NCT03335670

Gallium 68 Pentixafor in Patients With Neuroendocrine Tumors

Biodistribution of Ga-68 Pentixafor in Patients With Neuroendocrine Tumors

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Yusuf Menda · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate how Gallium-68 Pentixafor is distributed in neuroendocrine tumor patients and if that distribution is consistent through repeated scans. This is an RDRC study - as such, the images obtained for this study cannot be used clinically or shared with treating oncologists.

Detailed description

High grade neuroendocrine tumors often do not express somatostatin (sstr) receptors but often express the CXCR4 receptor. The CXCR4 receptor is a marker of poorly differentiated cells. Pentixafor is a peptide that targets these CXCR4 receptors. By combining it with gallium-68, a radionuclide, pentixafor can then be evaluated as an imaging agent to detect high-grade neuroendocrine tumors. \[68Ga\]Pentixafor is a radio-labelled imaging agent used for positron emission tomography (PET). The dose is small, known as a tracer dose. It is designed to capture information about the body and how the body is working without interfering or causing an effect. The goal of this study is to evaluate how the \[68Ga\]Pentixafor is distributed through the body after injection and how it is taken up by the organs of the body. The study will also examine if the imaging is reproducible to determine if the PET images show the same uptake of the study drug across different scans. This study is an RDRC study - the equivalent to a phase 0 study. The \[68Ga\]Pentixafor has not been shown to target tumors; specificity and sensitivity have not been established. For this reason, images obtained for this study cannot be used clinically or shared with treating oncologists.

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	[68Ga]Pentixafor	68Ga Pentixafor is a radiolabeled cyclic pentapeptide with high affinity for CXCR4 receptor

Timeline

• Start date: 2017-11-03
• Primary completion: 2029-12-31
• Completion: 2030-06-30
• First posted: 2017-11-08
• Last updated: 2025-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study