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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.

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03349463
Enrollment
30
Registered
2017-11-21
Start date
2018-11-14
Completion date
2020-12-31
Last updated
2020-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, Endometrial Cancer, Ovarian Epithelial Cancer

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.

Interventions

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.

Sponsors

Blue Earth Diagnostics
CollaboratorINDUSTRY
Bital Savir-Baruch
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
18F-Fluciclovine uptake in gynecologic neoplasmsDay 30PET/CT imaging

Countries

United States

Contacts

Primary ContactRachel Ochoa, BA
raochoa@luc.edu708-327-3221

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026