What side effects are associated with this type of intervention?

Common treatments for Neuroendocrine Tumors (NETs) include peptide receptor radionuclide therapy (PRRT) with agents like Lutetium-177 dotatate, somatostatin analogs, and various embolization techniques. PRRT can cause side effects such as nausea, vomiting, fatigue, and more serious issues like nephrotoxicity and hematologic dysfunction, including myelodysplastic syndrome and acute myeloid leukemia. Somatostatin analogs, such as octreotide and lanreotide, may lead to gastrointestinal disturbances, gallstones, and glucose metabolism alterations. Embolization techniques, including transarterial chemoembolization (TACE) and radioembolization, can result in post-embolization syndrome (fever, pain, nausea), liver dysfunction, and, in some cases, biliary injury.

What prior FDA approvals exist?

The FDA has approved several treatments for neuroendocrine tumors (NETs), particularly those involving radioligand therapy and PET imaging agents. One notable approval is Lutetium Lu 177 dotatate (Lutathera), which targets somatostatin receptors and is used for peptide receptor radionuclide therapy (PRRT) in patients with somatostatin receptor-positive gastroenteropancreatic NETs. Additionally, Everolimus (Afinitor) has been approved for the treatment of advanced NETs of gastrointestinal or lung origin. While Gallium-68 Pentixafor specifically targets CXCR4 receptors for PET imaging, similar imaging agents like Gallium-68 DOTATATE (Netspot) have been approved for detecting somatostatin receptor-positive NETs.

What other types of research exist?

Promising alternatives to Gallium-68 Pentixafor for neuroendocrine tumors include 68Ga-DOTATATE and 18F-SiFAlin-TATE. 68Ga-DOTATATE is a well-established agent targeting somatostatin receptors with high binding affinity and favorable pharmacokinetics. 18F-SiFAlin-TATE is a novel agent that has shown even higher tumor accumulation and uptake values in PET/CT imaging compared to 68Ga-DOTATATE, making it a potential superior alternative for imaging neuroendocrine tumors.

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Radiopharmaceutical

[68Ga]Pentixafor for Neuroendocrine Cancer

Q: What is the mechanism of action of this treatment?

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.

Phase < 1

Waitlist Available

Led By M. Sue O'Dorisio, MD, PhD

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

No Placebo-Only Group

Summary

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.

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.

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.

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

Select...

I am 18 years old or older.

Select...

I have been diagnosed with a neuroendocrine tumor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have a physical condition that may prevent me from following the study's requirements.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 1 month of [68ga]pentixafor scan

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met

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.