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临床试验/NCT06676943
NCT06676943已完成不适用

A Single Centre Pilot Study Investigating the Diagnostic Performance of High-resolution Specimen PET-CT in Determining Margin Status in Cancer Resection

University Hospitals Coventry and Warwickshire NHS Trust1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2024年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
1
主要终点
To assess the accuracy of intra-operative high-resolution surgical specimen PET-CT (XEOS Aura 10) in determining margin status during prostate cancer resection, and head and neck cancer resection specimens compared to the reference gold standard.

研究概览

简要总结

Surgical removal is the treatment for many different cancers. Patient outcomes depend on complete cancer removal with no tumour present at the edge of the section removed (specimen). If cancer is left behind, then patients might need additional cancer treatment. Regardless of whether extra treatment is required, knowing that removal was incomplete causes anxiety. The need for a wide removal of the tumour must be balanced against the harm caused by more extensive surgery particularly when important organs and structures are close by. The fact that the cancer is not visible to the surgeon during the operation means that there is an element of guesswork when deciding how much tissue to remove. This study is examining a technique that the investigators hope will provide surgeons with more precise information about how much tissue to remove during cancer operations using a new type of Positron Emission Tomography-Computed Tomography (PET-CT) scanner. Patients with different types of cancer (e.g. prostate, head and neck cancer) will be injected with a small amount of radioactive tracer at the beginning of their cancer operation. This tracer will attach itself to the cancer cells. Once the surgical specimen is removed it will be placed into the specimen PET-CT scanner so that the surgeon can see the cancer within the specimen. The investigators will then compare the results of the scan of the specimen taken during the operation with the results when the whole specimen has been examined under the microscope. Examination under the microscope is considered to be the gold standard for deciding whether the cancer removal operation has been successful. This study aims to tell us how accurate the new specimen PET-CT scanner results are, and so whether or not surgeons can rely on the results to guide them during operations in the future.

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

  • For prostate cancer patients:
  • At least 18 years old at time of consent.
  • Listed for Robotic Radical Prostatectomy.
  • For head and neck cancer patients:
  • At least 18 years old at time of consent.
  • Listed for resection of oral squamous cell carcinoma head and neck cancer resection.
  • Specimen able to fit into Xeos Aura specimen container.

排除标准

  • For prostate cancer patients:
  • General or local contra-indications for resectional surgery.
  • Lacks capacity to provide informed consent.
  • Currently participating in another interventional research study that in the judgment of the investigator would negatively affect the participant and/or this study's data integrity.
  • For head and neck cancer patients:
  • General or local contra-indications for resectional surgery.
  • Lacks capacity to provide informed consent.
  • Pregnant or breast feeding patient.
  • Currently participating in another interventional research study that in the judgment of the investigator would negatively affect the participant and/or this study's data integrity.

研究组 & 干预措施

Radical prostatectomy and Head and neck specimens

Experimental

Patients undergoing surgical resection for prostate cancer or head and neck cancer.

干预措施: XEOS AURA 10 specimen PET-CT scan of tumour specimens (Procedure)

结局指标

主要结局

To assess the accuracy of intra-operative high-resolution surgical specimen PET-CT (XEOS Aura 10) in determining margin status during prostate cancer resection, and head and neck cancer resection specimens compared to the reference gold standard.

时间窗: Up to 8 weeks after the day of surgery when the histopathological margin status result is recorded.

The true gold standard is whether the cancer is on the margin (positive) or not (negative) as per specimen PET-CT compared to the gold standard radical prostatectomy histopathological margin status, and head and neck cancer resection specimen.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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