NCT07150546

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
17mo left

Started Oct 2025

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Oct 2025Sep 2027

First Submitted

Initial submission to the registry

August 25, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 2, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 14, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

12 months

First QC Date

August 25, 2025

Last Update Submit

February 27, 2026

Conditions

Digestive System Neuroendocrine TumorUnresectable Digestive System Neuroendocrine NeoplasmUnresectable Digestive System Neuroendocrine Tumor G1Unresectable Digestive System Neuroendocrine Tumor G2

Outcome Measures

Primary Outcomes (1)

  • Incidence of Acute Grade 3+ Non-Hematologic Adverse Events

    Will evaluate acute grade 3+ non-hematologic toxicity (based on Common Terminology Criteria for Adverse Events version 5) compared to historical controls of peptide receptor radionuclide therapy alone. The list of non-hematologic acute grade 3+ treatment related adverse events will be summarized descriptively using frequencies and percentages of all captured toxicities by severity and relevance. An exact binomial test will then be used to compare the observed toxicity rate to the historical control rate, assessing if the observed rate significantly exceeds expected levels.

    Within 3 months of therapy

Secondary Outcomes (4)

  • Incidence of Acute Grade 2+ Non-Hematologic Adverse Events

    Up to 12 months

  • Response Rate

    At 3 months

  • Progression Free Survival

    At 12 months

  • Patient-Reported Health-Related Quality of Life

    Up to 12 months

Study Arms (1)

Treatment (SBRT, 177Lu-DOTATATE)

EXPERIMENTAL

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.

Radiation: Stereotactic Body Radiation TherapyDrug: Lutetium Lu 177 DotatateProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingRadiation: Gallium Ga 68-DOTATATEProcedure: Positron Emission TomographyOther: Questionnaire Administration

Interventions

Lutetium Lu 177 DotatateDRUG

Given IV

Also known as: 177 Lu-DOTA-TATE, 177 Lu-DOTA-Tyr3-Octreotate, 177Lu-DOTA0-Tyr3-Octreotate, 437608-50-9, Lutathera, Lutetium (177Lu) Oxodotreotide, 177 Lu-DOTA-TATE, 177 Lu-DOTA-Tyr3-Octreotate, 177Lu-DOTA0-Tyr3-Octreotate, Lutathera, Lutetium (177Lu) Oxodotreotide, Lutetium Lu 177 DOTA(0)-Tyr(3)-Octreotate, Lutetium Lu 177 Dotatate, Lutetium Lu 177-DOTA-Tyr3-Octreotate,Lutetium Oxodotreotide Lu-177
Treatment (SBRT, 177Lu-DOTATATE)
Computed TomographyPROCEDURE

Undergo CT and PET/CT

Also known as: CAT, CAT Scan, CAT scan, CAT Scan, Computed Axial Tomography, Computed Tomography, Computed Tomography, Computed Tomography, computed tomography, Computed Tomography, computerized axial tomography,, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, computerized tomography, Computerized Tomography,, Computerized Tomography (CT) scan, CT, CT, CT, CT, CT SCAN, CT Scan, CT scan, CT Scan, CT Scan, CT Scan, CT Scan, tomography
Treatment (SBRT, 177Lu-DOTATATE)
Magnetic Resonance ImagingPROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR,MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI
Treatment (SBRT, 177Lu-DOTATATE)
Gallium Ga 68-DOTATATERADIATION

Undergo gallium Ga 68-DOTATATE PET/CT

Also known as: (68)Ga-DOTA-TATE, 1027785-90-5, 68Ga-DOTA-0-Tyr3-Octreotate, 68Ga-DOTATATE, Gallium Ga 68 Oxodotreotide, GALLIUM OXODOTREOTIDE GA-68, Gallium-68 DOTA-DPhe1, Tyr3-octreotate
Treatment (SBRT, 177Lu-DOTATATE)
Positron Emission TomographyPROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET, Pet Scan, PET SCAN, PET scan, PET Scan, PET Scan, PET Scan, Positron Emission Tomography, Positron Emission Tomography,, Positron emission tomography (procedure), positron emission tomography scan, Positron Emission Tomography Scan, Positron-Emission Tomography, PT
Treatment (SBRT, 177Lu-DOTATATE)
Questionnaire AdministrationOTHER

Ancillary studies

Treatment (SBRT, 177Lu-DOTATATE)
Stereotactic Body Radiation TherapyRADIATION

Undergo SBRT

Also known as: SABR, SBRT, SBRT, Stereotactic Ablative Body Radiation Therapy, stereotactic body radiation therapy
Treatment (SBRT, 177Lu-DOTATATE)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • +1 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Gastro-enteropancreatic neuroendocrine tumor

Interventions

Radiosurgerylutetium Lu 177 dotatateLutetiumLutetium-177copper dotatate CU-64Magnetic Resonance SpectroscopyX-RaysGa(III)-DOTATOCgallium Ga 68 dotatate2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative TechniquesLanthanoid Series ElementsMetals, Rare EarthElementsInorganic ChemicalsTransition ElementsMetalsSpectrum AnalysisChemistry Techniques, AnalyticalElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Pretesh Patel, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pretesh Patel, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Pilot study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 25, 2025

First Posted

September 2, 2025

Study Start

October 14, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2027

Last Updated

March 2, 2026

Record last verified: 2026-02

Locations

US(2)