Recruiting

Fluciclovine

Sponsor:

Bital Savir-Baruch

Code:

NCT03349463

Conditions

Cervical Cancer

Endometrial Cancer

Ovarian Epithelial Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fluciclovine F18

Study Details

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

Study ID

NCT03349463

Start date

Nov 14, 2018

Status verified date

Feb, 2020

Completion date

Dec, 2020

Anticipated

Primary completion date

Dec, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 18F-Fluciclovine

Interventions

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.

Primary outcome measure

  • 18F-Fluciclovine uptake in gynecologic neoplasms [ Time Frame: Day 30 ]

Central Contacts and Locations

Central contacts

Locations

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Principal Investigator:

Bital Savir-Baruch, M.D.

More Information

Sponsor

Bital Savir-Baruch

Last update posted

Feb 28, 2020

Last verified

Feb, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bital Savir-Baruch on 2020-02-28.