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Use of [18F]FECNT in Positron Emission Tomography

2008年3月3日 更新者:National Institute of Mental Health (NIMH)

PET Whole Body Biodistribution and Test Retest Brain Imaging Studies Using a Dopamine Transporter Ligand [18F]FECNT

This study will examine the use of a new radioactive tracer called [18F]FECNT in positron emission tomography (PET) scanning for measuring dopamine transporter (DAT) in the brain. DAT is found in brain neurons (nerve cells) that release the chemical messenger dopamine. By taking pictures of the DAT, scientists hope to learn more about the function of these neurons.

Normal, healthy volunteers between 18 and 65 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, psychological assessment, and blood and urine tests.

Subjects enrolled in the study participate in one of the following procedures:

Brain Imaging Study: Part 1

Two catheters (small plastic tubes) are placed into veins in the subject's arms for injecting [18F]FECNT and for collecting blood samples during the scan. A third catheter is placed into a wrist artery to obtain arterial blood during the scan. With the catheters in place, the subject lies down on the scanner bed with his or her head placed in a special mask that limits movement during the brain scan. The scan begins with an initial x-ray like picture for about 10 minutes, after which the [18F]FECNT is injected and the actual PET scan starts. The entire procedure takes about 6 hours, including 2 hours of continuous scanning sessions, during which the subject is required to lie still. Subjects can relax out of the scanner between scans. They are monitored throughout the procedure. Vital signs are measured and electrocardiogram is taken once before and twice after injection of the tracer. At the end of the scanning, additional blood and urine samples are collected. Subjects are asked to urinate every 2 hours to lessen the radioactivity in the body.

Whole Body Imaging Study: Part 2

For this procedure, a catheter is placed in a vein for injecting the [18F]FECNT tracer. A total of five scans are taken, each one spanning from head to upper thigh. During the course of the scans, x-ray like pictures are obtained. The first scan takes about 100 minutes. Four additional 1-hour scans are done every 100 minutes. The total time for the scans is about 6 hours, and the total time for the entire procedure is about 9 hours. About 2 tablespoons of blood are drawn by needle stick at one time during the imaging. Subjects can leave the PET scanner between scans. They are asked to urinate every 2 hours for 6 hours from the time of tracer injection and to collect all the urine so that radioactivity can be measured.

Brain Imaging Study: Part 3

Part 3 of the study is the same as Part 1, except that two PET procedures are done on separate days, the second within 4 weeks of the first. In addition, participants may also under magnetic resonance imaging (MRI) scanning, a test that uses magnetic fields and radio waves to obtain pictures of the brain.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

The dopamine system plays important roles in various neurological and psychiatric disorders such as Parkinson's disease, schizophrenia, mood disorders, and attention-deficit hyperactivity disorder. Several positron emission tomography (PET) and single photon emission computed topography (SPECT) tracers have been developed including [11C]CFT and [123I]beta-CIT. These tracers have been successfully applied in patients, particularly to stage those with Parkinson's disease. However, these tracers lack selectivity among monoamine (dopamine, serotonin, and norepinephrine) transporters. Recently a new PET tracer, [18F]FECNT brain uptake and washout has been developed, which has high selectivity and affinity to the dopamine transporter (DAT). Part 1 of this study will measure the kinetics of [18F]FECNT brain uptake and washout. Part 2 will estimate radiation-absorbed doses in healthy human subjects by performing whole body PET imaging studies. Part 3 will assess the reliability of measuring DAT densities in the brain by performing a test retest brain PET studies in healthy human subjects. The results of this overall study are required to apply this tracer in various neurological and psychiatric disorders in the future.

研究の種類

介入

入学

30

段階

  • フェーズ 1

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

    • Maryland
      • Bethesda、Maryland、アメリカ、20892
        • National Institute of Mental Health (NIMH)

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

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

INCLUSION CRITERIA:

Healthy subjects ages 18-65

EXCLUSION CRITERIA-WHOLE BODY IMAGING:

Current diagnosis of psychiatric disease, substance dependence or severe systemic disease.

History of substance abuse within 6 months.

Abnormal laboratory tests.

Prior participation in other research protocols within the past year such that a radiation exposure together with the present study would exceed the annual limits.

Pregnancy and breast feeding.

HIV positive.

EXCLUSION CRITERIA-DYNAMIC BRAIN IMAGING:

Current diagnosis of psychiatric disease, substance dependence or severe systemic disease.

History of substance abuse within 6 months.

Abnormal laboratory tests.

Novocain allergy.

Prior participation in other research protocols within the past year such that a radiation exposure together with the present study would exceed the annual limits.

Any condition that increases increase risk for MRI (e.g., pacemaker, metallic foreign body in the eye).

Pregnancy and breast feeding.

HIV positive.

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:処理

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。

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

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

2004年5月1日

研究の完了

2005年9月1日

試験登録日

最初に提出

2004年5月27日

QC基準を満たした最初の提出物

2004年5月26日

最初の投稿 (見積もり)

2004年5月27日

学習記録の更新

投稿された最後の更新 (見積もり)

2008年3月4日

QC基準を満たした最後の更新が送信されました

2008年3月3日

最終確認日

2005年9月1日

詳しくは

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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