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4 mCi (range 3-5 mCi) of \[68Ga\]Pentixafor is administered intravenously over 1 minute using an infusion pump. PET imaging is performed from time of infusion for about 90 minutes. Approximately 12 blood samples (\~ 1 tsp) will be taken for pharmacokinetic analysis.

68Ga Pentixafor is a radiolabeled cyclic pentapeptide with high affinity for CXCR4 receptor

[68Ga]Pentixafor

Yusuf Menda, MD

M. Sue O'Dorisio, MD, PhD

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.

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.

Gallium 68 Pentixafor in Patients With Neuroendocrine Tumors

Biodistribution of Ga-68 Pentixafor in Patients With Neuroendocrine Tumors

Individual participant data will be shared upon request to the study's principal investigator. A signed usage agreement will need to be provided.

Biodistribution will be assessed through the radiotracer parameters standardized uptake value (SUV) and K-influx obtained from PET scan and blood samples.These values provide a pharmacokinetic profile of the investigational drug's biodistribution in the body.

Determine the difference, in any, of the biodistribution values between scans 1 and 2, for subjects who undergo 2 \[68Ga\]Pentixafor scans.

The standardized uptake value (SUV) of known neuroendocrine tumors for the investigational agent \[68Ga\]Pentixafor will be compared to the SUV for \[68Ga\]DOTATATE (NetSpot).

The standardized uptake value (SUV) of the gallium PET tracers ( \[68Ga\]Pentixafor and/or \[68Ga\]DOTATATE) will be compared to the receptor expression score (H-score)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Gallium 68 Pentixafor in Patients With Neuroendocrine Tumors	NCT03335670	Neuroendocrine ...	[68Ga]Pentixafo...	18 Years -	University of Iowa
Gallium 68 Pentixafor in Patients With Neuroendocrine Tumors	NCT03335670	Neuroendocrine ...	[68Ga]Pentixafo...	18 Years -	University of Iowa

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