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NCT06016855 · ClinicalTrials.gov registry record · Phase 4
Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors
A Phase 4 study of Metastatic Malignant Neoplasm in the Liver and Metastatic Digestive System Neuroendocrine Neoplasm, sponsored by Vanderbilt-Ingram Cancer Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT06016855: Recruiting Phase 4 study of Metastatic Malignant Neoplasm in the Liver and Metastatic Digestive System Neuroendocrine Neoplasm, sponsored by Vanderbilt-Ingram Cancer Center.
NCT06016855 is a Phase 4 study of Metastatic Malignant Neoplasm in the Liver and Metastatic Digestive System Neuroendocrine Neoplasm that is actively recruiting participants, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 6 participants, below the 92-participant average among 13 other Metastatic Malignant Neoplasm in the Liver trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06016855, a Phase 4 study of Metastatic Malignant Neoplasm in the Liver and Metastatic Digestive System Neuroendocrine Neoplasm, is actively recruiting participants, sponsored by Vanderbilt-Ingram Cancer Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase IV trial evaluates how well giving standard of care (SOC) peptide receptor radionuclide therapy (PRRT) after SOC surgical removal of as much tumor as possible (debulking surgery) works in treating patients with grade 1 or 2, somatostatin receptor (SSTR) positive, gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have spread from where they first started (primary site) to the liver (hepatic metastasis). Lutetium Lu 177 dotatate is a radioactive drug that uses targeted radiation to kill tumor cells. Lutetium Lu 177 dotatate includes a radioactive form (an isotope) of the element called lutetium. This radioactive isotope (Lu-177) is attached to a molecule called dotatate. On the surface of GEP-NET tumor cells, a receptor called a somatostatin receptor binds to dotatate. When this binding occurs, the lutetium Lu 177 dotatate drug then enters somatostatin receptor-positive tumor cells, and radiation emitted by Lu-177 helps kill the cells. Giving lutetium Lu 177 dotatate after surgical debulking may better treat patients with grade 1/2 GEP-NETs
Primary Outcome
SSTR SUV (not limited to but including measures such as SSTR SUV max, SSTR SUV mean) will be estimated for the patients undergoing post-operative research dotatate scans and compared to values from peptide receptor radionuclide therapy (PRRT) eligibility-conferring dotatate scans in these same patients. These quantitative analytics will be performed by central review. Changes in SSTR SUV values will be analyzed with summary statistics.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- DRUG Lutetium Lu 177 Dotatate
- PROCEDURE Tumor Debulking
- DRUG Copper Cu 64 Dotatate
Study Locations (1)
Tennessee
- Vanderbilt University/Ingram Cancer Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2024-05-31 |
| Est. Completion | 2028-05-28 |
| Phase | Phase 4 |
What NCT06016855 shows while recruiting
NCT06016855 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 92-participant average among 13 other Metastatic Malignant Neoplasm in the Liver trials with a reported enrollment target (93% lower).
The record links to 6 conditions, with Metastatic Malignant Neoplasm in the Liver appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT06016855 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT06016855 about?
NCT06016855 is a clinical study titled "Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors". This phase IV trial evaluates how well giving standard of care (SOC) peptide receptor radionuclide therapy (PRRT) after SOC surgical removal of as much tumor as possible (debulking surgery) works in treating patients with grade 1 or 2, somatostatin receptor (SSTR) positive, gastroenteropancreatic ne...
What is the current status of trial NCT06016855?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 6 participants. The study started on 2024-05-31. Estimated completion is 2028-05-28.
What conditions does trial NCT06016855 study?
This clinical trial studies the following conditions: Metastatic Malignant Neoplasm in the Liver, Metastatic Digestive System Neuroendocrine Neoplasm, Digestive System Neuroendocrine Tumor G1, Digestive System Neuroendocrine Tumor G2, Pancreatic Neuroendocrine Tumor G1.
What interventions are being tested in trial NCT06016855?
The interventions under investigation include: Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Lutetium Lu 177 Dotatate (DRUG), Tumor Debulking (PROCEDURE), Copper Cu 64 Dotatate (DRUG).
Who is sponsoring clinical trial NCT06016855?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06016855 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06016855's enrollment target sits among peer trials
6 14th of 13 the lowest of 13 other Metastatic Malignant Neoplasm in the Liver trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Malignant Neoplasm in the Liver 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.
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