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RECRUITING
NCT07150546
PHASE1

Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors.

Sponsor: Emory University

View on ClinicalTrials.gov

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

Interventions

RADIATION

Stereotactic Body Radiation Therapy

Undergo SBRT

DRUG

Lutetium Lu 177 Dotatate

Given IV

PROCEDURE

Computed Tomography

Undergo CT and PET/CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

RADIATION

Gallium Ga 68-DOTATATE

Undergo gallium Ga 68-DOTATATE PET/CT

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

OTHER

Questionnaire Administration

Ancillary studies

Locations (2)

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States