATATE and Positron Emission Tomography in people with Ganglioneuroblastoma and Ganglioneuroma, run by Mayo Clinic at 1 site in United States.
Trial summary
This trial studies how well an investigational scan called 68Ga-DOTATATE PET/CT works in diagnosing pediatric patients with neuroendocrine tumors that have spread to other places in the body (metastatic). Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Ganglioneuroblastoma, Ganglioneuroma, Neuroblastoma
- What is being tested?
- Computed Tomography, Gallium Ga 68-DOTATATE and Positron Emission Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2019to 31 Jul 2026
- Phase
- Early Phase 1
- 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 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age =< 30 years
- Histological confirmation of neuroblastoma, ganglioneuroblastoma, or ganglioneuroma.
- High-risk neuroblastoma requiring consolidative RT, as determined by the treating radiation oncologist.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3 (patients 16 years old or older at entry) or Lansky Score of 30-100 (patients <16 years old at entry).
- Planned for radiation planning and RT at enrolling institution.
- Documented negative pregnancy test prior to induction chemotherapy, for women of childbearing age within =< 7 days prior to registration.
- Willing to return to enrolling institution for follow-up imaging and clinical evaluation, or willing to send follow-up imaging and clinical notes to enrolling institution (during the observation phase of the study).
Who cannot join
- Pregnant women, nursing women who refuse to stop breastfeeding, or men/women of childbearing age who are unwilling to use an effective birth control method.
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
- Immunocompromised patients and patients known to be human immunodeficiency virus positive and currently receiving antiretroviral therapy. NOTE: Patients known to be human immunodeficiency virus positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Utility of Gallium-68-DOTA-Octreotate PET/CT in the Characterization of Pediatric Neuroendocrine Tumors
This trial studies how well an investigational scan called 68Ga-DOTATATE PET/CT works in diagnosing pediatric patients with neuroendocrine tumors that have spread to other places in the body (metastatic). A neuroendocrine tumor is an abnormal growth of neuroendocrine cells, which are cells resembling nerve cells and hormone-producing cells. 68Ga-DOTATATE is a radioactive substance called a radiotracer that when used with PET/CT scans, may work better than standard of care MIBG scans in diagnosing pediatric metastatic neuroendocrine tumors and targeting them with radiation therapy.
Read the detailed description
PRIMARY OBJECTIVE:
- To estimate the difference in radiation therapy (RT) target volume definition between gallium Ga 68-DOTATATE (68Ga-DOTATATE) PET/CT and iobenguane (metaiodobenzylguanidine [MIBG]).
SECONDARY OBJECTIVES:
- To estimate the difference in metastatic tumor burden as detected by 68Ga-DOTATATE PET/CT and MIBG.
II. To estimate the difference in metabolic activity between tumors diagnosed on 68Ga-DOTATATE PET/CT and MIBG.
III. To evaluate patterns of failure after RT in association with 68Ga-DOTATATE PET/CT and MIBG.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT A: Patients with newly diagnosed high-risk neuroendocrine cancer receive 68Ga-DOTATATE intravenously (IV) and undergo PET/CT over 20-30 minutes at diagnosis (before any treatment) and at the time of radiation treatment planning.
COHORT B: Patients with previously diagnosed high-risk neuroendocrine cancer receive 68Ga-DOTATATE IV and undergo PET/CT over 20-30 minutes at the time of radiation treatment planning.
After completion of study, patients are followed up per standard of care for up to 2 years.
