What side effects are associated with this type of intervention?

Common treatments for endocrine neoplasia include tamoxifen, aromatase inhibitors, and radiolabeled agents like octreotide. Tamoxifen can cause hot flashes, increased risk of thromboembolic events, and endometrial cancer. Aromatase inhibitors are associated with bone density loss, fractures, and cardiovascular risks. Radiolabeled octreotide can lead to hematologic and renal toxicities. These treatments aim to manage hormone levels and tumor growth but come with significant side effects that need to be carefully managed.

What prior FDA approvals exist?

FDA-approved treatments for endocrine neoplasia include various targeted therapies and imaging agents. For instance, lutetium Lu 177 dotatate is approved for treating somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. This radioligand therapy targets specific receptors on tumor cells, similar to how 18F-4FN targets inflammatory cells. Additionally, everolimus, an mTOR inhibitor, is approved for treating advanced neuroendocrine tumors of gastrointestinal or lung origin. While these treatments do not directly align with the mechanism of 18F-4FN, they represent the targeted and imaging-based approaches in managing endocrine neoplasia.

What other types of research exist?

Promising novel alternatives to 18F-4FN for endocrine neoplasia patients include 4-Fluoro-11beta-methoxy-16alpha-18F-fluoroestradiol (4FMFES) for PET imaging of estrogen receptors, and radiolabeled octreotide analogs like (90)Y-DOTA-Tyr(3)-octreotide (TOC) for treatment of metastatic medullary thyroid cancer. These agents have shown efficacy in imaging and treatment, respectively, and could be considered for use in 2024.

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18F-4FN PET Imaging Agent for Inflammation Detection

Phase 1

Recruiting

Led By Lesley Flynt, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Normal range standard renal and liver function tests for age: eGFR >= 60 mL/min/1.73 m2, Bilirubin ≤ the upper limit of normal (ULN), Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ the ULN

Patient >/= 18 years of age

Must not have

Children below the age of 18 are excluded because of the unknown but potential risk of administration of radiopharmaceuticals to minors

Subjects with contraindications to the use of [18F]4FN including confirmed allergy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new imaging dye called 18F-4FN for special scans. It aims to help doctors see inflammation in patients, especially those with immune-related issues. The dye works by sticking to chemicals produced during inflammation, making these areas visible on scans.

Who is the study for?

Adults diagnosed with endocrine tumors or inflammation due to immune checkpoint inhibitors can join. They must have normal kidney and liver function, not be allergic to the test substance, and weigh less than 400 pounds. Pregnant women, lactating mothers, and children under 18 are excluded.

What is being tested?

The trial is testing a new PET imaging agent called 18F-4FN that may help visualize inflammation in patients with endocrine neoplasia by highlighting areas where certain immune cells gather.

What are the potential side effects?

Potential side effects of the imaging agent include reactions related to allergies or sensitivities to its components. Since it's a first-in-human study, other specific side effects are still being evaluated.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney and liver function tests are within normal ranges.

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I am 18 years old or older.

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I have a tumor and have had side effects from immune therapy or suspected inflammation.

Exclusion Criteria

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

Select...

I am 18 years old or older.

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I am not allergic to [18F]4FN.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: 4-[18F]Fluoro-1-NaphtholExperimental Treatment1 Intervention

Participants will receive 1 injection of \[18F\]4FN

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 Endocrine Neoplasia often involve targeted therapies that inhibit specific molecular pathways critical for tumor growth and survival. For example, tyrosine kinase inhibitors (TKIs) like cabozantinib and vandetanib target multiple pathways, including those involved in cell proliferation and angiogenesis. Similarly, mTOR inhibitors like everolimus disrupt cellular metabolism and growth signals. These treatments are crucial for patients as they offer a more precise approach, potentially reducing side effects compared to traditional chemotherapy. The 18F-4FN trial, which uses a PET imaging agent oxidized by reactive oxygen/nitrogen species to detect inflammation, highlights the importance of targeting specific biological processes. This approach can improve diagnostic accuracy and treatment monitoring, ultimately leading to better patient outcomes.

Endocrine and targeted manipulation of breast cancer: summary statement for the Sixth Cambridge Conference.