Clinical trial NCT03349463: Evaluation of Fluciclovine Uptake in Patients With Cervical, Ovarian Epithelial or Endometrial Cancers.
Official title: Evaluation of Fluciclovine Uptake in Patients With Cervical, Ovarian Epithelial or Endometrial Cancers. Pilot Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cervical Cancer
Endometrial Cancer
Ovarian Epithelial Cancer
Lead sponsor: Loyola University
Sponsor class: OTHER
Collaborators: name: Blue Earth Diagnostics
First posted: 2017-11-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: 18F-Fluciclovine uptake in gynecologic neoplasms
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
affiliation: Nuclear Medicine Assistant Professor
name: Bital Savir-Baruch, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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