- Conditions
- Ganglioneuroblastoma, Ganglioneuroma, Neuroblastoma
- Being tested
- Computed Tomography, Gallium Ga 68-DOTATATE, Positron Emission Tomography
- Medical subject headings
- Ganglioneuroblastoma, Ganglioneuroma, Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo PET/CT
Gallium Ga 68-DOTATATEDrug
Also called (68)Ga-DOTA-TATE, 68Ga-DOTA-0-Tyr3-Octreotate, 68Ga-DOTATATE, Gallium Ga 68 Oxodotreotide
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (68Ga-DOTATATE, PET/CT) | Experimental | Patients with newly diagnosed high-risk neuroendocrine cancer receive 68Ga-DOTATATE intravenously (IV) and undergo PET/CT over 20-30 minutes at diagnosis (before any treatment) and at the time of radiation treatment planning. Receives: Procedure: Computed Tomography; Drug: Gallium Ga 68-DOTATATE; Procedure: Positron Emission Tomography |
| Cohort B (68Ga-DOTATATE, PET/CT) | Experimental | Patients with previously diagnosed high-risk neuroendocrine cancer receive 68Ga-DOTATATE IV and undergo PET/CT over 20-30 minutes at the time of radiation treatment planning. Receives: Procedure: Computed Tomography; Drug: Gallium Ga 68-DOTATATE; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in radiation treatment target volume definition between 68Ga-DOTATATE positron emission tomography/computed tomography (PET/CT) and iobenguane (MIBG)
Will analyze the data descriptively in lieu of hypothesis testing. However, each metastatic lesion will be analyzed independently. Will report the mean and standard deviation of the difference between target tumor volumes. For patients with more than one metastasis, will compute the difference in the sum of the target volumes for all metastases.
Measured: From baseline to the time of radiation treatment planning (up to 3 months)
Secondary outcomes (3)
Proportion of agreement between MIBG and 68Ga-DOTATATE PET/CT in identifying neuroendocrine tumors
Will calculate the proportion of metastatic tumors detected by MIBG that are also detected by 68Ga-DOTATATE PET/CT. Each metastatic lesion will be considered an independent data point. A 95% confidence interval will be included using the Clopper-Pearson method.
Measured: At diagnosis and during the radiation treatment (RT) planning period (up to 3 months)
Tumor metabolic activity of 68Ga-DOTATATE PET/CT compared to MIBG
Will perform some descriptive analyses to note the differences between MIBG and 68Ga-DOTATATE PET/CT. This may include measuring the difference in the number of metastatic sites per patient. Each metastatic lesion will be considered an independent data point.
Measured: At diagnosis and during the RT planning period (up to 3 months)
Patterns of failure after RT
Will evaluate patterns of failure after RT and associate with MIBG and 68Ga-DOTATATE PET/CT using two-year relapse rates. Relapse is defined as an increase in treated lesion(s) and/or new tumor per the progressive disease category of the International Neuroblastoma Response Criteria. Two-year cumulative incidence of relapse from first day of RT for the four categories listed above will be calculated considering death as a competing risk. Each relapse site will be considered an independent event.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start23 Sep 2019
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GanglioneuroblastomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia Laack, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040088
- Sponsor's protocol ID
- MC1872
- Other IDs
- 16-010137
- Status last verified
- Mar 2026
- First submitted
- 19 Jul 2019
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Gallium-68-DOTA-Octreotate PET/CT in the Characterization of Pediatric Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT04040088
- Acronym / sponsor ID
- MC1872
- Conditions
- Ganglioneuroblastoma, Ganglioneuroma, Neuroblastoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 31 Jul 2019 (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.
This trial studies how well an investigational scan called 68Ga-DOTATATE PET/CT works in diagnosing pediatric patients with neuroendocrine tumors that have spread to other places in the body (metastatic). A neuroendocrine tumor is an abnormal growth of neuroendocrine cells, which are cells resembling nerve cells and hormone-producing cells. 68Ga-DOTATATE is a radioactive substance called a radiotracer that when used with PET/CT scans, may work better than standard of care MIBG scans in diagnosing pediatric metastatic neuroendocrine tumors and targeting them with radiation therapy.
Detailed description
PRIMARY OBJECTIVE:
- To estimate the difference in radiation therapy (RT) target volume definition between gallium Ga 68-DOTATATE (68Ga-DOTATATE) PET/CT and iobenguane (metaiodobenzylguanidine [MIBG]).
SECONDARY OBJECTIVES:
- To estimate the difference in metastatic tumor burden as detected by 68Ga-DOTATATE PET/CT and MIBG.
II. To estimate the difference in metabolic activity between tumors diagnosed on 68Ga-DOTATATE PET/CT and MIBG.
III. To evaluate patterns of failure after RT in association with 68Ga-DOTATATE PET/CT and MIBG.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT A: Patients with newly diagnosed high-risk neuroendocrine cancer receive 68Ga-DOTATATE intravenously (IV) and undergo PET/CT over 20-30 minutes at diagnosis (before any treatment) and at the time of radiation treatment planning.
