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

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ClinicalTrials.gov Identifier: NCT03349463
Recruitment Status : Recruiting
First Posted : November 21, 2017
Last Update Posted : March 21, 2019
Sponsor:
Collaborator:
Blue Earth Diagnostics
Information provided by (Responsible Party):
Bital Savir-Baruch, Loyola University

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.


Condition or disease Intervention/treatment Phase
Cervical Cancer Endometrial Cancer Ovarian Epithelial Cancer Drug: Fluciclovine F18 Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Fluciclovine Uptake in Patients With Cervical, Ovarian Epithelial or Endometrial Cancers. Pilot Study.
Actual Study Start Date : November 14, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


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




Primary Outcome Measures :
  1. 18F-Fluciclovine uptake in gynecologic neoplasms [ Time Frame: Day 30 ]
    PET/CT imaging



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349463


Contacts
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Contact: Rachel Ochoa, BA 708-327-3221 raochoa@luc.edu

Locations
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United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Bital Savir-Baruch, M.D    708-216-2508    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         
Sponsors and Collaborators
Bital Savir-Baruch
Blue Earth Diagnostics
Investigators
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Principal Investigator: Bital Savir-Baruch, M.D Nuclear Medicine Assistant Professor

Publications:

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Responsible Party: Bital Savir-Baruch, Nuclear Medicine Assistant Professor, Loyola University
ClinicalTrials.gov Identifier: NCT03349463     History of Changes
Other Study ID Numbers: 209877
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Carcinoma, Ovarian Epithelial
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Ovarian Neoplasms
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders