RecruitingPhase 1NCT07150546

Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors.

Combination External Radiation and 177Lu-DOTATATE for Large Gastrointestinal Neuroendocrine Tumors: A Single Arm Pilot Clinical Trial


Sponsor

Emory University

Enrollment

15 participants

Start Date

Oct 14, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of external radiation therapy and a targeted radioactive treatment called PRRT (peptide receptor radionuclide therapy) for patients with large gastrointestinal neuroendocrine tumors (NETs) — slow-growing but difficult-to-treat cancers of the digestive tract. **You may be eligible if...** - You are 18 years old or older - You have a confirmed well-differentiated (grade 1 or 2) neuroendocrine tumor in the GI tract that cannot be surgically removed - Your cancer has progressed after one or two prior lines of treatment - Your tumor is positive on a DOTATATE PET/CT scan (a specialized scan for NETs) - You have at least one large tumor (3 cm or more) - Your kidney function is adequate (GFR above 30 mL/min) - Your overall health status is reasonable (ECOG 0–2) **You may NOT be eligible if...** - Your tumor is high-grade (grade 3) or not well-differentiated - You have poor kidney function - Your tumor is not visible on a DOTATATE PET scan Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic Body Radiation Therapy

Undergo SBRT

DRUGLutetium Lu 177 Dotatate

Given IV

PROCEDUREComputed Tomography

Undergo CT and PET/CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

RADIATIONGallium Ga 68-DOTATATE

Undergo gallium Ga 68-DOTATATE PET/CT

PROCEDUREPositron Emission Tomography

Undergo PET/CT

OTHERQuestionnaire Administration

Ancillary studies


Locations(2)

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

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NCT07150546


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