COHORT B: Patients with previously diagnosed high-risk neuroendocrine cancer receive 68Ga-DOTATATE IV and undergo PET/CT over 20-30 minutes at the time of radiation treatment planning.
After completion of study, patients are followed up per standard of care for up to 2 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A (68Ga-DOTATATE, PET/CT) | Experimental | Procedure: Computed Tomography, Drug: Gallium Ga 68-DOTATATE, Procedure: Positron Emission TomographyPatients with newly diagnosed high-risk neuroendocrine cancer receive 68Ga-DOTATATE intravenously (IV) and undergo PET/CT over 20-30 minutes at diagnosis (before any treatment) and at the time of radiation treatment planning. |
| Cohort B (68Ga-DOTATATE, PET/CT) | Experimental | Procedure: Computed Tomography, Drug: Gallium Ga 68-DOTATATE, Procedure: Positron Emission TomographyPatients with previously diagnosed high-risk neuroendocrine cancer receive 68Ga-DOTATATE IV and undergo PET/CT over 20-30 minutes at the time of radiation treatment planning. |
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age =< 30 years
- Histological confirmation of neuroblastoma, ganglioneuroblastoma, or ganglioneuroma.
- High-risk neuroblastoma requiring consolidative RT, as determined by the treating radiation oncologist.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3 (patients 16 years old or older at entry) or Lansky Score of 30-100 (patients <16 years old at entry).
- Planned for radiation planning and RT at enrolling institution.
Key exclusion criteria (3 listed)
- Pregnant women, nursing women who refuse to stop breastfeeding, or men/women of childbearing age who are unwilling to use an effective birth control method.
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
- Immunocompromised patients and patients known to be human immunodeficiency virus positive and currently receiving antiretroviral therapy. NOTE: Patients known to be human immunodeficiency virus positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
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 |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo PET/CT | Procedure or surgery | Cohort A (68Ga-DOTATATE, PET/CT), Cohort B (68Ga-DOTATATE, PET/CT) |
| Gallium Ga 68-DOTATATEAlso: (68)Ga-DOTA-TATE, 68Ga-DOTA-0-Tyr3-Octreotate, 68Ga-DOTATATE, Gallium Ga 68 OxodotreotideGiven IV | Drug | Cohort A (68Ga-DOTATATE, PET/CT), Cohort B (68Ga-DOTATATE, PET/CT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo PET/CT | Procedure or surgery | Cohort A (68Ga-DOTATATE, PET/CT), Cohort B (68Ga-DOTATATE, PET/CT) |
Primary outcome
Difference in radiation treatment target volume definition between 68Ga-DOTATATE positron emission tomography/computed tomography (PET/CT) and iobenguane (MIBG)
Time frame: From baseline to the time of radiation treatment planning (up to 3 months)
Will analyze the data descriptively in lieu of hypothesis testing. However, each metastatic lesion will be analyzed independently. Will report the mean and standard deviation of the difference between target tumor volumes. For patients with more than one metastasis, will compute the difference in the sum of the target volumes for all metastases.
3 secondary outcomes
Proportion of agreement between MIBG and 68Ga-DOTATATE PET/CT in identifying neuroendocrine tumors
Time frame: At diagnosis and during the radiation treatment (RT) planning period (up to 3 months)
Tumor metabolic activity of 68Ga-DOTATATE PET/CT compared to MIBG
Time frame: At diagnosis and during the RT planning period (up to 3 months)
Patterns of failure after RT
Time frame: Up to 2 years
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 31 Mar 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Nadia Laack, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Computed Tomography, Gallium Ga 68-DOTATATE and Positron Emission Tomography in people with Ganglioneuroblastoma and Ganglioneuroma, run by Mayo Clinic at 1 site in United States.
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 7 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in radiation treatment target volume definition between 68Ga-DOTATATE positron emission tomography/computed tomography (PET/CT) and iobenguane (MIBG) (time frame: From baseline to the time of radiation treatment planning (up to 3 months)). 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 31 Mar 2026.