Utility of Gallium-68-DOTA-Octreotate PET/CT in the Characterization of Pediatric Neuroendocrine Tumors
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- STATUS
- Recruiting
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- End date
- Jul 10, 2023
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- participants needed
- 20
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- sponsor
- Mayo Clinic
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.
Description
PRIMARY OBJECTIVE:
I. 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:
I. 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 every 3 months for up to 2 years.
Details
| Condition | Ganglioneuroblastoma, Ganglioneuroma, Neuroblastoma |
|---|---|
| Treatment | computed tomography, positron emission tomography, Gallium Ga 68-DOTATATE |
| Clinical Study Identifier | NCT04040088 |
| Sponsor | Mayo Clinic |
| Last Modified on | 25 October 2022 |
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