Epithelial Ovarian CancerPhase 1NCT05215496
[18F]Fluoro-PEG-folate PET/CT Imaging in Epithelial Ovarian Cancer
A Phase 1 study testing [18F]fluoro-PEG-folate PET/CT scan in people with Epithelial Ovarian Cancer, run by Lioe-Fee de Geus-Oei, MD PhD at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- [18F]fluoro-PEG-folate PET/CT scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 May 2022to 1 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- [18F]fluoro-PEG-folate PET/CT scan
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]fluoro-PEG-folate PET/CT scanDiagnostic test
A dynamic FR-targeted PET scan, a low-dose CT scan without contrast agents, and a static FR-targeted PET scan will be obtained
| Study group | Role | What they receive |
|---|---|---|
| [18F]fluoro-PEG-folate PET/CT scan | Experimental | Patients with FIGO stage IIIB/IIIC epithelial ovarian cancer, 185 MBq of [18F]fluoro-PEG-folate. Receives: Diagnostic Test: [18F]fluoro-PEG-folate PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From administration up to two hours after administration
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.
Measured: At regular intervals up to 90 minutes post injection 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.
Measured: At regular intervals up to 90 minutes post injection of the tracer.
Safety of the [18F]fluoro-PEG-folate PET tracer
Total number of AEs and SAEs that occur during the observation period.
Measured: Up to six weeks after the injection of the tracer.
Secondary outcomes (1)
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.
Measured: Up to 6 weeks after the FR-targeted PET/CT scan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start10 May 2022
- Primary completion1 May 2023
- Study completion1 May 2023
Why it stopped: Reached the stop criteria after the interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lioe-Fee de Geus-Oei, MD PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Centre for Human Drug Research, Netherlands, The Netherlands Cancer Institute
- Responsible party
- Sponsor-investigator, Lioe-Fee de Geus-Oei, MD PhD, Leiden University Medical Center
- Investigators
- Lioe-Fee de Geus-Oei, MD, PhD, Principal investigator, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215496
- Sponsor's protocol ID
- P20.048
- Other IDs
- 2020-000112-29, NL72618.058.20
- Status last verified
- Mar 2024
- First submitted
- 1 Sep 2021
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ciggaar IA, de Muynck LDAN, de Geus-Oei LF, van Velden FHP, de Kroon CD, Pereira Arias-Bouda LM, Noortman WA, van Persijn van Meerten EL, Dibbets-Schneider P, Helmerhorst HJF, Windhorst AD, Vahrmeijer AL, Peters ITA, Gaarenstroom KN. Preoperative [18F]fluoro-PEG-folate PET/CT in advanced stage epithelial ovarian cancer: A safety and feasibility study. Nucl Med Biol. 2024 Nov-Dec;138-139:108952. doi: 10.1016/j.nucmedbio.2024.108952. Epub 2024 Sep 19.
PubMed 39326323
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [18F]Fluoro-PEG-folate PET/CT Imaging in Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05215496
- Acronym / sponsor ID
- P20.048
- Conditions
- Epithelial Ovarian Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Reached the stop criteria after the interim analysis
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Lioe-Fee de Geus-Oei, MD PhDUniversity, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Centre for Human Drug Research, Netherlands, The Netherlands Cancer Institute
- Study start
- 10 May 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| [18F]fluoro-PEG-folate PET/CT scan | Experimental | Diagnostic Test: [18F]fluoro-PEG-folate PET/CT scanPatients with FIGO stage IIIB/IIIC epithelial ovarian cancer, 185 MBq of [18F]fluoro-PEG-folate. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with radiologically FIGO stage IIIB/IIIC EOC based on the conventional CT scan who are:
- scheduled to undergo primary cytoreductive surgery and
- or
- treated with neoadjuvant chemotherapy (NACT) and are scheduled to undergo interval cytoreductive surgery and
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]fluoro-PEG-folate PET/CT scanA dynamic FR-targeted PET scan, a low-dose CT scan without contrast agents, and a static FR-targeted PET scan will be obtained | Diagnostic test | [18F]fluoro-PEG-folate PET/CT scan |
Primary outcome
Tolerability of the [18F]fluoro-PEG-folate PET tracer
Time frame: From administration up to two hours after administration
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
Time frame: At regular intervals up to 90 minutes post injection of the 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
Time frame: At regular intervals up to 90 minutes post injection of the tracer.
Blood samples will be collected to determine the pharmacokinetic distribution of the tracer.
Safety of the [18F]fluoro-PEG-folate PET tracer
Time frame: Up to six weeks after the injection of the tracer.
Total number of AEs and SAEs that occur during the observation period.
1 secondary outcome
Sensitivity and specificity
Time frame: Up to 6 weeks after the FR-targeted PET/CT scan.
Results and safety
The study was stopped early (reason given: Reached the stop criteria after the interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 39326323Ciggaar IA, de Muynck LDAN, de Geus-Oei LF, van Velden FHP, de Kroon CD, Pereira Arias-Bouda LM, Noortman WA, van Persijn van Meerten EL, Dibbets-Schneider P, Helmerhorst HJF, Windhorst AD, Vahrmeijer AL, Peters ITA, Gaarenstroom KN. Preoperative [18F]fluoro-PEG-folate PET/CT in advanced stage epithelial ovarian cancer: A safety and feasibility study. Nucl Med Biol. 2024 Nov-Dec;138-139:108952. doi: 10.1016/j.nucmedbio.2024.108952. Epub 2024 Sep 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lioe-Fee de Geus-Oei, MD, PhD principal investigator
LUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [18F]fluoro-PEG-folate PET/CT scan in people with Epithelial Ovarian Cancer, run by Lioe-Fee de Geus-Oei, MD PhD at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Reached the stop criteria after the interim analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of the [18F]fluoro-PEG-folate PET tracer (time frame: From administration up to two hours after administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05215496, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.