Indocyanine Green (ICG) Guided Tumor Resection
キーワード
概要
説明
This trial is a single center open-label study. Patients with a solid tumor or lymphoma who require resection either for therapeutic or diagnostic intent will be included.
Indocyanine Green (ICG) is an FDA-approved drug. The day before the surgery, patients will receive a single dose of ICG intravenously. Surgery will be performed the following day.
During surgery, after the surgeon identifies the mass through visual (seen with the naked eye) and or tactile methods (palpated), the patient will have his/her tumor field imaged by Iridium system optimized for detection of ICG (Visionsense Corp, Philadelphia, PA). The entire procedure will be photo- documented and recorded.
The Visionsense system records images in real time, calculates percentages, and captures the data. At least three different areas of the tumor will be measured. If the tumor cannot be identified by visual inspection or palpation, NIR-imaging will be used in an attempt to locate the lesion. The surrounding area will be inspected and measured to screen for additional sites of metastatic disease. After tumor resection, residual fluorescence in the surgical resection bed will be measured.
Direct subject participation in the trial will last for the period of time from injection of the ICG the day before surgery and until 24 hours post-surgery.
日付
| 最終確認済み: | 03/31/2020 |
| 最初に提出された: | 09/03/2019 |
| 提出された推定登録数: | 09/08/2019 |
| 最初の投稿: | 09/09/2019 |
| 最終更新が送信されました: | 04/26/2020 |
| 最終更新日: | 04/27/2020 |
| 実際の研究開始日: | 02/06/2020 |
| 一次完了予定日: | 12/30/2022 |
| 研究完了予定日: | 12/30/2022 |
状態または病気
介入/治療
Drug: Indocyanine green (ICG)
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: Indocyanine green (ICG) Participants will receive a single dose of 1.5 mg/kg of ICG intravenously over 15 minutes the day before surgery. | Drug: Indocyanine green (ICG) IV |
適格基準
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: - Patients with a primary or relapsed solid tumor or lymphoma who require excision of the tumor or metastatic lesions. Exclusion Criteria: - Subjects with a history of iodide allergies, including positive allergic reaction to the screening iodine test. - Inability or unwillingness of research participant or legal guardian/representative to give written informed consent. - Patients with benign pathology. - Patients with brain tumors. - Pregnant female. |
結果
主な結果の測定
1. Sensitivity and specificity rates of the ICG guided neoplastic disease identification [up to 24 hours post-surgery]
