Prospective Study on Radiation Induced Cardiotoxicity Assessed By PET-CT for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University

About this trial

Prospective clinical study designed to evaluate damage to the heart after receiving standard of care chemotherapy and radiation therapy for locally advanced Non-Small Cell Lung Cancer (NSCLC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 at time of consent

Ability to provide written informed consent and HIPAA authorization

Stage III NSCLC per AJCC 8th edition guideline, confirmed by pathological diagnosis and PET/CT.

To receive standard definitive concurrent chemoradiation therapy per NCCN guidelines.

Disqualifiers

Patients treated with stereotactic body radiotherapy (SBRT).

Prior thoracic radiotherapy.

History of a severe anaphylactic reaction to iodinated contrast.

Renal insufficiency (defined as estimated CrCl less than 30 mL/min).

Trial design

Design model

Single group

Treatments tested in this trial

  • PET/CT 18F-Flurpiridaz Rest/Stress Test

    Diagnostic test

    A two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT before and 3 months after SOC radiation treatment.

  • Coronary CT Angiography (CCTA)

    Device

    Coronary computed tomographic angiography (CCTA) scan is a highly accurate noninvasive technique for detection of coronary artery plaque.

  • 18F-Flurpiridaz

    Drug

    A two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT before and 3 months after SOC radiation treatment

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: PET/CT 18F-Flurpiridaz Rest/Stress TestExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Change of MBF (myocardial blood flow)

Assessed using a two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT

Time frame
Pre-radiotherapy and 3 months post-radiotherapy

Secondary outcomes

1

Changes in myocardial blood flow to the cardiac base

Assessed using a two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT

Time frame
Pre-radiotherapy and 3 months post-radiotherapy
2

Changes in myocardial blood flow to the left ventricle

Assessed using a two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT

Time frame
Pre-radiotherapy and 3 months post-radiotherapy
3

Changes in myocardial blood flow to right coronary artery

Assessed using a two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT

Time frame
Pre-radiotherapy and 3 months post-radiotherapy
4

Changes in myocardial blood flow to left circumflex artery

Assessed using a two-phase, rest and regadenoson stress evaluated by 18F-Flurpiridaz PET/CT

Time frame
Pre-radiotherapy and 3 months post-radiotherapy

Other outcomes

Sponsors and contacts

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