Clinical trial NCT05903807: [68Ga]Ga-FAPI-46 PET/CT in Ovarian Cancer
Official title: [68Ga]Ga-FAPI-46 PET/CT: the Diagnostic Accuracy for Primary Staging and Re-staging of Patients with Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: Cancer
FAPI
FAPI PET/CT
Fibroblast activation protein inhibitor
Ovarian cancer
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Fifty consecutive patients newly diagnosed with ovarian cancer are recruited
Primary purpose: DIAGNOSTIC

Brief summary: Fifty (n=50) patients with newly diagnosed ovarian cancer will undergo FAPI PET/CTs in addition to routine diagnostic workup (including FDG PET/CT) at primary staging and restaging.

The FAPI PET/CT results will be compared to conventional imaging (including FDG PET/CT) using histopathology as reference standard, and the diagnostic accuracy will be determined. FAP-immunohistochemistry will be conducted in surgical specimens. FAPI PET/CT's impact on patient management and the prognostic value of FAPI PET/CT will be evaluated.

Detailed description: A new and promising PET-tracer in oncology has been developed; Gallium-68 labelled fibroblast activation protein inhibitor (FAPI). In general, FAPI PET/CT delivers increased sensitivity compared to 18F-Fluorodeoxyglucose (FDG) PET/CT in cancer types of mesenchymal origin (i.e., sarcomas), and in cancers characterized by a large proportion of stromal cells such as gastric and pancreatic cancers. It is currently debated whether FAPI PET/CT will take over FDG PET/CTs well-established role in oncological PET/CT, but more studies are needed to evaluate the diagnostic accuracy. The clinical interest in FAPI extends beyond the use as a diagnostic tool, as the 68Ga-isotope can be replaced by a β-emitting isotope, e.g., 177-Lu or 90-Y, enabling radionuclide therapy of FAPI-avid cancers.

Not long after the development of FAPI, the clinical value of FAPI PET/CT in ovarian cancer patients was highlighted by several case reports where FAPI PET/CT detected far more peritoneal metastases than FDG PET/CT. Only recently have cohort studies in ovarian cancer been conducted. In these studies, FAPI PET/CT demonstrates promising results when compared to FDG PET/CT, especially in peritoneal lesions.

Even though the results of FAPI PET/CT compared to conventional imaging seem convincing, there are several limitations and therefore FAPI PET/CT is not yet implemented in cancer diagnostics.

The investigators are conducting a prospective explorative study complying with the Standard for Reporting Diagnostic Accuracy (STARD) criteria where 50 patients with ovarian cancer are recruited.

Study subject will undergo FAPI PET/CT at primary staging (before treatment, i.e., neoadjuvant chemotherapy or surgery) and at restaging (after neoadjuvant chemotherapy - before surgery) in addition to routing diagnostic workup (including FDG PET/CT). The FAPI PET/CT will be blinded and the choice of treatment will not be influence by the FAPI PET/CT results'. The additional scans will not interfere with or delay routine diagnostic workup or treatment. The FAPI PET/CTs (at primary staging and restaging) will be compared to the corresponding FDG PET/CTs, and histopathology of biopsied material and surgical specimens will serve as reference standard. FAPI PET/CTs before and after neoadjuvant chemotherapy will be assessed and compared to the FDG PET/CTs. FAP-immunohistochemistry will be conducted in surgical specimens. A tentative retrospective Multi-Disciplinary Team conference (MDT) will be arranged where treating clinicans are presented the FAPI PET/CT, and potential changes in patient management will be evaluated. This tentative MDT will not influence patient management. Follow up will be conducted for 10 years to evaluate the prognostic value of FAPI PET/CT.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed with biopsy verified ovarian cancer or highly suspected to have ovarian cancer (based on all data presented at the gynecological cancer MDT) and referred to primary staging with FDG PET/CT
* Deemed resectable and operable at the MDT with or without neoadjuvant chemotherapy
* Considered physically and mentally able to participate in the research project
* 18-years or older and able to consent to project participation
* Can read and understand Danish

Exclusion Criteria:

* Patients with non-resectable, inoperable, or recurrent ovarian cancer
* Patients with an imminent need for surgery or in an emergency
* Known concurrent other malignancy within the previous 5 years other than non-melanoma skin cancer
* Patients not suited for surgery or neoadjuvant chemotherapy followed by surgery
* Subject weighing more than 180 kg (weight limit scanner) or unable to fit within the imaging gantry
* History of allergic reactions / hypersensitivity attributed to 18F-FDG or 68Ga-FAPI-46.
* Severe claustrophobia unresponsive to oral anxiolytics
* Subjects with any medical condition or other circumstances that, in the opinion of the Investigator, would significantly decrease the reliability of data, achievement of study objectives or completing the study.
* Pregnant, lactating, or breastfeeding women.
* Potential pregnant women of childbearing potential \[1\] not using effective contraceptives \[2\]. Potential pregnancy will be ascertained by a pregnancy test (urine humane choriogonadotropin (HCG)) or serum b-HCG within 48 hours prior to the FAPI PET/CT.
* Inability to remain still for the duration of the examination

  1. Women of childbearing potential are defined as all women physiologically capable of becoming pregnant, i.e., not sterilized (bilateral tubectomy/occlusion, hysterectomy, bilateral oophorectomy) and not post-menopausal. In cases of uncertain menopausal status, serum follicle stimulating hormone (FSH) levels and menstruation history can be assessed
  2. Effective contraceptives include sexual abstinence, vasectomized partner, combined hormonal contraception (oral, intravaginal, transdermal), progesterone-only contraceptive (oral, injectable, implantable), or working intrauterine device (hormonal, non-hormonal).

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: 2 years
measure: Staging
timeFrame: 2 years
measure: Patient management
timeFrame: 2 - 2.5 years
Secondary outcomes:
measure: Uptake values
timeFrame: 2 years
measure: Chemotherapy effect on uptake values
timeFrame: 2 - 2.5 years
measure: Unexpected 68Ga-FAPI-46 PET/CT findings
timeFrame: 1-2 years
measure: Interobserver readability
timeFrame: 4 years
measure: Prognostic value
timeFrame: 10 years
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: Region Nordjylland
Study officials:
References:
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