[68Ga]Pentixafor for Neuroendocrine Cancer

Recruiting in Palo Alto (17 mi)

Yusuf Menda | University of Iowa Health ...

Overseen byM. Sue O'Dorisio, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Yusuf Menda

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial uses Gallium-68 Pentixafor, an imaging agent for PET scans, to detect high-grade neuroendocrine tumors. It targets specific markers on these tumors and makes them visible on scans. The study aims to see how consistently this agent works across different scans.

Eligibility Criteria

Adults over 18 with a confirmed neuroendocrine tumor, registered in the Iowa Neuroendocrine Tumor Registry, who've had specific scans within the last 3 months without significant treatment changes. Excludes pregnant women, those planning NET therapy between scans (except for Somatostatin analog), and anyone with illnesses or conditions that could interfere with study participation.

Inclusion Criteria

Results of CXCR4 immunohistochemistry or slides from biopsy of primary tumor or metastatic lesions available for study analysis

Participation in the Iowa Neuroendocrine Tumor Registry

I have a tumor larger than 1.5 cm, confirmed by CT or MRI in the last 3 months.

+3 more

Exclusion Criteria

Pregnant or lactating women. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A negative pregnancy test will be required for all female subjects with child bearing potential

I am not planning to receive any NET therapy except for Somatostatin analog between two specific scans.

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

+1 more

Participant Groups

[68Ga]Pentixafor's distribution in patients' bodies is being tested to see if it's consistent across multiple scans. This research doesn't apply clinically; images can't be used for medical decisions or shared with oncologists.

1Treatment groups

Experimental Treatment

Group I: [68Ga]Pentixafor PET scanExperimental Treatment1 Intervention

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.