Early Imaging Biomarkers in NSCLC
Açar sözlər
Mücərrəd
Təsvir
This study seeks to investigate the utility of novel imaging biomarkers, namely whole lung volumetric CT scans and cardiac MRI, to non-invasively identify early pathologic changes in pulmonary and cardiac function resulting from thoracic radiation. The ability to identify these changes during the course of treatment offers a powerful tool to optimize radiation dose distributions within uninvolved normal tissue by adapting treatment to the individual patient response. In addition it may lead to other therapeutic interventions designed to reduce long term cardiopulmonary toxicity.
The cardiac MRI will be performed using Aminophylline, Gadopentetate Dimeglumine and Regadenoson. These are not FDA approved for this purpose, but are being used off label and are IND exempt. Additionally, patients will be consented with an optional choice to retain research blood samples for 15 years after the completion of the study. This will allow cutting edge analysis for biomarkers that may be discovered in the future.
Tarixlər
| Son Doğrulandı: | 07/31/2019 |
| İlk təqdim: | 04/13/2017 |
| Təxmini qeydiyyat təqdim edildi: | 04/13/2017 |
| İlk Göndərmə: | 04/19/2017 |
| Son Yeniləmə Göndərildi: | 08/20/2019 |
| Son Yeniləmə Göndərildi: | 08/25/2019 |
| Həqiqi Təhsilin Başlama Tarixi: | 09/22/2015 |
| Təxmini İlkin Tamamlanma Tarixi: | 12/31/2018 |
| Təxmini İşin Tamamlanma Tarixi: | 12/31/2018 |
Vəziyyət və ya xəstəlik
Müdaxilə / müalicə
Other: Lung or Esophageal Patients
Other: Lung or Esophageal Patients
Other: Lung or Esophageal Patients
Other: Lung or Esophageal Patients
Faza
Qol Qrupları
| Qol | Müdaxilə / müalicə |
|---|---|
| Lung or Esophageal Patients Patients with lung or esophageal cancer undergoing conventionally-fractionated radiation therapy. Interventions to be administered include: Imaging Biomarkers using Volumetric CT Scans, Pulmonary using Pulmonary Function Test & 6Minute Hall Walk, Imaging using Cardiac MRI, Specimen Collection using Blood Draws. | Other: Lung or Esophageal Patients Whole lung volumetric CT scans |
Uyğunluq Kriteriyaları
| Təhsil üçün uyğun yaşlar | 18 Years Üçün 18 Years |
| Təhsilə Uyğun Cinslər | All |
| Nümunə götürmə metodu | Non-Probability Sample |
| Sağlam Könüllüləri qəbul edir | Bəli |
| Kriteriyalar | Inclusion Criteria: - Patients receiving once daily fractionated intrathoracic radiation therapy for: - Stage IIA-IIIB non-small cell lung cancer - Limited stage small cell lung cancer - Stage I-III esophageal cancer (neoadjuvant or definitive) - Patients must be 18 years of age or older - Must not be claustrophobic - Must have adequate kidney function Exclusion Criteria: - Patients with small cell lung cancer receiving twice daily (b.i.d.) radiation - Patients with esophageal cancer receiving trastuzamab - Pregnancy or lactation - Claustrophobia - Inability to lie flat for 60-90 minutes - Renal dysfunction with eGFR <60 mL/min/1.73 m2 - Allergy to gadolinium containing contrast media - Implanted devices, metallic hazards or other conditions presenting a contraindication to 3Tesla cardiac MRI |
Nəticə
İlkin nəticə tədbirləri
1. Change from Baseline in Lung Function [1 Year post treatment]
İkincili Nəticə Tədbirləri
1. Change from Baseline in Myocardial Tissue [1 Year post treatment]
2. Change from Baseline in Myocardial Tissue [1 Year post treatment]
3. Change from Baseline in Myocardial Tissue [1 Year post treatment]
4. Radiation Predictors from Baseline in Cardiopulmonary Changes [1 Year post treatment]
Digər nəticə tədbirləri
1. Radiation Induced Change from Baseline in Imaging [6 month and 1 year post treatment]
