[18F]fluoro-PEG-folate PET/CT imaging in patients with epithelial ovarian cancer
- Conditions
- Epithelial ovarian cancer10033283
- Registration Number
- NL-OMON52813
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
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
found
or
• 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
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
normal)
7. Clinically significant abnormalities on ECG and/or clinically laboratory
test
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method