Recruiting
Phase 1

SBRT & 177Lu-DOTATATE

Sponsor:

Emory University

Code:

NCT07150546

Conditions

Digestive System Neuroendocrine Tumor

Unresectable Digestive System Neuroendocrine Neoplasm

Unresectable Digestive System Neuroendocrine Tumor G1

Unresectable Digestive System Neuroendocrine Tumor G2

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stereotactic Body Radiation Therapy

Lutetium Lu 177 Dotatate

Computed Tomography

Magnetic Resonance Imaging

Gallium Ga 68-DOTATATE

Study Details

Brief 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

Study ID

NCT07150546

Start date

Oct 14, 2025

Status verified date

Feb, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Any prior radiation therapy including prior PRRT, external radiation, or Yttrium-90 radioembolization to the same site/region
  • Contraindications to radiation therapy including inflammatory bowel disease, systemic sclerosis, etc.
  • Brain metastases or any metastases extending into the spinal canal
  • Unable to obtain confirmation of payment coverage for any planned radiation treatment

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (SBRT, 177Lu-DOTATATE)

Patients undergo SBRT over 5 fractions in the absence of disease progression or unacceptable toxicity. Starting 4-10 weeks after completion of SBRT, patients receive SOC 177Lu-DOTATATE IV once every 8 weeks for 4 doses in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI throughout the trial and undergo gallium Ga 68-DOTATATE PET/CT before treatment.

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

Primary outcome measure

  • Incidence of Acute Grade 3+ Non-Hematologic Adverse Events [ Time Frame: Within 3 months of therapy ]

Central Contacts and Locations

Central contacts

Pretesh Patel, MD

404-778-3473pretesh.patel@emory.edu

Locations

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Lisa Metzger

lisa.metzger@emory.edu

Principal Investigator:

Pretesh Patel, MD

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Lisa Metzger

lisa.metzger@emory.edu

Principal Investigator:

Pretesh Patel, MD

More Information

Sponsor

Emory University

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-03-02.