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临床试验/NL-OMON52813
NL-OMON52813已完成不适用

[18F]fluoro-PEG-folate PET/CT imaging in patients with epithelial ovarian cancer - [18F]fluoro-PEG-folate PET/CT imaging in epithelial ovarian cancer

eids Universitair Medisch Centrum0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • Patients with radiologically FIGO stage IIIB/IIIC EOC based on the conventional
  • CT scan who are
  • scheduled to undergo primary cytoreductive surgery and
  • a) in whom EOC is histologically proven, or
  • b) in whom EOC is cytologically suspected and a serum CA125/CEA ratio > 25 is
  • treated with neoadjuvant chemotherapy (NACT) and are scheduled to undergo
  • interval cytoreductive surgery and
  • a) in whom EOC is histologically proven, or
  • b) in whom EOC is cytologically suspected and a serum CA125/CEA ratio > 25 was
  • found before NACT
  • c) and with radiologically FIGO stage IIIB/IIIC EOC based on the response
  • evaluation CT scan after NACT

排除标准

  • 1. Women younger than 30 years of age (in accordance with the guidelines of the
  • Netherlands Commission on Radiation Dosimetry, as the total radiation dose will
  • be 7.2 mSv)
  • 2. Patients who previously underwent primary laparotomy and in whom complete or
  • optimal cytoreduction was not considered feasible.
  • 3. Contraindication for PET (pregnancy, lactating or severe claustrophobia)
  • 4. Thrombocytopenia (platelet count < 100 x 10^9/L) and/or INR > 2
  • 5. Impaired renal function (defined as eGFR < 50 mL/1.73 m2)
  • 6. Impaired liver function (ALT, AST or total bilirubin > 3x upper limit of
  • 7. Clinically significant abnormalities on ECG and/or clinically laboratory
  • 8. Inability to tolerate lying supine for the duration of a PET/CT examination
  • (~110 minutes)
  • 9. Patients with concomitant malignancy (except basal cell carcinoma of the
  • skin) or any condition that in the opinion of the investigators could
  • potentially jeopardize the health status of the patient
  • 10. Patients not able to comply with the study procedures
  • 11. Patients who did not give informed consent

研究者

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