What is the mechanism of action of this treatment?

Radiation therapy for lung cancer works by producing reactive oxygen species (ROS) that cause oxidative damage to cellular components, including mitochondrial proteins, leading to mitochondrial dysfunction and cell death. This is crucial for lung cancer patients as it directly targets and destroys cancer cells. Chemotherapy involves cytotoxic drugs that interfere with cell division, leading to cancer cell death, while targeted therapies inhibit specific molecular pathways essential for cancer cell survival and proliferation. Understanding these mechanisms helps in tailoring treatments to maximize efficacy and minimize side effects for lung cancer patients.

What side effects are associated with this type of intervention?

Common treatments for lung cancer, particularly radiation therapy, can lead to several side effects. These include cardiotoxicity, such as myocardial infarction, heart failure, and valvular disorders, due to oxidative damage from reactive oxygen species (ROS) produced by ionizing radiation. Pulmonary complications like pneumonitis and long-term lung function impairment are also common. Other side effects may include fatigue, skin reactions, esophagitis, and an increased risk of secondary cancers.

What prior FDA approvals exist?

Several FDA-approved treatments for lung cancer include chemotherapy, immunotherapy, and targeted therapies. Chemotherapy agents such as carboplatin and paclitaxel are commonly used, often in combination with radiation therapy. Immunotherapy drugs like pembrolizumab and atezolizumab have been approved for their efficacy in improving overall survival in patients with advanced non-small cell lung cancer (NSCLC). Targeted therapies, including drugs like cemiplimab, have shown benefits in patients with specific genetic markers such as PD-L1 expression. These treatments, particularly when combined with radiation therapy, aim to enhance the therapeutic effects by inducing oxidative stress and mitochondrial dysfunction in cancer cells.

What other types of research exist?

Promising novel alternatives to radiation therapy for lung cancer patients include immune checkpoint inhibitors (such as pembrolizumab and nivolumab) and targeted therapies (such as larotrectinib and entrectinib for tumors with specific gene fusions). These therapies have demonstrated efficacy in clinical trials and offer a different mechanism of action that does not involve ionizing radiation.

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Metabolic Imaging Agent

Metabolic Imaging for Detecting Heart Damage After Radiation in Breast Cancer Patients

Phase < 1

Recruiting

Led By Prasanna Alluri, MD, PhD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

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

Must have

ECOG performance status 0-1

Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy

Must not have

Diagnosis of connective tissue disorders, including systemic lupus erythematosis, scleroderma, or dermatomyositis

Prior radiation involving the heart

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 month before the radiation

Awards & highlights

No Placebo-Only Group

Summary

This trial uses advanced imaging techniques to detect early heart damage in women with left-sided breast cancer receiving radiation therapy. By observing how the heart processes a special substance, doctors can identify early signs of damage before it becomes severe.

Who is the study for?

This trial is for individuals with left-sided breast or thoracic tumors, stages I-IV, who are expected to live at least 6 months and can undergo standard radiation therapy. They must be able to perform daily activities (ECOG status 0-1), use contraception if of childbearing potential, and provide informed consent. Excluded are those with life expectancy under 6 months, prior heart radiation, taking cardiotoxic drugs within the last 6 months, severe illnesses or conditions that affect MRI safety.

What is being tested?

[1-13C]pyruvate used in conjunction with MRI imaging aims to detect early mitochondrial changes in the heart as a marker for subclinical damage from radiation therapy in patients receiving standard care for breast or thoracic cancer. The study focuses on identifying cardiac injury before symptoms appear by monitoring metabolic shifts caused by treatment.

What are the potential side effects?

While this trial primarily uses diagnostic tools rather than therapeutic interventions, risks may include typical MRI-related discomforts such as claustrophobia and loud noises during scanning. The contrast agent [1-13C]pyruvate's side effects aren't detailed but could potentially include reactions at the injection site or allergic responses.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

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I agree to use effective birth control or abstain from sex during and for 90 days after the study.

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My breast or thorax tumor is on the left side, and if it's stage IV, I am expected to live 6 months or more.

Exclusion Criteria

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

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I have been diagnosed with a connective tissue disorder like lupus, scleroderma, or dermatomyositis.

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I have had radiation treatment that involved my heart.

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My doctor expects I have less than 6 months to live due to stage IV cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 month before the radiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 month before the radiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 month before the radiation for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To determine if radiation-induced cardiac injury causes myocardial mitochondrial dysfunction

Secondary study objectives

Determination of the prognostic value decreased of myocardial mitochondrial pyruvate flux in predicting clinically significant radiation induced cardiotoxicity.

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: Single Arm:Diagnosing Cardiotoxicity when on Radiation therapyExperimental Treatment1 Intervention

0 / 6Eligibility 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

Radiation therapy for lung cancer works by producing reactive oxygen species (ROS) that cause oxidative damage to cellular components, including mitochondrial proteins, leading to mitochondrial dysfunction and cell death. This is crucial for lung cancer patients as it directly targets and destroys cancer cells. Chemotherapy involves cytotoxic drugs that interfere with cell division, leading to cancer cell death, while targeted therapies inhibit specific molecular pathways essential for cancer cell survival and proliferation. Understanding these mechanisms helps in tailoring treatments to maximize efficacy and minimize side effects for lung cancer patients.