Clinical trial NCT05215496: [18F]Fluoro-PEG-folate PET/CT Imaging in Epithelial Ovarian Cancer
Official title: [18F]Fluoro-PEG-folate PET/CT Imaging in Epithelial Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Epithelial Ovarian Cancer
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Amsterdam UMC, location VUmc
name: Centre for Human Drug Research, Netherlands
name: The Netherlands Cancer Institute
First posted: 2022-01-31
Enrollment: 5
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 185 MBq of \[18F\]fluoro-PEG-folate PET tracer will be intravenously administered to 15 patients with radiologically advanced stage EOC who are scheduled to undergo cytoreductive surgery, after which an FR-targeted PET/CT will be made. FR-targeted PET/Ct results will be compared to the intraoperative findings, postoperative histopathology (gold standard) and the conventional CT scan.
Primary purpose: DIAGNOSTIC

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 as folate receptor (FR)-targeted positron emission tomography (PET) imaging could aid in the preoperative assessment of metastatic tumor load.

This study aims to evaluate the safety and tolerability, and pharmacokinetics of the \[18F\]fluoro-PEG-folate PET tracer and to assess the sensitivity and specificity of a \[18F\]fluoro-PEG-folate PET/CT scan for the preoperative detection of intra-abdominal metastatic lesions in patients with advanced stage epithelial ovarian cancer.


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

  1. in whom EOC is histologically proven, or
  2. 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

  1. in whom EOC is histologically proven, or
  2. in whom EOC is cytologically suspected and a serum CA125/CEA ratio \> 25 was found before NACT
  3. and with radiologically FIGO stage IIIB/IIIC EOC based on the response evaluation CT scan after NACT

Exclusion Criteria:

1. 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)
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

Primary outcomes:
measure: Tolerability of the [18F]fluoro-PEG-folate PET tracer
timeFrame: From administration up to two hours after administration
measure: Arterial plasma input curve of the [18F]fluoro-PEG-folate tracer
timeFrame: At regular intervals up to 90 minutes post injection of the tracer.
measure: Pharmacokinetic distribution of the [18F]fluoro-PEG-folate tracer
timeFrame: At regular intervals up to 90 minutes post injection of the tracer.
measure: Safety of the [18F]fluoro-PEG-folate PET tracer
timeFrame: Up to six weeks after the injection of the tracer.
Secondary outcomes:
measure: Sensitivity and specificity
timeFrame: Up to 6 weeks after the FR-targeted PET/CT scan.
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Katja Gaarenstroom
state: Zuid-holland
Study officials:
affiliation: LUMC
name: Lioe-Fee de Geus-Oei, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: