胸部放射線療法後の心筋損傷の初期徴候を評価するためのイメージングおよび血液ベースのバイオマーカー
イメージングと血液ベースのバイオマーカーを使用して、胸部放射線療法後の心筋損傷の初期兆候を評価するパイロット研究
This study assesses for early signs of damage to the heart following chest radiation therapy using both imaging (cardiac magnetic resonance imaging and cardiac positron emission tomography) and changes in blood biomarkers. This study determines if any changes in the heart muscle can be detected either during the course of radiation therapy or shortly thereafter using specialized imaging techniques or blood tests. Cardiac magnetic resonance imaging may be used to help provide information about changes in the heart structure and function following radiation therapy. Positron emission tomography looks at differences in how the heart takes up radioactive sugar which is injected into the vein to assess changes in heart function following radiation therapy. This study may help identify patients at risk of heart issues following radiation therapy to the chest and ultimately help in the development of more effective and safe treatments for cancer in the future.
調査の概要
状態
詳細な説明
PRIMARY OBJECTIVES:
I. To evaluate and quantitate early changes in myocardial fibrosis following thoracic radiation therapy (RT).
II. To assess quantitative early changes in myocardial inflammation after thoracic RT.
III. To determine if thoracic RT is associated with early changes in myocardial metabolism as assessed with cardiac positron emission tomography (PET).
SECONDARY OBJECTIVES:
I. To evaluate and quantitate early changes in subclinical myocardial dysfunction after thoracic RT.
II. To determine if thoracic RT is associated with early changes in myocardial metabolism using alternative cardiac PET-derived biomarkers.
III. To evaluate and quantitate early changes in blood-based biomarkers after thoracic RT.
IV. To assess the incidence and severity of cardiac events following completion of thoracic RT.
OUTLINE:
Within 2 weeks of starting RT, patients undergo cardiac magnetic resonance (CMR) imaging, cardiac positron emission tomography (PET)/computed tomography (CT) and blood sample collection at baseline, then between fractions 12-17 of RT and at 6 months after completion of RT.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Ohio
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Columbus、Ohio、アメリカ、43210
- Ohio State University Comprehensive Cancer Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Patients suitable to undergo thoracic RT for histologically confirmed non-small cell lung cancer (NSCLC) OR histologically confirmed clinical stage I-IVA (American Joint Committee on Cancer [AJCC] 8th edition [ed]) middle or thoracic esophageal or gastroesophageal cancer (squamous cell carcinoma or adenocarcinoma) at Ohio State University Comprehensive Cancer Center
説明
Inclusion Criteria:
- Patients who have been evaluated by a radiation oncologist and have been felt to be suitable to undergo thoracic RT for histologically confirmed NSCLC with a dose range of 60-70 Gy at 1.8-2 Gy per fraction OR histologically confirmed clinical stage I-IVA (AJCC 8th ed) middle or thoracic esophageal or gastroesophageal cancer (squamous cell carcinoma or adenocarcinoma) with a planned dose range of 41.4-60 Gy at 1.8-2 Gy per fraction as part of treatment of their malignancy
- Concurrent chemotherapy is permitted
- For NSCLC patients, both concurrent and/or adjuvant immunotherapy is permitted
- Patients participating in other research studies are eligible as long as participation in this study does not interfere with activities required in the other studies
- Patients with no contra-indications to magnetic resonance (MR) or PET imaging as stated in the section exclusion criteria
- For the delayed enhancement and the T1 contrast mapping portions of the study, the patient must have an adequate baseline renal function defined as an estimated glomerular filtration rate (eGFR) > 30 ml/min per the Ohio State Institutional Guidelines. Of note, if the patient's eGFR is =< 30 ml/min, the patient would still be eligible for enrollment, but only the strain-encoded (SENC) imaging and T2 mapping non-contrast sequences would be obtained. The dynamic contrast-enhanced (DCE) and T1 mapping sequences, which require intravenous (IV) contrast, would not be included
- Patients with moderate to end-stage renal disease, or who are at high-risk of nephrogenic systemic fibrosis (e.g. hepatorenal syndrome, liver transplant, acute renal failure, chronic kidney disease, and iron overload conditions) would still be eligible for enrollment, but only the non-contrast SENC and T2 mapping imaging sequences would be obtained. The DCE and T1 mapping sequences, which require IV contrast, would not be included
- Age >= 18 years old
- Within 4 weeks of study entry: patients must have vital signs, history/physical examination, and kidney function test (eGFR)
- Ability to provide written informed consent obtained prior to participation in the study and any study specific procedures being performed
- Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of the study entry. Urine human chorionic gonadotropin (HCG) is an acceptable pregnancy assessment
Exclusion Criteria:
- Subjects who are breast-feeding, or have a positive pregnancy test will be excluded from the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Medical contraindications to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, known contrast allergy to Gadolinium contrast, pregnancy, nursing mothers, weight greater than 350 pounds)
- Subjects with advanced renal disease (eGFR < 45 mL/min/1.72m^2) - exclusion from receipt of contrast, but may still be enrolled for basic CMR imaging (left ventricular ejection [LVEF], strain, T2, etc)
- Medical contraindications to PET imaging (e.g. pregnancy, nursing mothers, weight greater than 420 pounds - scanner limit)
- Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other condition that could prevent compliance with study procedures or providing informed consent
- Subjects who are prisoners
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:COHORT
- 時間の展望:PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Ancillary-correlative (CMR, PET/CT, biospecimen collection)
Within 2 weeks of starting RT, patients undergo CMR, cardiac PET/CT and blood sample collection at baseline, then between fractions 12-17 of RT and at 6 months after completion of RT. |
Undergo blood sample collection
他の名前:
Undergo cardiac PET/CT
他の名前:
Undergo CMR
他の名前:
Undergo cardiac PET/CT
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in extracellular volume (ECV)
時間枠:Baseline up to 6 months post-radiation therapy (RT)
|
To identify the presence of cardiac fibrosis as assessed by cardiac magnetic resonance-derived ECV during and shortly after RT. |
Baseline up to 6 months post-radiation therapy (RT)
|
|
Changes in myocardial T2
時間枠:Baseline up to 6 months post-RT
|
To identify the presence of cardiac magnetic resonance-derived cardiac inflammation using T2 mapping during and shortly after RT. |
Baseline up to 6 months post-RT
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Changes in myocardial metabolism
時間枠:Baseline up to 6 months post-RT
|
To identify changes in myocardial metabolism measured as standardized uptake value (SUV) max during and shortly after RT using myocardial PET. |
Baseline up to 6 months post-RT
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Blood-based biomarkers
時間枠:Baseline up 6 to months post-RT
|
Biomarkers including serum troponin, N-terminal Pro Brain-type Natriuretic Peptide (NT-proBNP), C-reactive protein, carboxy-terminal propeptide of procollagen type I (PICP), and amino-terminal propeptide of procollagen type I (PINP) will be measured. |
Baseline up 6 to months post-RT
|
協力者と研究者
捜査官
- 主任研究者:Eric D Miller, MD, PhD、Ohio State University Comprehensive Cancer Center
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- OSU-20351
- NCI-2021-08714 (レジストリ識別子:CTRP (Clinical Trial Reporting Program))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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