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Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors.
Sponsor: Emory University
Summary
This phase I trial tests the safety and effectiveness of stereotactic body radiation therapy (SBRT) followed by 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) in treating patients with large well-differentiated grade 1-2 digestive system neuroendocrine tumors that cannot be removed by surgery (unresectable). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body. The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. 177Lu-DOTATATE is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. 177Lu-DOTATATE builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. Giving PRRT after SBRT may reduce the chances of the disease returning or getting worse, compared to the standard treatment of PRRT alone.
Official title: Combination External Radiation and 177Lu-DOTATATE for Large Gastrointestinal Neuroendocrine Tumors: A Single Arm Pilot Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2025-10-14
Completion Date
2027-09-30
Last Updated
2026-03-02
Healthy Volunteers
No
Conditions
Interventions
Stereotactic Body Radiation Therapy
Undergo SBRT
Lutetium Lu 177 Dotatate
Given IV
Computed Tomography
Undergo CT and PET/CT
Magnetic Resonance Imaging
Undergo MRI
Gallium Ga 68-DOTATATE
Undergo gallium Ga 68-DOTATATE PET/CT
Positron Emission Tomography
Undergo PET/CT
Questionnaire Administration
Ancillary studies
Locations (2)
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States