Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ganglioneuroblastoma | Ganglioneuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Ganglioneuroma | Ganglioneuroma | ONTOLOGY_EXACT | 0.98 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Procedure | — | UNRESOLVED |
| Gallium Ga 68-DOTATATE | Drug | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort A (68Ga-DOTATATE, PET/CT)
- description
- 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.
- interventionNames
- Procedure: Computed Tomography
- Drug: Gallium Ga 68-DOTATATE
- Procedure: Positron Emission Tomography
- type
- EXPERIMENTAL
- label
- Cohort B (68Ga-DOTATATE, PET/CT)
- description
- 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.
- interventionNames
- Procedure: Computed Tomography
- Drug: Gallium Ga 68-DOTATATE
- Procedure: Positron Emission Tomography
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available