ReclutandoNCT07761910Registro de ClinicalTrials.gov

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

Non Small Cell Lung Cancer · Cardiotoxicity · Locally Advanced Non-Small Cell Lung Cancer · Radiation Therapy

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De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio: De intervención
Fase: Fase 2
Rango de edad: 18 años - No especificado
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 10 Estimado

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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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).

Leer la descripción completa

As the survival for NSCLC has gradually improved, there is increasing concern about long term radiation-induced cardiac toxicities and support in minimizing the dose to the left anterior descending artery. Myocardial perfusion (the delivery of blood to the heart muscle) evaluated by PET CT scans could be a useful tool to assess early cardiac damage by radiation, so this study will prospectively and quantitatively assess myocardial blood flow and myocardial flow reserve with 18F-Flurpiridaz PET CT prior to and after radiation therapy.

¿Quién podría participar?

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Inclusion Criteria:

1. Age ≥ 18 at time of consent
2. Ability to provide written informed consent and HIPAA authorization
3. Stage III NSCLC per AJCC 8th edition guideline, confirmed by pathological diagnosis and PET/CT.
4. To receive standard definitive concurrent chemoradiation therapy per NCCN guidelines.
5. Tumor estimated to be within 2cm of heart contour or anticipated MHD\>10Gy per treating physician.

Exclusion Criteria:

1. Patients treated with stereotactic body radiotherapy (SBRT).
2. Prior thoracic radiotherapy.

Exclusion for Coronary computed tomography angiography (CCTA)

1. History of a severe anaphylactic reaction to iodinated contrast.
2. Renal insufficiency (defined as estimated CrCl less than 30 mL/min).
3. Inability to hold breath for more than 5 seconds.
4. Patients on radioactive iodine therapy.

Exclusion for 18F-Flurpiridaz PET/CT Test

1. Second-degree AV block, third-degree AV block, and sinus node disease (such as sick sinus syndrome or symptomatic bradycardia) without a functioning pacemaker.

Note: Resting 12-lead EKG will be ordered at the time of enrollment to be performed prior to PET/CT stress test.
2. Patients with bronchospastic diseases including asthma and chronic obstructive pulmonary disease (COPD) who have an acute exacerbation or active wheezing (a high-pitched, musical, adventitious lung sound produced by airflow through the narrowed airways) on the day of PET CT exam.
3. Patients who are hypotensive (systolic blood pressure less than 90 mm Hg) on the day of the PET/CT scan.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: No aplica
Enmascaramiento: Sin enmascaramiento

PET/CT 18F-Flurpiridaz Rest/Stress Test

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

Diagnostic Test: PET/CT 18F-Flurpiridaz Rest/Stress Test · Device: Coronary CT Angiography (CCTA) · Drug: 18F-Flurpiridaz

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

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.