Evaluation of Fluciclovine Uptake in Patients With Cervical, Ovarian Epithelial or Endometrial Cancers.

Evaluation of Fluciclovine Uptake in Patients With Cervical, Ovarian Epithelial or Endometrial Cancers. Pilot Study.

An important part of staging and deciding the method of treatment is knowing areas of how cancer is involved. Diagnostic imaging is often used to determine the location of the cancer using techniques like nuclear medicine, MRI (magnetic resonance imaging), CT (computerized tomography), and ultrasound. Each technique looks for cancer in different ways and are often used together to make a better determination of the extent of disease.

One of the techniques used in cancer imaging is PET/CT. This technique combines a nuclear medicine study (PET or positron emission tomography) with CT performing both scans at the same time. PET/CT most commonly uses a radioactive sugar (FDG or fluorodeoxyglucose) to detect the cancer. The problem with FDG is that it is excreted by the kidneys and collected in the bladder. Even though the bladder is emptied prior to the scan, the FDG activity present there may interfere with the detection of small areas of cancer involvement in lymph nodes or adjacent areas. It is because of this that PET/CT using FDG is infrequently used in gynecological cancers.

This purpose of this study is to evaluate if 18F-fluciclovine can be used to help determine the extent of gynecological cancers. 18F-fluciclovine (also known as AXUMIN) is a radioactive tracer which has been approved by the FDAFood and Drug Administration (FDA) for use in patients with prostate cancer. 18F-fluciclovine has much less excretion through the kidneys which improves the PET/CT imaging of the pelvis.

Study Overview

• Status: Unknown
• Conditions: Cervical Cancer; Ovarian Epithelial Cancer; Endometrial Cancer
• Intervention / Treatment: Drug: Fluciclovine F18

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Rachel Ochoa, BA; Phone Number: 708-327-3221; Email: raochoa@luc.edu

Study Locations

• United States
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Recruiting
      • Loyola University Medical Center
      • Contact: Bital Savir-Baruch, M.D; Phone Number: 708-216-2508; Email: bital.savir-baruch@lumc.edu
      • Principal Investigator: Bital Savir-Baruch, M.D.
      • Sub-Investigator: Robert H Wagner, M.D.
      • Sub-Investigator: Ronald K Potkul, M.D.
      • Sub-Investigator: Abigail Winder, M.D.
      • Sub-Investigator: Margaret Liotta, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• GYN cancer (ovarian, endometrial, or cervical) was biopsy-proven and/or schedule for subsequent surgery based on clinical presentation (imaging, markers)
• Age ≥ 18 years.
• Can tolerate 18F-fluciclovine PET/CT exam (can lie on her back for the duration of the scan).
• Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

• Ongoing systemic therapy for cancer
• Systemic therapy for cancer in the past 3 months
• Inability to tolerate 18F-fluciclovine PET/CT exam
• Pregnant or lactating women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 18F-Fluciclovine	Drug: Fluciclovine F18; All study participants will receive 10 mCi of 18F-Fluciclovine (Axumin) one time administered through injection through the catheter into participant's arm immediately before PET/CT scan.; Other Names: Axumin; anti-3-[18F] FACBC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
18F-Fluciclovine uptake in gynecologic neoplasms	PET/CT imaging	Day 30

Collaborators and Investigators

• Sponsor: Bital Savir-Baruch
• Collaborators: Blue Earth Diagnostics
• Investigators: Principal Investigator: Bital Savir-Baruch, M.D, Nuclear Medicine Assistant Professor

Publications and helpful links

General Publications

• Atri M, Zhang Z, Dehdashti F, Lee SI, Ali S, Marques H, Koh WJ, Moore K, Landrum L, Kim JW, DiSilvestro P, Eisenhauer E, Schnell F, Gold M. Utility of PET-CT to evaluate retroperitoneal lymph node metastasis in advanced cervical cancer: Results of ACRIN6671/GOG0233 trial. Gynecol Oncol. 2016 Sep;142(3):413-9. doi: 10.1016/j.ygyno.2016.05.002. Epub 2016 Jul 27.
• Cannistra SA. Cancer of the ovary. N Engl J Med. 2004 Dec 9;351(24):2519-29. doi: 10.1056/NEJMra041842. No abstract available. Erratum In: N Engl J Med. 2005 Jan 6;352(1):104.
• Khiewvan B, Torigian DA, Emamzadehfard S, Paydary K, Salavati A, Houshmand S, Shamchi SP, Werner TJ, Aydin A, Roy SG, Alavi A, Kumar R. Update of the role of PET/CT and PET/MRI in the management of patients with cervical cancer. Hell J Nucl Med. 2016 Sep-Dec;19(3):254-268. doi: 10.1967/s002449910409. Epub 2016 Nov 8.
• Kim TH, Kim J, Kang YK, Lee M, Kim HS, Cheon GJ, Chung HH. Identification of Metabolic Biomarkers Using Serial 18F-FDG PET/CT for Prediction of Recurrence in Advanced Epithelial Ovarian Cancer. Transl Oncol. 2017 Jun;10(3):297-303. doi: 10.1016/j.tranon.2017.02.001. Epub 2017 Mar 15.
• Kizer NT, Zighelboim I, Case AS, Dewdney SB, Thaker PH, Massad LS. The role of PET/CT in the management of patients with cervical cancer: practice patterns of the members of the Society of Gynecologic Oncologists. Gynecol Oncol. 2009 Aug;114(2):310-4. doi: 10.1016/j.ygyno.2009.04.018. Epub 2009 May 14.
• Rockall AG, Cross S, Flanagan S, Moore E, Avril N. The role of FDG-PET/CT in gynaecological cancers. Cancer Imaging. 2012 Mar 5;12(1):49-65. doi: 10.1102/1470-7330.2012.0007.
• Signorelli M, Guerra L, Buda A, Picchio M, Mangili G, Dell'Anna T, Sironi S, Messa C. Role of the integrated FDG PET/CT in the surgical management of patients with high risk clinical early stage endometrial cancer: detection of pelvic nodal metastases. Gynecol Oncol. 2009 Nov;115(2):231-5. doi: 10.1016/j.ygyno.2009.07.020. Epub 2009 Aug 19.
• Jager PL, Vaalburg W, Pruim J, de Vries EG, Langen KJ, Piers DA. Radiolabeled amino acids: basic aspects and clinical applications in oncology. J Nucl Med. 2001 Mar;42(3):432-45.
• Washburn LC, Sun TT, Anon JB, Hayes RL. Effect of structure on tumor specificity of alicyclic alpha-amino acids. Cancer Res. 1978 Aug;38(8):2271-3.
• Washburn LC, Sun TT, Byrd B, Hayes RL, Butler TA. 1-aminocyclobutane[11C]carboxylic acid, a potential tumor-seeking agent. J Nucl Med. 1979 Oct;20(10):1055-61.
• Savir-Baruch B, Lovrec P, Solanki AA, Adams WH, Yonover PM, Gupta G, Schuster DM. Fluorine-18-Labeled Fluciclovine PET/CT in Clinical Practice: Factors Affecting the Rate of Detection of Recurrent Prostate Cancer. AJR Am J Roentgenol. 2019 Oct;213(4):851-858. doi: 10.2214/AJR.19.21153. Epub 2019 Jun 19.

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2018
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: November 17, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (Actual): November 21, 2017

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 27, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: 209877

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No