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Digestive System Neuroendocrine TumorPhase 1NCT07150546

Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors.

A Phase 1 study testing Stereotactic Body Radiation Therapy, Lutetium Lu 177 Dotatate and Computed Tomography in people with Digestive System Neuroendocrine Tumor and Unresectable Digestive System Neuroendocrine Neoplasm, run by Emory University at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Stereotactic Body Radiation Therapy, Lutetium Lu 177 Dotatate and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesUnited States
Study dates
14 Oct 2025to 30 Sep 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 16Show fewer
  • 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)

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Pretesh Patel, MD contact

404-778-3473

pretesh.patel@emory.edu

United States2 sites, 2 recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Lisa Metzger, lisa.metzger@emory.edu

    Pretesh Patel, MD

    Recruiting

  • Emory University Hospital

    Atlanta, Georgia, 30322

    Lisa Metzger, lisa.metzger@emory.edu

    Pretesh Patel, MD

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the rate of acute grade 3+ non-hematologic toxicity of PRRT after external radiation compared to historical control of PRRT alone.

SECONDARY OBJECTIVES:

  1. To determine the rate of acute grade 2+ toxicity compared to historical control of PRRT alone.

II. To determine response rate of both large and small lesions at 3 months following treatment.

III. To determine progression free survival. IV. To describe patient-reported outcomes (PROs) of toxicity.

OUTLINE:

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 standard of care (SOC) lutetium-177 DOTATATE (177Lu-DOTATATE) intravenously (IV) once every 8 weeks for 4 doses in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the trial and undergo gallium Ga 68-DOTATATE positron emission tomography (PET)/CT before treatment.

After completion of study treatment, patients are followed up at 90 days and then every 3 months for 12 months.

Being tested
Stereotactic Body Radiation Therapy, Lutetium Lu 177 Dotatate, Computed Tomography, Magnetic Resonance Imaging, Gallium Ga 68-DOTATATE
Medical subject headings
Gastro-enteropancreatic neuroendocrine tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic Body Radiation TherapyRadiation

    Also called SABR, SBRT, SBRT, Stereotactic Ablative Body Radiation Therapy, stereotactic body radiation therapy

    Undergo SBRT

  • Lutetium Lu 177 DotatateDrug

    Also called 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

    Given IV

  • Computed TomographyProcedure or surgery

    Also called 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

    Undergo CT and PET/CT

  • Magnetic Resonance ImagingProcedure or surgery

    Also called 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

    Undergo MRI

  • Gallium Ga 68-DOTATATERadiation

    Also called (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

    Undergo gallium Ga 68-DOTATATE PET/CT

  • Positron Emission TomographyProcedure or surgery

    Also called 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

    Undergo PET/CT

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT07150546
Study groupRoleWhat they receive
Treatment (SBRT, 177Lu-DOTATATE)ExperimentalPatients 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.
Receives: Radiation: Stereotactic Body Radiation Therapy; Drug: Lutetium Lu 177 Dotatate; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Radiation: Gallium Ga 68-DOTATATE; Procedure: Positron Emission Tomography; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within 3 months of therapy

Secondary outcomes (4)

  1. Incidence of Acute Grade 2+ Non-Hematologic Adverse Events

    Non-hematologic acute grade 2+ treatment related adverse events will be summarized descriptively using frequencies and percentages of all captured toxicities by severity and relevance.

    Measured: Up to 12 months

  2. Response Rate

    The response rate based on Response Evaluation Criteria in Solid Tumors criteria of both large and small lesions at 3 months following treatment will be calculated along with 95% exact confidence intervals.

    Measured: At 3 months

  3. Progression Free Survival

    Progression free survival at 12 months will be estimated with the Kaplan-Meier method along with 95% confidence intervals.

    Measured: At 12 months

  4. Patient-Reported Health-Related Quality of Life

    Patient reported outcome will be summarized as mean, median, first quartile, third quartile, and standard deviation.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2025
  2. Study start14 Oct 2025
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Pilot study
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07150546
Sponsor's protocol ID
STUDY00008681
Other IDs
P30CA138292, NCI-2025-05882, STUDY00008681, RAD6422-24
Status last verified
Feb 2026
First submitted
25 Aug 2025
Last updated
2 Mar 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Stereotactic Body Radiation Therapy, Lutetium Lu 177 Dotatate and Computed Tomography in people with Digestive System Neuroendocrine Tumor and Unresectable Digestive System Neuroendocrine Neoplasm, run by Emory University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pretesh Patel, MD (404-778-3473, pretesh.patel@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Acute Grade 3+ Non-Hematologic Adverse Events (time frame: Within 3 months of therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07150546.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.

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