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Cardiac Fibrosis by CMR in Patients With Cancer

2018年9月12日 更新者:Tomas Neilan, MD、Massachusetts General Hospital

Non-invasive Detection of Cardiac Fibrosis After Administration of Doxorubicin-based Chemotherapy in Patients With Lymphoma Using Cardiac Magnetic Resonance

A study to test the effectiveness of an investigational imaging technique for detecting cardiac injury after the administration of certain chemotherapies, such as doxorubicin. "Investigational" means that the imaging technique is still being studied and that research doctors are trying to find out more about it- such as whether the technique can detect lower levels of cardiac injury after treatment with doxorubicin. It also means that the FDA (the U.S. Food and Drug Administration) has not yet approved the use of gadolinium or approved the use of CMR studies for detection of cardiac toxicity after doxorubicin.

The chemotherapy drug that you have been scheduled to be treated with, doxorubicin, has been associated with the development of heart failure in some patients. Cardiac Magnetic Resonance (CMR) is a type of MRI scan that uses a magnetic field to produce pictures of the heart. The CMR scan has been used in other studies and information from those other research studies suggest that this imaging technique may help to better detect differences in the structure of the heart muscle after treatment with doxorubicin. In this research study, we hope that we can better detect changes in the heart muscle after treatment with doxorubicin with a CMR scan in the hopes that cardiac injury can be detected and treated earlier to ultimately prevent the possible development of heart failure

調査の概要

状態

引きこもった

条件

詳細な説明

If you choose to take part in this study, we will ask you to sign this consent form before we do any study procedures. All participants will come in for a CMR scan prior to their first treatment with doxorubicin

- Visit 1 Visit 1 will take place prior to starting chemotherapy. The visit will take about 1.5 hours. We will ask you to come to the Shapiro Cardiovascular Center at the Brigham and Women's Hospital or Massachusetts General Hospital for your study visit.

For subjects that qualify, we will bring you for the heart CMR scan, an echocardiogram and some blood work.

Blood testing: Before your CMR scan we will take some blood via the IV cannula. We will take about 4 tubes of blood. This is equivalent to 2 ½ tablespoons of blood. From this blood we will test for blood markers of cardiac injury and compare these results to your other tests.

CMR Scan: For the CMR scan, you will be asked to lie still on the scanner table that slides into a tunnel-shaped machine. Four electrocardiogram (EKG) patches with wires attached will be placed on your chest or your back to check your heart rate. We will place an intravenous (IV) catheter in one of your arms. An IV catheter is a thin plastic tube that is put into a vein with a needle. The IV catheter will be used to give you a CMR contrast dye (gadolinium). The dye will help us to identify subtle changes within the heart muscle. This dye, gadolinium, is used routinely in CMR studies. We will also draw a sample of blood from the IV catheter to measure your red blood cell count. Then, the scanner table will move slowly into the tunnel-shaped CMR machine so the pictures can be taken. The machine is slightly wider than your body and there may be little room to move. If you feel any discomfort or need to stop the test, you will be able to tell this to the research staff. You will be able to speak to them while you are having the CMR and they will be able to speak to you. If you think that you might be too anxious about being inside the narrow CMR scanner for a long period of time, we may prescribe a drug called to help relax you if you think it might be helpful.

The CMR scan will take one hour.

Echocardiogram: An echocardiogram is a test used by doctors to monitor heart function. An echocardiogram is a safe test that uses ultrasound to image the heart. After completion of the CMR test, you will have an echocardiogram. This test will take place in the same area as the CMR test. The echocardiogram test will take 40 minutes.

- Visit 2: Visit 2 will take place about 2-4 weeks after your last cycle of doxorubicin chemotherapy.

When you come back for Visit 2, you will have the same type of CMR scan, echocardiogram and blood testing that you had during Visit 1.

- Visit 3: At visit three we will perform an exercise test on a bicycle. The test is designed to test the oxygen consumption of your body when exercising. It provides a way of quantifying the ability of the body to exercise. This test will take 30 minutes. During this test subjects sit on the bicycle for at least 3 minutes pedaling at a rate of 60 cycles per minute and slowly the work-load is increased until peak exercise is obtained. We define peak exercise as being tired or breathless. Heart rate and blood pressure are recorded during the test. During the test you will breathe through a mouthpiece from which we will measure oxygen levels.

研究の種類

観察的

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Massachusetts
      • Boston、Massachusetts、アメリカ、02114
        • Massachusetts General Hospital
      • Boston、Massachusetts、アメリカ、02215
        • Brigham and Women's Hospital
      • Boston、Massachusetts、アメリカ、02215
        • Dana Farber Cancer Insitute

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

確率サンプル

調査対象母集団

Patients receiving chemotherapy

説明

Inclusion Criteria:

  • Aged ≥ 18 and able to give consent
  • New diagnosis of lymphoma and scheduled to undergo doxorubicin (DOX)-based chemotherapy.

Exclusion Criteria:

  • Concurrent radiotherapy prior to the performance of both CMR studies, however consolidative radiotherapy after the completion of DOX and after the acquisition of the second CMR study is acceptable
  • No prior malignancy treated with chemotherapy or mediastinal radiotherapy
  • No contraindications to the performance of a magnetic resonance study:
  • The presence of an implanted metallic object such as a cardiac pacemaker or implantable defibrillator
  • An implanted neural stimulator
  • Any ferromagnetic implants not deemed MRI-safe
  • Intra-ocular metallic foreign bodies
  • Severe claustrophobia
  • Pregnancy
  • Inability to perform an exercise test
  • Glomerular filtration rate < 60 ml/min/1.73 m2

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Cardiac Magnetic Resonance
Cardiac Magnetic Resonance scan at visits 1 and 2
Cardiac Magnetic Resonance Scan

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
Myocardial ECV
時間枠:2 Years
- To determine if a novel cardiac magnetic resonance-based index, the extracellular volume fraction (ECV), of myocardial fibrosis is altered early after doxorubicin-based chemotherapy.
2 Years

二次結果の測定

結果測定
メジャーの説明
時間枠
Alteration of serum biomarkers after doxorubicin based chemotherapy
時間枠:2 years
- To determine if serum biomarkers of cardiac stress, collagen turn-over, and myocardial injury are altered after doxorubicin-based chemotherapy
2 years
Alteration of echocardiographic indices after doxorubicin-based chemotherapy
時間枠:2 Years
- To determine if conventional and novel echocardiographic indices are altered after doxorubicin-based chemotherapy.
2 Years
Measurement of cardiopulmonary functional capacity
時間枠:2 years
- To determine if measures of cardiopulmonary functional capacity are abnormal after doxorubicin-based chemotherapy.
2 years
Determine association between measurements pre- and post-doxorubicin-based chemotherapy
時間枠:2 Years
- To determine if there is an association between CMR, echocardiographic, serum, and functional measures pre- and post doxorubicin-based chemotherapy
2 Years

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Tomas Neilan, MD、Massachusetts General Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2013年3月1日

一次修了 (実際)

2018年8月25日

研究の完了 (実際)

2018年8月25日

試験登録日

最初に提出

2013年7月11日

QC基準を満たした最初の提出物

2013年7月20日

最初の投稿 (見積もり)

2013年7月24日

学習記録の更新

投稿された最後の更新 (実際)

2018年9月14日

QC基準を満たした最後の更新が送信されました

2018年9月12日

最終確認日

2018年9月1日

詳しくは

本研究に関する用語

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

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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