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

NCT03349463 | Unknown Phase 4 FDA Drug

• 1 other identifier: 209877
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Cancer; Endometrial Cancer; Ovarian Epithelial Cancer

Outcome Measures

Primary Outcomes (1)

• 18F-Fluciclovine uptake in gynecologic neoplasms

  PET/CT imaging

  Day 30

Study Arms (1)

18F-Fluciclovine

EXPERIMENTAL

Drug: Fluciclovine F18

Interventions

Fluciclovine F18 DRUG

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.

Also known as: Axumin, anti-3-[18F] FACBC

18F-Fluciclovine

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bital Savir-Baruch: lead
• Blue Earth Diagnostics: collaborator

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

RECRUITING

Related Publications (11)

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  PMID: 27178725 BACKGROUND

• Cannistra SA. Cancer of the ovary. N Engl J Med. 2004 Dec 9;351(24):2519-29. doi: 10.1056/NEJMra041842. No abstract available.

  PMID: 15590954 BACKGROUND

• 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.

  PMID: 27824966 BACKGROUND

• 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.

  PMID: 28314183 BACKGROUND

• 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.

  PMID: 19446317 BACKGROUND

• 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.

  PMID: 22391444 BACKGROUND

• 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.

  PMID: 19695685 BACKGROUND

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  PMID: 208763 BACKGROUND

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  PMID: 231642 BACKGROUND

• 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.

  PMID: 31216198 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

fluciclovine F-18

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Ovarian Neoplasms; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Bital Savir-Baruch, M.D

  Nuclear Medicine Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Ochoa, BA

CONTACT

708-327-3221; raochoa@luc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nuclear Medicine Assistant Professor

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 21, 2017
• Study Start: November 14, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)