Photoacoustic Endoscopy in Endometrial Cancer
2013年7月9日 更新者：Washington University School of Medicine
A Pilot Study of Photoacoustic Endoscopy in Endometrial Cancer
The purpose of this research study is to evaluate whether a new technology called intrauterine photoacoustic endoscopy (PAE) can be used to evaluate the inner lining of the uterus.
調査の概要
状態
引きこもった
詳細な説明
The investigators will evaluate whether this technology can be used and also try to obtain photoacoustic images and functional data (oxygen contents, blood vessel characteristics, etc) of the uterine lining to assess its appearance in women with and without cancer of the endometrium.
Currently, it is difficult for physicians to know whether or not tumors of the endometrium have invaded and spread to other organs without performing an extended surgery called a staging operation (removal of the lymph nodes or glands that drain the uterus to assess under the microscope whether or not the cancer has spread).
Our long term goal is to use this new photoacoustic (PA) technology to improve detection of occult metastatic disease.
Occult disease is defined as tumor which cannot be seen without the use of imaging techniques.
and possibly avoid the need of extended operations.
All of this could result in better care for patients with endometrial cancer and other gynecologic problems.
研究の種類
介入
段階
- 初期フェーズ 1
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
女性
説明
Inclusion Criteria:
- Women diagnosed with benign gynecologic pathology (N=10) or biopsy proven endometrial cancer (N=10) who will undergo hysterectomy.
- Participants must be ≥ 18 years of age.
- Subjects of reproductive potential must have a negative pregnancy test prior to study photoacoustic endoscopy procedure and hysterectomy.
- Subjects must be able understand and willing to sign a written informed consent form.
Exclusion Criteria:
- Subjects with contraindications for general anesthesia or hysterectomy.
- Subjects with evidence of active pelvic inflammatory disease or purulent cervicitis.
- Subjects with prior endometrial ablation procedures.
- Gross tumoral involvement of the cervix or lower genital tract precluding cervical dilatation and endometrial sounding.
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：Photoacoustic endoscopy
This is a one-arm, feasibility study to determine how well the experimental procedure photoacoustic endoscopy will evaluate the human endometrial cavity in vivo.
|
The PAE assessment will be performed in the operating room following strict sterile technique.
PAE is performed immediately prior to the planned surgery.
Participants are prepped following standard protocol.
Length of the endometrial cavity is determined by a uterine sound.
Endocervix is dilated as needed to allow passage of the PAE probe.
The PAE probe will be advanced to the uterine fundus.
Images will be obtained during withdrawal of the PAE probe from fundus to the os.
Recorded images will allow computer assisted image analysis and functional measurements to be performed.
Duration and difficulty of the procedure will be recorded.
Comments and complications will be specifically noted.
他の名前：
Photoacoustic endoscopy probe will be inserted into the endometrial canal to the uterine fundus and images will be obtained during the withdrawal of the probe from the fundus to the endocervical os.
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 |
|---|---|---|
|
Feasibility of using the device to image endometrial cancer
時間枠：12 months or less
|
Feasibility of using this novel device to image endometrial cancer is our primary objective.
The frequency of success in obtaining images, overall and per group, will be presented and binomial success rates with 95% confidence interval estimates will be calculated.
Besides the overall success rates, graphical and tabular summaries of the feasibility across patient demographic and clinical characteristics will be created.
|
12 months or less
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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：Israel Zighelboim, MD、Washington University School of Medicine
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。
一般刊行物
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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
2012年1月1日
一次修了 (予想される)
2012年12月1日
研究の完了 (予想される)
2012年12月1日
試験登録日
最初に提出
2011年12月12日
QC基準を満たした最初の提出物
2011年12月22日
最初の投稿 (見積もり)
2011年12月23日
学習記録の更新
投稿された最後の更新 (見積もり)
2013年7月11日
QC基準を満たした最後の更新が送信されました
2013年7月9日
最終確認日
2013年7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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