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临床试验/NCT04752137
NCT04752137招募中2 期

Evaluation of Intraoperative Tumor Margin Identification With Fluorescent Dye Imaging

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年5月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
入组人数
100
试验地点
2
主要终点
image-guided prediction of local recurrence

研究概览

简要总结

In this research study we want to learn more about the use of indocyanine green (ICG) during bone or soft tissue mass resections. Indocyanine green (ICG) is a type of dye that is used in medical diagnostics. We want to determine if ICG-guided tumor resection is more effective in obtaining negative margins. Lastly, we want to assess traditional oncologic outcomes of local recurrence, time to metastatic disease, and overall and disease specific survival.

详细描述

If you are present for a preoperative clinic visit the day before your surgery, ICG may be administered via injection. Otherwise, ICG will be administered in the preoperative unit via IV injection at the time of presentation approximately 4 hours before your surgery. You will be monitored during and after ICG dosing.

During surgery ICG fluorescence using a near-infrared imager will be performed at the time of and immediately following primary tumor resection. The imager will evaluate the primary tumor to ensure appropriate tumor fluorescence. Once the primary resection is complete and the surgeon believes that he/she has achieved negative or planned positive margins, fluorescence measurements of the tumor bed will be performed. If areas of positive signal remain, these areas will be resected if possible and sent to pathology for histologic evaluation. It will be recorded if the surgeon perceived negative margins but the device detected positive margins.

Tumor specimens and residual fluorescence positive samples will be evaluated using fresh frozen and permanent histology. Permanent samples will be evaluated for tumor and local fluorescence using confocal microscopy with an ICG cube. Positive fluorescence signal and its correspondence with neoplasm will be noted, a will tumor that does not fluoresce.

Tissue being removed is 1-2 mm from non-structurally important tissue that either has or does not have signal positivity for additional pathologic assessment. It should have no impact on patient outcome, does not represent intervention on sensitive areas (such as neurovascular structures), and can further be used as potential margin around the tumor.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients 18 years of age or older who present to Massachusetts General Hospital Department of Orthopaedic Surgery with a benign or malignant bone or soft tissue mass that is consented for surgery during the study period.

排除标准

  • Pregnant or nursing patients
  • Patients with previously known anaphylaxis to IV contrast or iodine (other allergies may be considered on a case-by-case basis)
  • Patients in renal failure who are not cleared for ICG administration by their primary physician or oncologist

研究组 & 干预措施

ICG Dye and use of SPY-PHI Imaging

Other

ICG will be administered in the pre-operative unit via IV injection at the time that they present to the pre-operative unit, which is approximately 4 hours before surgery. ICG Angiography (SPY PHI) will be performed to detect any residual signal

干预措施: SPY-PHI (Device)

ICG Dye and use of SPY-PHI Imaging

Other

ICG will be administered in the pre-operative unit via IV injection at the time that they present to the pre-operative unit, which is approximately 4 hours before surgery. ICG Angiography (SPY PHI) will be performed to detect any residual signal

干预措施: Indocyanine green (Drug)

结局指标

主要结局

image-guided prediction of local recurrence

时间窗: 2 Years

The primary outcome of this work is image-guided prediction of local recurrence, defined as pathologically confirmed return of the resected tumor local to the prior excision bed within 2 years of the primary surgery.

次要结局

  • Distant recurrence (metastatic disease)(2 Years)
  • physician-perceived vs. device measured negative margins(14 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Santiago Lozano-Calderon

Assistant Professor of Orthopaedic Surgery

Massachusetts General Hospital

研究点 (2)

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