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Combination Radiation and PRRT for Large GI Neuroendocrine Tumors

This study is testing a combination of treatments for large digestive system neuroendocrine tumors that cannot be removed by surgery (unresectable). You would first receive Stereotactic Body Radiation Therapy (SBRT), a type of focused radiation. This is followed by Lutetium Lu 177 Dotatate, a radioactive drug that targets specific tumor cells. Researchers want to see how safe this combination is by looking at serious side effects within three months of therapy. They also want to understand how well the treatment shrinks tumors and how long patients live without their disease getting worse. This study is for adults aged 18 and older with well-differentiated, grade 1-2 neuroendocrine tumors that have progressed after previous treatments. The study plans to enroll 15 participants.

Study design
This is an interventional study, meaning you will receive specific treatments. It plans to enroll 15 participants.
What's involved
You would undergo SBRT, followed by Lutetium Lu 177 Dotatate given intravenously every 8 weeks for 4 doses. You will also have CT, MRI, and PET/CT scans throughout the trial.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you will have follow-up visits at 90 days and then every 3 months for 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07150546

Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors.

Recruiting
PHASE1Ages 18+InterventionalTreatment
Emory University
~15 participants
Updated 2026-03-02 on ClinicalTrials.gov
What's tested:Stereotactic Body Radiation TherapyLutetium Lu 177 DotatateComputed TomographyMagnetic Resonance ImagingGallium Ga 68-DOTATATEPositron Emission Tomography

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Acute Grade 3+ Non-Hematologic Adverse Events
Measured over Within 3 months of therapy

Conditions

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

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Digestive System Neuroendocrine TumorSomatostatin Receptor

Where it's being run

2 sites across 1 states
Georgia2

Study leadership

  • Pretesh Patel, MD · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

Pretesh Patel, MD
[email protected]
404-778-3473
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of Acute Grade 3+ Non-Hematologic Adverse EventsWithin 3 months of therapy

    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.