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

NCT03811899 | Completed

• 1 other identifier: 18-6241
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stage III Ovarian Cancer; Stage IV Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 18F-DCFPyL-avid PET/CT

  To determine the proportion of HG EOC that are18F-DCFPyL-avid on PET/CT.

  Through study completion up to 2 years

Secondary Outcomes (1)

• 18F-DCFPyL PET/CT vs. Contrast-enhanced CT

  Through study completion up to 2 years

Study Arms (1)

18F-DCFPyL PET/CT imaging

EXPERIMENTAL

We will use 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 is gathered at one time, will be performed on an integrated PET-CT scanner located at Princess Margaret Cancer Centre.

Diagnostic Test: 18F-DCFPyL

Interventions

18F-DCFPyL DIAGNOSTIC_TEST

The purpose of this study is to determine whether HG SOC are 18F-DCFPyL (=GCP-II)-avid and to compare the performance of this PET to CT and findings at time of surgery.

18F-DCFPyL PET/CT imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (2)

• Kunikowska 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 DERIVED

• Metser 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 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Ur Metser, MD

  UHN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm study to determine whether HG EOC are 18F-DCFPyL-avid.

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 22, 2019
• Study Start: April 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: October 13, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-11

Locations

CA (1)