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NCT07150546 · ClinicalTrials.gov registry record · Phase 1
Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors.
A Phase 1 study of Digestive System Neuroendocrine Tumor and Unresectable Digestive System Neuroendocrine Tumor G1, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 2
- Study locations
NCT07150546: Recruiting Phase 1 study of Digestive System Neuroendocrine Tumor and Unresectable Digestive System Neuroendocrine Tumor G1, sponsored by Emory University.
NCT07150546 is a Phase 1 study of Digestive System Neuroendocrine Tumor and Unresectable Digestive System Neuroendocrine Tumor G1 that is actively recruiting participants, run by Emory University. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07150546, a Phase 1 study of Digestive System Neuroendocrine Tumor and Unresectable Digestive System Neuroendocrine Tumor G1, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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 cont
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- RADIATION Stereotactic Body Radiation Therapy
- RADIATION Gallium Ga 68-DOTATATE
- DRUG Lutetium Lu 177 Dotatate
Study Locations (2)
Georgia
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-10-14 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 1 |
What NCT07150546 shows while recruiting
NCT07150546 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 4 conditions, with Digestive System Neuroendocrine Tumor appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT07150546 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT07150546 about?
NCT07150546 is a clinical study titled "Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors.". 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 s...
What is the current status of trial NCT07150546?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2025-10-14. Estimated completion is 2027-09-30.
What conditions does trial NCT07150546 study?
This clinical trial studies the following conditions: Digestive System Neuroendocrine Tumor, Unresectable Digestive System Neuroendocrine Tumor G1, Unresectable Digestive System Neuroendocrine Tumor G2, Unresectable Digestive System Neuroendocrine Neoplasm.
What interventions are being tested in trial NCT07150546?
The interventions under investigation include: Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Stereotactic Body Radiation Therapy (RADIATION), Gallium Ga 68-DOTATATE (RADIATION), Lutetium Lu 177 Dotatate (DRUG).
Who is sponsoring clinical trial NCT07150546?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07150546 being conducted?
This trial has 2 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07150546's enrollment target sits among peer trials
15 1799th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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