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Radiopharmaceutical

[68Ga]Pentixafor for Neuroendocrine Cancer

Phase < 1
Waitlist Available
Led By Yusuf Menda, MD
Research Sponsored by Yusuf Menda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
Histological diagnosis of neuroendocrine tumor (NET)
Must not have
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring hospitalization, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Physical limitation that would limit compliance with the study requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 month of the second [68ga]pentixafor scan
Awards & highlights

Summary

This trial will study how a Gallium-68 Pentixafor is distributed in neuroendocrine tumor patients and if that distribution is consistent through repeated scans.

Who is the study for?
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.Check my eligibility
What is being tested?
[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.See study design
What are the potential side effects?
Since this trial focuses on imaging rather than drug effects, side effects are not a primary concern. However, typical risks associated with PET/CT scans may include discomfort from lying still and exposure to low levels of radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with a neuroendocrine tumor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
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I have a physical condition that may prevent me from following the study's requirements.
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I am not planning to receive any NET therapy except for Somatostatin analog between two specific scans.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 month of [68ga]pentixafor scan
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 month of [68ga]pentixafor scan for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine biodistribution (pharmacokinetic parameters) of [68Ga]Pentixafor in patients with neuroendocrine tumors (NETs)
Determine the repeatability of [68Ga]Pentixafor uptake in known neuroendocrine tumor lesions
Secondary outcome measures
Compare standardized uptake values of [68Ga]Pentixafor and [68Ga]DOTATATE in known neuroendocrine tumor lesions
Correlate the uptake of [68Ga]Pentixafor and [68Ga]DOTATATE (NetSpot) in known neuroendocrine tumor lesions with expression of receptors (CXCR4 and SSTR2) in biopsy tissue samples.

Trial Design

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Neuroendocrine Tumors (NETs) include somatostatin analogs, peptide receptor radionuclide therapy (PRRT), and molecularly targeted therapies. Somatostatin analogs, such as octreotide and lanreotide, bind to somatostatin receptors on tumor cells, inhibiting hormone secretion and tumor growth. PRRT uses radiolabeled somatostatin analogs to deliver targeted radiation to NET cells, reducing tumor size and progression. Molecularly targeted therapies like everolimus inhibit the mTOR pathway, which is involved in cell growth and proliferation. These treatments are crucial for NET patients as they offer targeted approaches to control tumor growth and manage symptoms. Imaging agents like Gallium-68 Pentixafor, which binds to CXCR4 receptors, are important for accurately diagnosing and monitoring the disease, ensuring that patients receive the most effective treatment.
Systemic therapy for pulmonary carcinoids.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,371 Total Patients Enrolled
80 Trials studying Neuroendocrine Tumors
43,568 Patients Enrolled for Neuroendocrine Tumors
Holden Comprehensive Cancer CenterOTHER
26 Previous Clinical Trials
747 Total Patients Enrolled
5 Trials studying Neuroendocrine Tumors
87 Patients Enrolled for Neuroendocrine Tumors
National Institutes of Health (NIH)NIH
2,736 Previous Clinical Trials
7,507,920 Total Patients Enrolled
7 Trials studying Neuroendocrine Tumors
122 Patients Enrolled for Neuroendocrine Tumors

Media Library

Gallium-68 Pentixafor (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT03335670 — Phase < 1
Neuroendocrine Tumors Research Study Groups: [68Ga]Pentixafor PET scan
Neuroendocrine Tumors Clinical Trial 2023: Gallium-68 Pentixafor Highlights & Side Effects. Trial Name: NCT03335670 — Phase < 1
Gallium-68 Pentixafor (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03335670 — Phase < 1
~8 spots leftby Dec 2026