Evaluation of Fluciclovine Uptake in Patients With Cervical, Ovarian Epithelial or Endometrial Cancers.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03349463|
Recruitment Status : Unknown
Verified February 2020 by Bital Savir-Baruch, Loyola University.
Recruitment status was: Recruiting
First Posted : November 21, 2017
Last Update Posted : February 28, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 2020|
|Estimated Study Completion Date :||December 2020|
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.
- 18F-Fluciclovine uptake in gynecologic neoplasms [ Time Frame: Day 30 ]PET/CT imaging
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
|Contact: Rachel Ochoa, BAemail@example.com|
|United States, Illinois|
|Loyola University Medical Center||Recruiting|
|Maywood, Illinois, United States, 60153|
|Contact: Bital Savir-Baruch, M.D 708-216-2508 firstname.lastname@example.org|
|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|
|Principal Investigator:||Bital Savir-Baruch, M.D||Nuclear Medicine Assistant Professor|