An Investigational Scan (68Ga-DOTATATE PET/CT) in Diagnosing Pediatric Metastatic Neuroendocrine Tumors
Utility of Gallium-68-DOTA-Octreotate PET/CT in the Characterization of Pediatric Neuroendocrine Tumors
2 other identifiers
interventional
20
1 country
1
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Sep 2019
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2019
CompletedFirst Posted
Study publicly available on registry
July 31, 2019
CompletedStudy Start
First participant enrolled
September 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
March 31, 2026
March 1, 2026
6.9 years
July 19, 2019
March 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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
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
At diagnosis and during the RT planning period (up to 3 months)
Patterns of failure after RT
Up to 2 years
Study Arms (2)
Cohort A (68Ga-DOTATATE, PET/CT)
EXPERIMENTALPatients 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)
EXPERIMENTALPatients 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.
Interventions
Undergo PET/CT
Given IV
Undergo PET/CT
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nadia Laack, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2019
First Posted
July 31, 2019
Study Start
September 23, 2019
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
March 31, 2026
Record last verified: 2026-03