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Clinical Trials/NL-OMON52813
NL-OMON52813
Completed
Not Applicable

[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 sites15 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epithelial ovarian cancer
Sponsor
eids Universitair Medisch Centrum
Enrollment
15
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Not specified

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