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Developing a Novel Imaging Biomarker in the Differential Diagnosis of Parkinson's Disease and Parkinsonism

2018年10月2日 更新者:Yi-Hsin Weng、Chang Gung Memorial Hospital

Developing a Novel Imaging Biomarker in the Differential Diagnosis of Parkinson's Disease and Parkinsonism by 18F-DTBZ PET

This study will compare the brain uptake of 18F- DTBZ in 20 patients with PD, 20 patients with MSA, 20 patients with PSP, 20 patients with CBS, and 20 patients with VaP, 20 patients with ET, and 10 patients with DT.

調査の概要

状態

完了

介入・治療

詳細な説明

Study duration is expected to be completed in a period of 4 year. This study is a uncontrolled, open-label, non-randomized, parallel, and cross-sectional study. Total 130 subjects, including 20 patients with PD, 20 patients with MSA, 20 patients with PSP, 20 patients with CBS, 20 patients with VaP, 20 patients with ET, and 10 patients with DT, will be enrolled.

Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping, each subject will have 3 visits in this study, as one screening visit, one imaging visit, and one safety evaluation visit.

Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.

研究の種類

介入

入学 (実際)

72

段階

  • フェーズ2

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

      • Taoyuan、台湾、333
        • Chang Gung Memory Hospital

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

20年~80年 (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

説明

Inclusion Criteria:

  1. Twenty subjects with a diagnosis of PD whom must:

    i. Male or female patients, age range 20~80. ii. Patients should be fulfilled "UK Parkinson's Disease Society Brain Bank Criteria for the Diagnosis of PD" (Appendix I).

    iii. Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).

  2. Twenty subjects with a diagnosis of MSA whom must:

    i. Male or female patients, age range 20~80. ii. Patients should be fulfilled the Consensus diagnostic criteria of "possible" or "probable" MSA14 (Appendix I).

    iii. Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).

  3. Twenty subjects with a diagnosis of PSP whom must:

    i. Male or female patients, age range 20~80. ii. Patients should be fulfilled the NINDS-SPSP clinical criteria for the diagnosis of PSP " as possible" or "probable" PSP55 (Appendix III).

    iii. Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).

  4. Twenty subjects with a diagnosis of CBS whom must:

    i. Male or female patients, age range 20~80. ii. Patients should be fulfilled the"Mayo Clinic proposed criteria for the diagnosis for corticobasal syndrome"56 (Appendix I).

    iii. Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).

  5. Twenty subjects with a diagnosis of VaP whom must:

    i. Male or female patients, age range 20~80. ii. Patients should be fulfilled the clinical diagnostic criteria of vascular parkinsonism. (Appendix I).

    iii. Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).

  6. Twenty subjects with a diagnosis of ET whom must:

    i. Male or female patients, age range 20~80. ii. Patients should be fulfilled the "The Consensus Criteria of the MDS on Essential Tremor"30. (Appendix I).

    iii. Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).

  7. Ten subjects with a diagnosis of DT whom must:

    i. Male or female patients, age range 20~80. ii. Patients should be fulfilled the "The Consensus Criteria of the MDS on Dystonic Tremor"30. (Appendix I).

iii. Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).

Exclusion Criteria:

  1. Pregnant or becoming pregnant during the study (as documented by pregnancy testing at screening or at any date during the study according to the PI discretion) or current breast feeding..
  2. Any subject who has a clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness.

    i. Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances.

    ii. Current clinically significant cardiovascular disease. (cardiac surgery or myocardial infarction within the last 6 months; unstable angina; decompensated congestive heart failure; significant cardiac arrhythmia; congenital heart disease.

  3. History of drug or alcohol abuse within the last year, or prior prolonged history of abuse.
  4. History or presence of QTc prolongation.
  5. History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation.
  6. Any documented abnormality in the brain by CT or MRI of brain, which might contribute to the motor function, such as hydrocephalus and encephalomalacia, will be excluded. Mild cortical atrophy and non-specific white matter changes will be allowed.
  7. Patients who have the evidence of secondary parkinsonism or other neurodegenerative diseases, such as spinocerellar atrophy (SCA), Wilson's disease, hydrocephalus , serious head injury and definite history of neurotoxin exposure, are excluded.
  8. History of allergy to radioligands that contain 18F isotope.

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

  • 主な目的:診断
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:18F-DTBZ for Parkinson's Disease and parkinsonism

This study will compare the brain uptake of 18F- DTBZ in 20 patients with PD, 20 patients with MSA, 20 patients with PSP, 20 patients with CBS, and 20 patients with VaP, 20 patients with ET, and 10 patients with DT.

Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping, each subject will have 3 visits in this study. Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.

During this study, subjects will receive a single i.v. administration of approximately 10 mCi 18F-DTBZ immediately prior to imaging.

The proposed dose for this study is based on our phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG.

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
Analyzing the differences of monoaminergic degeneration between each group by comparing the SUVR of 18F- DTBZ measured by the VOIs methods in each brain region.
時間枠:4 years

During this study, subjects will receive a single i.v. administration of approximately 10 mCi 18F-DTBZ immediately prior to imaging.

The proposed dose for this study is based on our phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG.

4 years

二次結果の測定

結果測定
メジャーの説明
時間枠
Statistical parametrical mapping will be performed to compare the early-phase and delayed-phase imaging of 18F- DTBZ PET in each group.
時間枠:4 years
Statistical parametrical mapping (SPM) will be performed to compare the early-phase (cerebral perfusion) and delayed-phase (monoaminergic system) imaging of 18F- DTBZ PET in each group. The capability of 18F- DTBZ PET imaging as an imaging biomarker in differentiating PD and PM will be also investigated.
4 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。

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

2013年2月1日

一次修了 (実際)

2018年7月31日

研究の完了 (実際)

2018年7月31日

試験登録日

最初に提出

2014年2月7日

QC基準を満たした最初の提出物

2014年2月7日

最初の投稿 (見積もり)

2014年2月11日

学習記録の更新

投稿された最後の更新 (実際)

2018年10月3日

QC基準を満たした最後の更新が送信されました

2018年10月2日

最終確認日

2018年10月1日

詳しくは

本研究に関する用語

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