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临床试验/NCT06144853
NCT06144853已完成不适用

FDG-PET/CT as a Method of Patient Selection and Response Evaluation in Patients With Peritoneal Metastasis Treated With Pressurized IntraPeritoneal Aerosol Chemotherapy. A Pilot Study

Odense University Hospital1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
The number of patients with metabolic response according to FDG-PET/CT evaluated by PERCIST 1.0 one lesion after PIPAC 3

研究概览

简要总结

The pilot study will investigate the use of repeated FDG-PET/CT scans in 16 patients with peritoneal metastasis originating from abdominal cancers treated with Pressurized Intraperitoneal Aerosol Chemotherapy. The study will focus on the potential of repeated FDG-PET/CT scans to evaluate the treatment as well as the feasibility in the patient group.

详细描述

Background: Peritoneal metastasis (PM) is a late-stage manifestation of several gastro-intestinal cancers. Conventional administrated chemotherapy has limited effect due to the peritoneal-plasma barrier and most patients will die from their disease within a few months. An alternative treatment strategy, Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC), has gained interest in the last decade. Prospective phase II studies have demonstrated significant local treatment effect and promising survival data initially within the palliative setting but more recently also with curative intent. The technical aspects of PIPAC are nearly uniform worldwide but there is no consensus on the optimal evaluation of treatment response. Currently, histological features in repeated biopsies from the peritoneum are used as an indicator of treatment response. Thus, easily accessible, and non-invasive alternatives are needed to optimize and personalize patient selection and to improve the response assessment. Both are also essential regarding future development and implementation of this treatment for both curative and palliative purposes. This could be achieved with the use of imaging techniques. Computed tomography (CT) scan holds well-known limitations in the detection of PM. Alternatively, several studies have investigated the use of the Positron emission tomography and CT (PET/CT) scans in the diagnostic setting of PM. This method shows promising results concerning visualization and assessing PM lesions, but no studies have investigated the ability of PET/CT scans to detect changes in PM during PIPAC treatment. Enabling the use of PET/CT scans as an evaluation tool for PIPAC-directed therapy is an important and necessary step to expand the clinical application. Also, non-invasive evaluation methods and consensus of evaluation is of significant importance for the quality of future randomized controlled trials in this field of research. We want to conduct a prospective study to investigate if PET/CT scans can detect changes within PM lesions in patients treated with PIPAC directed therapy. Since the study is the first of its kind, we plan to start with a pilot study including only a few patients. We will use the results to generate important knowledge for subsequent larger randomized studies on and clinical optimization of PIPAC directed therapy in patients with PM.

Objective

To investigate whether FDG-PET/CT scans can detect changes in PM in patients treated with PIPAC and whether the repeated scans are feasible within this group of patients.

Method: The pilot study will include 16 patients with known PM, four from each of the groups: gastric cancer, pancreatic cancer, colo-rectal cancer and ovarian cancer will be included. The patient will be offered standard PIPAC directed treatment (including standard histological evaluation of biopsies of the peritoneum) according to local guidelines. During the first series (one series is equivalent to three PIPAC treatments each five weeks) patients will receive three FDG-PET/CT's, one before PIPAC 1, one after PIPAC 2 and one after PIPAC 3. The scans will be described according to PERCIST (PET response criteria in solid tumors). In case of FDG-negative PM-disease at the first scan the patient will receive only one follow-up scan after PIPAC 2 to investigate whether the treatment if self can cause FDG-uptake in the PM elements.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patients with synchronous or metachronous histology or cytology proven GC, PC, CRC, or OC with clinical evidence of PM.
  • Patients who are eligible for and offered PIPAC at the discretion of the dedicated multidisciplinary tumor conference and subsequent out-patient evaluation at Odense PIPAC Center
  • Patients with a maximum of one extra-peritoneal metastasis at CT dated within one month of inclusion.
  • Patients in Eastern Cooperative Oncology Group performance status 0-
  • Patients >18 years of age.
  • Patients must be able to give mandatory oral and written consent in Danish.

排除标准

  • Concomitant systemic chemotherapy (bidirectional treatment).
  • Known allergies to contrast dye.
  • Any other significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the trial, or may influence the results.

结局指标

主要结局

The number of patients with metabolic response according to FDG-PET/CT evaluated by PERCIST 1.0 one lesion after PIPAC 3

时间窗: 18 months

The number of patients with metabolic response according to FDG-PET/CT evaluated by PERCIST 1.0 one lesion after PIPAC 3

次要结局

  • The number and reasons for discontinued FDG-PET/CT scans (feasibility)(18 months)
  • The number of patients with metabolic response after PIPAC 1 according to FDG-PET/CT evaluated by PERCIST 1.0(18 months)
  • Number of patients with FDG-PET/CT positive peritoneal surface after PIPAC 1 despite negative baseline FDG-PET/CT (false positive/feasibility)(18 months)
  • The number of patients where FDG-PET/CT evaluated by PERCIST one lesion agrees with histological response according to PRGS after PIPAC 1 and 3(18 months)
  • The number of patients with changed treatment strategy due to extraperitoneal FDG-PET/CT findings after PIPAC 1 or PIPAC 3(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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