What side effects are associated with this type of intervention?

Common treatments for lung cancer, including radiotracers like [18F]-C-SNAT4 used in PET imaging, targeted therapies, immunotherapies, and chemotherapy, have various side effects. Radiotracers generally have minimal acute toxicity but require monitoring for safety profiles. Targeted therapies, such as dabrafenib and sotorasib, can cause serious adverse events like cutaneous squamous-cell carcinoma, hepatotoxicity, and intracranial hemorrhage. Immunotherapies like durvalumab may lead to pneumonia, pneumonitis, and rash. Chemotherapy often results in cumulative toxicities, including nausea, vomiting, and fatigue. It is crucial to balance efficacy with the potential for adverse effects when selecting a treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for lung cancer, including targeted therapies and chemotherapies. For instance, gefitinib and osimertinib are approved for EGFR mutation-positive non-small cell lung cancer (NSCLC). While specific FDA approvals for radiotracers like [18F]-C-SNAT4 are not detailed in the provided documents, PET imaging agents are crucial in diagnosing and managing lung cancer by helping to visualize tumor activity and assess treatment response. Broadly, the use of radiotracers in PET imaging is an established practice in oncology, aiding in the precise localization and characterization of tumors.

What other types of research exist?

Promising novel alternatives to [18F]-C-SNAT4 for PET imaging in lung cancer patients include NMK36 (trans-1-amino-3-[18F]fluorocyclobutanecarboxylic acid), which has shown safety and diagnostic performance in primary prostate cancer, and [18F]TRACK, a PET tracer for Tropomyosin Receptor Kinases, which has been evaluated for brain imaging but may have potential applications in other cancers. Additionally, [68Ga]-labeled cyclic RGD dimer has been identified as a potential PET radiotracer for tumor imaging.

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Radiopharmaceutical

18F-C-SNAT4 for Lung Cancer

Phase 1 & 2

Waitlist Available

Led By Sanjiv Gambhir, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Karnofsky Performance Status (KPS) ≥ 60

Be older than 18 years old

Must not have

History of allergic reactions to IV contrasts or reactions attributed to compounds of similar chemical or biological composition to [18F]-C-SNAT4 used in study.

Patients who exceed the safe weight limit of the PET/CT bed (204.5 kg) or who cannot fit through the PET/CT bore (diameter 70 cm).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new imaging agent called [18F]-C-SNAT4 in both healthy people and lung cancer patients. The goal is to see how the agent spreads in the body, measure its safety, and determine how well it highlights cancerous tissues compared to normal ones.

Who is the study for?

This trial is for healthy volunteers and lung cancer patients with normal blood counts, liver function, and no severe illnesses in the past month. Women must not be pregnant and all participants should understand the study well enough to consent.

What is being tested?

The trial tests a new PET/CT scan radiotracer called 18F-C-SNAT4. It aims to see how this tracer spreads in the body, its safety, toxicity levels, and if it can clearly show lung cancer compared to non-cancerous tissue.

What are the potential side effects?

Potential side effects may include allergic reactions similar to those from IV contrasts or other compounds related to the radiotracer. The full range of side effects will be determined during the trial.

Eligibility Criteria

Inclusion Criteria

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

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I can care for myself but may need occasional help.

Exclusion Criteria

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

Select...

I am allergic to certain IV contrasts or similar compounds.

Select...

I weigh less than 204.5 kg and can fit into a 70 cm wide scanner.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Biodistribution of [18F]-C-SNAT4

Secondary study objectives

18F]-C-SNAT4 Uptake

Dosimetry of [18F]-C-SNAT4

The Maximal [18F]-C-SNAT4 Uptake as PET Radiotracer

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Patients with newly diagnosed lung cancer (Group 2)Experimental Treatment2 Interventions

Group2 (n = 5) newly diagnosed lung cancer. Each participant in this part of the study will receive a single dose of \[18F\]-C-SNAT4 and then undergo three times of whole body (WB) PET/CT scans (Scan 1: 60 minutes dynamic scan; Scan 2: WB skull base-thigh at 90 minutes +/- 10 minutes post injection; Scan 3: WB skull base-thigh at 120 minutes +/- 10 minutes post-injection of \[18F\]-C-SNAT4).

Group II: Patients with lung cancer undergoing non-surgical tx (Group 3)Experimental Treatment2 Interventions

Group 3 (n = 10) lung cancer after non-surgical therapy. Each participant in this part of the study will receive a total of 2 doses of \[18F\]-C-SNAT4 (on 2 separate occasions spaced at least 1 week apart, each of which will be followed by undergoing a \[18F\]-C-SNAT4 PET/CT scan)

Group III: Healthy volunteers (Group 1)Active Control2 Interventions

Group 1(n = 5) healthy volunteers. Each participant in this part of the study will receive a single dose of \[18F\]-C-SNAT4 and then undergo three times of whole body (WB) PET/CT scans (Scan 1: 60 minutes dynamic scan; Scan 2: WB skull base-thigh at 90 minutes +/- 10 minutes post injection; Scan 3: WB skull base-thigh at 120 minutes +/- 10 minutes post-injection of \[18F\]-C-SNAT4).

0 / 3Eligibility 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

Lung cancer treatments often involve a combination of surgery, chemotherapy, radiation therapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cancer cells, while radiation therapy uses high-energy rays to destroy cancer cells. Targeted therapies, such as EGFR inhibitors (e.g., osimertinib) and ALK inhibitors (e.g., crizotinib), block specific molecules involved in cancer growth. Immunotherapies, like PD-1/PD-L1 inhibitors, enhance the immune system's ability to fight cancer. PET imaging with radiotracers like [18F]-C-SNAT4 is crucial for diagnosing, staging, and monitoring treatment response by highlighting metabolic activity in cancer cells. This comprehensive approach allows for personalized treatment plans, improving outcomes and quality of life for lung cancer patients.

A Review of Recent Advances in the Treatment of Elderly and Poor Performance NSCLC.Non-Small Cell Lung Cancer beyond Biomarkers: The Evolving Landscape of Clinical Trial Design.Customizing chemotherapy in non-small cell lung cancer: the promise is still unmet.