68Ga-FAPI PET/CT in the Staging of High-Grade Epithelial Ovarian Cancers: A Pilot Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Health Network, Toronto
About this trial
The investigator will use a technology called PET-CT that combines a Positron Emission Tomography (PET) scan with a computed tomography (CT) scan. This combined imaging test, where PET and CT data are gathered at one time, will be performed on an integrated PET-CT scanner located at Princess Margaret Cancer Centre.
The purpose of this study is to find out if the use of 68Ga-PNT6555 (FAPI) PET-CT will improve the assessment of disease extent as compared to routine CT scans.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Cytological or histological diagnosis of HGSOC, or clinical suspicion of HGSOC based on symptoms, physical exam, tumour markers, and imaging findings.
Clinical stage III or IV, being considered for PCS or NACT.
Contrast-enhanced CT abdomen and pelvis within 6 weeks of PET (prior to enrolment).
Disqualifiers
Inability to provide informed consent.
Contraindications for PET examination as per institutional safety guidelines, including but not limited to pregnancy, or inability to lie still for PET examination.
Evidence of the following epithelial ovarian cancer histological subtypes: Mucinous, low-grade serous, low-grade endometrioid, and low-malignant potential tumours.
Non-ovarian advanced gynecological malignancy
Trial design
Design model
Single group
Treatments tested in this trial
FAPI PET CT
Radiationthe utilization of Gallium 68 labelled Fibroblast Activation Protein Inhibitor (68Ga-FAPI) PET/CT to accurately stage high-grade epithelial ovarian cancers.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: high-grade epithelial ovarian cancers.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
FAPI positivity
A lesion will be considered abnormal when focal tracer accumulation is greater than background activity and cannot be attributed to a physiological or benign entity.FAPI tumour volumes will be correlated with clinical outcome measures including: 1. Achievement of optimal or complete cytoreduction; 2. Progression-free survival (PFS); 3. Overall survival (OS).
Time frame
through study completion, an average of 1 year2
Quantitative parameters
Comparison of tracer uptake (SUVmax/mean) in a lesion to reference tissues (blood pool, liver); calculation of ratio of lesion SUV/ reference tissues.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Modality performance measures (CT vs PET)
Sensitivity, specificity, Negative Predictive Value (NPV), Positive Predictive Value (PPV) and validity will be calculated for each modality according to the reference standard (surgery and surgical histopathology) for all evaluable lesions.
Time frame
through study completion, an average of 1 year2
Frequency of AE's
Safety Measurements
Time frame
through study completion, an average of 1 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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