Status:
TERMINATED
[18F]Fluoro-PEG-folate PET/CT Imaging in Epithelial Ovarian Cancer
Lead Sponsor:
Lioe-Fee de Geus-Oei, MD PhD
Collaborating Sponsors:
Amsterdam UMC, location VUmc
Centre for Human Drug Research, Netherlands
Conditions:
Epithelial Ovarian Cancer
Eligibility:
FEMALE
30+ years
Phase:
PHASE1
Brief Summary
The pre-operative assessment of intra-abdominal tumor load in patients with epithelial ovarian cancer (EOC) remains unreliable with standard imaging modalities. The use of tumor targeted imaging, such...
Eligibility Criteria
Inclusion
- Patients with radiologically FIGO stage IIIB/IIIC EOC based on the conventional CT scan who are:
- scheduled to undergo primary cytoreductive surgery and
- in whom EOC is histologically proven, or
- 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
- in whom EOC is histologically proven, or
- in whom EOC is cytologically suspected and a serum CA125/CEA ratio \> 25 was found before NACT
- and with radiologically FIGO stage IIIB/IIIC EOC based on the response evaluation CT scan after NACT
Exclusion
- Women younger than 30 years of age (in accordance with the guidelines of the Netherlands Commission on Radiation Dosimetry \[23\], as the total radiation dose will be 7.2 mSv)
- Patients who previously underwent primary laparotomy and in whom complete or optimal cytoreduction was not considered feasible.
- Contraindication for PET (pregnancy, lactating or severe claustrophobia)
- Thrombocytopenia (platelet count \< 100 x 10\^9/L) and/or INR \> 2
- Impaired renal function (defined as eGFR \< 50 mL/1.73 m2)
- Impaired liver function (ALT, AST or total bilirubin \> 3x upper limit of normal)
- Clinically significant abnormalities on ECG and/or clinically laboratory test
- Inability to tolerate lying supine for the duration of a PET/CT examination (\~110 minutes)
- 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
- Patients not able to comply with the study procedures
- Patients who did not give informed consent
Key Trial Info
Start Date :
May 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT05215496
Start Date
May 10 2022
End Date
May 1 2023
Last Update
March 15 2024
Active Locations (1)
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1
Katja Gaarenstroom
Leiden, South Holland, Netherlands, 2333 ZA