NCT07150546RecruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 2 Mar 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 1
Study type: Interventional
Enrollment: 15 (estimated)
First submitted: 25 Aug 2025
Start date: 14 Oct 2025
Primary completion date: 30 Sept 2026
Lead sponsor: Emory University
Diseases: Neuroendocrine tumours
NCT number: NCT07150546

What you commit to

Study type: Interventional · Phase 1
Planned participants: 15
From 14 Oct 2025 to the primary completion date, 30 Sept 2026
2 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Any prior radiation therapy including prior PRRT, external radiation, or Yttrium-90 radioembolization to the same site/region
Unable to obtain confirmation of payment coverage for any planned radiation treatment

Other illness

Contraindications to radiation therapy including inflammatory bowel disease, systemic sclerosis, etc.

Other

Brain metastases or any metastases extending into the spinal canal

Who the study is looking for

Male or female
Age ≥ 18 years
Patient must be able to provide study specific informed consent
Pathologically confirmed neuroendocrine tumor fulfilling all of the following criteria
Well-differentiated, grade 1-2
Unresectable (prior resection is allowable), verified by tumor board or surgical oncology (surg onc)
Progression after one or two prior lines of systemic therapy
Somatostatin-receptor positive disease as determined by positive radiotracer-labeled DOTATATE PET/CT scan (modified Krenning score 3+)
One or more large lesions measuring 3 or more cm on contrast-enhanced CT or MRI
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Estimated glomerular filtration rate (GFR) \> 30 mL/min (within 90 days prior to study registration)
Total bilirubin ≤ 3 x upper limit of normal (within 90 days prior to study registration)
Albumin \> 30 g/L (within 90 days prior to study registration)
White blood cell (WBC) ≥ 2,000 cells/mm\^3 (within 90 days prior to study registration)
Platelets ≥ 70000 cells/mm\^3 (within 90 days prior to study registration)
Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] ≥ 8.0 g/dl is acceptable.) (within 90 days prior to study registration)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Emory University Hospital Midtown Coordinator of this site? Confirm its status	Atlanta	United States	Recruiting
Emory University Hospital Coordinator of this site? Confirm its status	Atlanta	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.