18F-DCFPyL PET/CT in High-grade Epithelial Ovarian Cancer (PET HOC)

The purpose of this study is to determine whether high grade epithelial ovarian cancers (=HG EOC) are 18F-DCFPyL (=2-(3-(1-carboxy-5-\[(6-\[18F\]fluoro-pyridine-3-carbonyl)-amino\]-pentyl)-ureido)-pentanedioic acid)-avid and to compare the performance of this PET to CT and findings at time of surgery Background: There is a need for better noninvasive tools that will map disease extent in HG EOC. A recent study has shown that at immunohistochemistry GCP=II is overexpressed in ovarian cancer tumors, both primary and metastatic. Glucose carboxypeptidase-II (=GCP-II), also known as prostate specific membrane antigen (= PSMA) has been used clinically to assess patients with prostate cancer and many other tumors have been shown to be PSMA-avid on PET (including renal cell carcinomas). 18F-DCFPyL has the potential to improve patient selection for primary therapy. If successful, this may decrease the rate of futile surgeries and associated morbidity and better direct patients to the most appropriate therapy primary debulking surgery (PDS) vs neoadjuvant chemotherapy (NACT). Furthermore, if high-level GCP-II expression is shown at preoperative imaging in patients with HG EOC, this may be used in considering feasibility of future theranostic applications. Study Design: This is a single arm pilot study to assess whether HG EOC are 18F-DCFPyL-avid. In this prospective trial, the investigators will recruit 20 women whom will undergo conventional staging with contrast-enhanced CT of the abdomen and pelvis as per standard of care. All disease sites, primary and metastatic will be recorded using a standardized reporting template. Subsequently, 18F-DCFPyL-PET/CT will be performed (within 6 weeks of CT). All disease sites on PET will be recorded using same reporting template in addition to qualitative and semiquantitative evaluation (SUV measurement) of all known tumor sites.

Sex

Female

Minimum age

18 Years

Inclusion Criteria:

* Age ≥18 years
* Cytological or histological diagnosis of high grade epithelial ovarian cancer, or clinical suspicious of HG EOC based on symptoms, physical exam, tumor markers and imaging findings.
* Clinical stage III or IV, being considered for primary debulking surgery or NACT.
* Contrast-enhanced CT abdomen and pelvis within 6 weeks of PET (prior to enrollment).

Exclusion Criteria:

* Inability to provide informed consent.
* Contraindication 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 tumors.

• DERIVEDKunikowska J, Bizon M, Pelka K, Derlatka P, Olszewski M, Krolicki L. 68 Ga-Prostate-Specific Membrane Antigen PET/CT in Ovarian Tumors : Potential to Differentiate Benign and Malignant Tumors Before Surgery: A Preliminary Report. Clin Nucl Med. 2023 Feb 1;48(2):e60-e66. doi: 10.1097/RLU.0000000000004486. Epub 2022 Nov 18. PMID 36512649
• DERIVEDMetser U, Kulanthaivelu R, Chawla T, Johnson S, Avery L, Hussey D, Veit-Haibach P, Bernardini M, Hogen L. 18F-DCFPyL PET/CT in advanced high-grade epithelial ovarian cancer: A prospective pilot study. Front Oncol. 2022 Oct 13;12:1025475. doi: 10.3389/fonc.2022.1025475. eCollection 2022. PMID 36313720