High-Resolution Microendoscopy to Guide Hysteroscopic Tumor Resection
Use of Fluorescence Imaging and High-Resolution Microendoscopy to Guide Hysteroscopic Tumor Resection in Patients With Endometrial Cancer
調査の概要
詳細な説明
Tissue Collection and Imaging:
If participant is found to be eligible to take part in this study, during their standard-of-care hysterectomy, a tissue sample will be collected. This sample will be used for research and routine testing. Participant will sign a separate consent form for the hysterectomy.
During the hysterectomy, photographs of the tissue will be taken. Participant's private areas will be covered (as much as possible), and a picture of their face will not be taken.
A hysteroscopy will also be performed during participant's surgery. Participant's doctor will discuss the risks of the hysteroscopy with participant and they will be asked to sign a separate consent form. A hysteroscopy allows the doctor to look inside the uterus to see the tissue that is going to be collected for research imaging. This procedure is done with a tool called a hysteroscope, a long thin tube with a camera and a light. The hysteroscope will be inserted though the vagina and up into the uterus. An image will be displayed on a computer screen that is attached to the hysteroscope. The study doctor will use the image on the screen to look at different areas of the uterus to find the location and size of the tumor(s). This image may be recorded for future reference.
After the hysteroscopy, the study doctor will inject a contrast dye (Proflavine Hemisulfate) into participant's uterus to help the doctor see the lesions. A camera will then be used to photograph images of the uterus.
The tissue collection and the imaging will add about 45 minutes to participant's hysterectomy procedure.
Length of Study:
Patient's active participation in this study will be over after surgery.
Follow-Up Call:
About 30 days (+/-7 days) after the surgery, participant will be called and asked how they are doing.
This is an investigational study. The hysteroscope is commercially available and FDA approved for laparoscopic procedures. The use of the hysteroscope in this study is for research purposes only.
Proflavine Hemisulfate (contrast dye) is commercially available and FDA approved for treating umbilical cord stumps. Its use in this study is considered investigational.
Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.
研究の種類
段階
- フェーズ2
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
説明
Inclusion Criteria:
- Any patient with a confirmed preoperative diagnosis of endometrial cancer
- Histologic subtype limited to endometrioid adenocarcinoma
- Patients with any grade of endometrial cancer (histologically confirmed)
- Patients with no contraindications to surgery
- Patients scheduled for hysterectomy by laparotomy, laparoscopy, or robotic surgery
- Patient must have had a preoperative MRI within 30 days of surgery at MD Anderson Cancer Center. Outside imaging will be allowed provided that staff radiologist at MD Anderson consider the quality of the study optimal to make a definitive diagnosis regarding myometrial invasion
- Patients must have <50% myometrial invasion on preoperative MRI
- Patients must have disease confined to either anterior or posterior wall of the uterus
- Ability to understand and the willingness to sign a written Informed Consent Document (ICD).
Exclusion Criteria:
- Patients with invasive uterine disease (>50% invasion) by preoperative MRI
- Patients with a diagnosis of leiomyomata affecting the endometrium
- Patients with a prior history of endometrial ablation
- Patients with multifocal disease within the uterus on preoperative MRI
- Patients with polypoid tumors protruding through the endocervical canal
- Patients with histology other than endometrioid adenocarcinoma
- Patients who have undergone a prior D&C for diagnosis of endometrial cancer
- Patients with exposure to metformin within 6 months of endometrial cancer diagnosis or at the time of diagnosis
- Patients < 18 years of age
- Patients with a known allergy to proflavine or acriflavine
- Patients that are pregnant or nursing
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
- 主な目的：処理
- 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 |
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実験的：Hysteroscope Imaging
All patients entered in study will undergo cervical dilation after induction of general anesthesia.
Once the cervix has been dilated, a hysteroscope will be introduced in the uterine cavity to evaluate for presence of tumor.
Location and size of tumor documented.
White-light images obtained using the High-Resolution Microendoscopy (HRME) camera introduced through the hysteroscope.
Once completed; the hysteroscope will be removed and the uterine cavity will be infused with 10 mL of proflavine (an acridine dye) (0.01% Proflavine (10ml)).
A resectoscope will then be introduced in the uterine cavity and fluorescent images obtained using the HRME camera.
The resectoscope will then be used to remove all tumor as guided through HRME images.
The entire imaging and tumor resection process is estimated to take 45 minutes or less.
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Once the cervix has been dilated, a hysteroscope will be introduced in the uterine cavity to evaluate for presence of tumor.
Location and size of tumor documented.
White-light images obtained using the HRME camera introduced through the hysteroscope.
Once completed; the hysteroscope will be removed and the uterine cavity will be infused with 10 mL of proflavine (an acridine dye) (0.01% Proflavine (10ml)).
A resectoscope will then be introduced in the uterine cavity and fluorescent images obtained using the HRME camera.
他の名前：
After hysteroscopy with HRME camera, uterine cavity infused with 10 mL of Proflavine.
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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 |
|---|---|---|
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Absence of Residual Disease in Hysterectomy Specimen
時間枠：1 day
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Descriptive statistics used to summarize the expression in tumor tissue and in normal tissue for each of the molecular markers assessed, as well as the difference in tumor and normal tissue within patient.
Paired t-test used to compare the tumor and normal tissue with respect to the mean difference in expression of each marker, pairing tumor and normal tissue on patient.
Boxplots used to illustrate the distribution of the difference in expression in tumor and normal tissue for each marker.
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1 day
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協力者と研究者
協力者
捜査官
- 主任研究者：Pedro Ramirez, MD、M.D. Anderson Cancer Center
出版物と役立つリンク
研究記録日
主要日程の研究
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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