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

Phase 1

• Conditions: Epithelial ovarian cancer (EOC); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-000112-29-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-27
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 15

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 [2,22] 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 [2,22] was found before NACT
c)and with radiologically FIGO stage IIIB/IIIC EOC based on the response evaluation CT scan after NACT

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

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. Impaired renal function (defined as eGFR < 50 mL/1.73 m2)
5. Impaired liver function (ALT, AST or total bilirubin > 3x upper limit of normal)
6. Clinically significant abnormalities on ECG and/or clinically laboratory test
7. Inability to tolerate lying supine for the duration of a PET/CT examination (~110 minutes)
8. 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
9. Patients not able to comply with the study procedures
10. Patients who did not give informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified