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Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors.

NCT07150546 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-03-02

No results posted yet for this study

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.

Conditions

  • Digestive System Neuroendocrine Tumor
  • Unresectable Digestive System Neuroendocrine Neoplasm
  • Unresectable Digestive System Neuroendocrine Tumor G1
  • Unresectable Digestive System Neuroendocrine Tumor G2

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Pretesh Patel, MD · Emory University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-14
Primary Completion
2026-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07150546 on ClinicalTrials.gov