Back to results[18F]Fluoro-PEG-folate PET/CT Imaging in Epithelial Ovarian Cancer
Primary Purpose
Epithelial Ovarian Cancer
Status
Recruiting
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
[18F]fluoro-PEG-folate PET/CT scan
Sponsored by
About this trial
This is an interventional diagnostic trial for 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
- 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 Criteria:
- 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
Sites / Locations
- Leiden University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[18F]fluoro-PEG-folate PET/CT scan
Arm Description
Patients with FIGO stage IIIB/IIIC epithelial ovarian cancer, 185 MBq of [18F]fluoro-PEG-folate.
Outcomes
Primary Outcome Measures
Tolerability of the [18F]fluoro-PEG-folate PET tracer
To assess the tolerability of the [18F]fluoro-PEG-folate PET tracer vital signs will be recorded every 15 minutes starting directly before administration and continued up to two hours after dosing. The endpoint for this study is the number of patients whose vital signs stayed within a normal range of their baseline.
Arterial plasma input curve of the [18F]fluoro-PEG-folate tracer
Blood samples will be collected to determine the arterial plasma input curve of the tracer.
Pharmacokinetic distribution of the [18F]fluoro-PEG-folate tracer
Blood samples will be collected to determine the pharmacokinetic distribution of the tracer.
Safety of the [18F]fluoro-PEG-folate PET tracer
Total number of AEs and SAEs that occur during the observation period.
Secondary Outcome Measures
Sensitivity and specificity
Sensitivity and specificity of the FR-targeted PET/CT scan for the detection of metastatic EOC lesions. Postoperative histopathology will serve as the gold standard.
Full Information
NCT ID
NCT05215496
First Posted
September 1, 2021
Last Updated
August 17, 2022
Sponsor
Lioe-Fee de Geus-Oei, MD PhD
Collaborators
Amsterdam UMC, location VUmc, Centre for Human Drug Research, Netherlands, The Netherlands Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT05215496
Brief Title
[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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
November 25, 2022 (Anticipated)
Study Completion Date
November 25, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lioe-Fee de Geus-Oei, MD PhD
Collaborators
Amsterdam UMC, location VUmc, Centre for Human Drug Research, Netherlands, The Netherlands Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
[18F]fluoro-PEG-folate PET/CT scan
Arm Type
Experimental
Arm Description
Patients with FIGO stage IIIB/IIIC epithelial ovarian cancer, 185 MBq of [18F]fluoro-PEG-folate.
Intervention Type
Diagnostic Test
Intervention Name(s)
[18F]fluoro-PEG-folate PET/CT scan
Intervention Description
A dynamic FR-targeted PET scan, a low-dose CT scan without contrast agents, and a static FR-targeted PET scan will be obtained
Primary Outcome Measure Information:
Title
Tolerability of the [18F]fluoro-PEG-folate PET tracer
Description
To assess the tolerability of the [18F]fluoro-PEG-folate PET tracer vital signs will be recorded every 15 minutes starting directly before administration and continued up to two hours after dosing. The endpoint for this study is the number of patients whose vital signs stayed within a normal range of their baseline.
Time Frame
From administration up to two hours after administration
Title
Arterial plasma input curve of the [18F]fluoro-PEG-folate tracer
Description
Blood samples will be collected to determine the arterial plasma input curve of the tracer.
Time Frame
At regular intervals up to 90 minutes post injection of the tracer.
Title
Pharmacokinetic distribution of the [18F]fluoro-PEG-folate tracer
Description
Blood samples will be collected to determine the pharmacokinetic distribution of the tracer.
Time Frame
At regular intervals up to 90 minutes post injection of the tracer.
Title
Safety of the [18F]fluoro-PEG-folate PET tracer
Description
Total number of AEs and SAEs that occur during the observation period.
Time Frame
Up to six weeks after the injection of the tracer.
Secondary Outcome Measure Information:
Title
Sensitivity and specificity
Description
Sensitivity and specificity of the FR-targeted PET/CT scan for the detection of metastatic EOC lesions. Postoperative histopathology will serve as the gold standard.
Time Frame
Up to 6 weeks after the FR-targeted PET/CT scan.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
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 Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lioe-Fee de Geus-Oei, MD, PhD
Phone
+31715263480
Email
l.f.de_geus-oei@lumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Isabeau T Ciggaar, MD
Phone
+31715263480
Email
i.a.ciggaar@lumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lieo-Fee de Geus-Oei, MD, PhD
Organizational Affiliation
LUMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leiden University Medical Center
City
Leiden
State/Province
Zuid-holland
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabeau A Ciggaar, MD
Phone
+31715263480
Email
i.a.ciggaar@lumc.nl
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
[18F]Fluoro-PEG-folate PET/CT Imaging in Epithelial Ovarian Cancer
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