Pilot Study of TumorGlow for Intraoperative Molecular Imaging of Sarcoma Metastases to the Lungs in Pediatric Patients (TumorGlow)
調査の概要
詳細な説明
This is a phase 1 single dose, open-label study to determine the safety of a single 5 mg/kg dose of ICG (TumorGlow) used with Near Infrared (NIR) fluorescent for pediatric subjects with suspected metastatic sarcoma to the lung scheduled to undergo thoracic surgery per CT/PET or other imaging based on standard of care.
Following the screening visit to confirm eligibility, subject assent and parental/legal guardian consent for enrollment will be obtained prior to commencement of any study procedures. The screening period will be up to 60 days prior to ICG infusion. All subjects enrolled will be infused with 5 mg/kg ICG intravenously up to 5-days prior to the planned surgery (Day 0).
After ICG infusion is completed (Day 0), subjects during the surgery will undergo white light evaluation and/or palpation, and the number and the location of all suspicious nodules and lesions identified in this step will be recorded as such following the study procedure guideline as described in  (Day 1). Following white light assessment, but prior to any surgical removal of lesions/nodules, subjects will undergo assessment with NIR fluorescent light imaging to localize any lesions or nodules.
All identified lesions will be removed as determined by the surgeon. All removed lesions identified either using white light, NIR imaging or both will be documented as such and examined back table for fluorescence under NIR imaging including margin status. Positive margins are defined as fluorescent areas identified within (less than or equal to) 5mm of the inside staple line by back table measurement. Following the resection and prior to closing the subject, the field will be illuminated with the imaging system again to detect and remove any remaining fluorescence positive nodules. All specimens removed after the back table examination will be sent to pathology for evaluation including margin status by a pathologist that is blinded to the fluorescent status of lesions or nodules.
研究の種類
入学 (推定)
段階
- 初期フェーズ 1
連絡先と場所
研究連絡先
- 名前：Peter Mattei, MD
- 電話番号：(215)-590-2730
- メール：mattei@email.chop.edu
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 1. Male and female children (12 - 17 years of age) with a primary diagnosis, or a high clinical suspicion of a solid tumor with metastasis to the lung warranting surgery based on CT/PET or other imaging 2. Are scheduled to undergo surgical resection for suspected metastasis 3. Female subjects of childbearing potential (including those less than 2 years postmenopausal) agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after infusion of ICG. Male subjects who are are sexually active (and capable of producing sperm) with a partner that could become pregnant, must agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after infusion of ICG.
Exclusion Criteria:
1. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject 2. History of anaphylactic reactions to ICG. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation 3. A positive serum pregnancy test at screening for female subjects of childbearing potential. Note that subjects with a positive pregnancy test on the day of infusion will be discontinued from study and will not receive the study drug.
4. Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol and follow-up schedule 5. Impaired liver function defined as values > 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT),aspartate aminotransferase (AST), or alkaline phosphatase (ALP), or >2x ULN for total bilirubin except in subjects with Gilbert's syndrome. *For subjects with Gilbert's syndrome, total bilirubin levels exceeding 3 mg/dL will be excluded.* 6. Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to the administration of study drug 7. History of uncontrolled hypertension. (e.g., history of an emergency room [ER] admission for hypertensive crisis or ≥ 3 BP medications) 8. Known sensitivity to fluorescent light
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 |
|---|---|
|
実験的：Single Dose 5mg/kg
Subjects will undergo infusion of 5 mg/kg indocyanine green, ICG ("TumorGlow") intravenously up to 5-days prior to surgery.
|
Subjects will undergo infusion of 5 mg/kg indocyanine green, ICG ("TumorGlow") intravenously up to 5-days prior to surgery.
|
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 |
|---|---|---|
|
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
時間枠：1 year
|
To assess the safety and tolerability of intravenously infusion of a single dose 5 mg/kg of ICG; 2. To assess the safety and tolerability of using high dose (5 mg/kg) ICG used with Near Infrared (NIR) fluorescent imaging when used with ICG in subjects undergoing pulmonary metastasectomy.
Safety will be assessed by the incidence of AEs and SAEs coded using MedDRA.
Results will be summarized as the number and percentage of participants with events, categorized by preferred term, system organ class, severity grade, attribution, and timing relative to infusion and surgery.
AE rates will be reported with one-sided 90% exact confidence intervals and compared against a 25% unacceptable safety threshold.
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1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sensitivity of INR
時間枠：1 year
|
The following secondary efficacy endpoints are only defined for FAS subjects, i.e., subjects undergoing NIR fluorescent imaging with ICG for the detection of primary nodules and/or synchronous lesions
|
1 year
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 25-023410
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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