Evaluation of Fluciclovine Uptake in Patients With Cervical, Ovarian Epithelial or Endometrial Cancers.
NCT ID: NCT03349463
Last Updated: 2020-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2018-11-14
2020-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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18F-Fluciclovine
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Systemic therapy for cancer in the past 3 months
* Inability to tolerate 18F-fluciclovine PET/CT exam
* Pregnant or lactating women
18 Years
FEMALE
No
Sponsors
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Blue Earth Diagnostics
INDUSTRY
Bital Savir-Baruch
OTHER
Responsible Party
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Bital Savir-Baruch
Nuclear Medicine Assistant Professor
Principal Investigators
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Bital Savir-Baruch, M.D
Role: PRINCIPAL_INVESTIGATOR
Nuclear Medicine Assistant Professor
Locations
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Loyola University Medical Center
Maywood, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Atri M, Zhang Z, Dehdashti F, Lee SI, Ali S, Marques H, Koh WJ, Moore K, Landrum L, Kim JW, DiSilvestro P, Eisenhauer E, Schnell F, Gold M. Utility of PET-CT to evaluate retroperitoneal lymph node metastasis in advanced cervical cancer: Results of ACRIN6671/GOG0233 trial. Gynecol Oncol. 2016 Sep;142(3):413-9. doi: 10.1016/j.ygyno.2016.05.002. Epub 2016 Jul 27.
Cannistra SA. Cancer of the ovary. N Engl J Med. 2004 Dec 9;351(24):2519-29. doi: 10.1056/NEJMra041842. No abstract available.
Khiewvan B, Torigian DA, Emamzadehfard S, Paydary K, Salavati A, Houshmand S, Shamchi SP, Werner TJ, Aydin A, Roy SG, Alavi A, Kumar R. Update of the role of PET/CT and PET/MRI in the management of patients with cervical cancer. Hell J Nucl Med. 2016 Sep-Dec;19(3):254-268. doi: 10.1967/s002449910409. Epub 2016 Nov 8.
Kim TH, Kim J, Kang YK, Lee M, Kim HS, Cheon GJ, Chung HH. Identification of Metabolic Biomarkers Using Serial 18F-FDG PET/CT for Prediction of Recurrence in Advanced Epithelial Ovarian Cancer. Transl Oncol. 2017 Jun;10(3):297-303. doi: 10.1016/j.tranon.2017.02.001. Epub 2017 Mar 15.
Kizer NT, Zighelboim I, Case AS, Dewdney SB, Thaker PH, Massad LS. The role of PET/CT in the management of patients with cervical cancer: practice patterns of the members of the Society of Gynecologic Oncologists. Gynecol Oncol. 2009 Aug;114(2):310-4. doi: 10.1016/j.ygyno.2009.04.018. Epub 2009 May 14.
Rockall AG, Cross S, Flanagan S, Moore E, Avril N. The role of FDG-PET/CT in gynaecological cancers. Cancer Imaging. 2012 Mar 5;12(1):49-65. doi: 10.1102/1470-7330.2012.0007.
Signorelli M, Guerra L, Buda A, Picchio M, Mangili G, Dell'Anna T, Sironi S, Messa C. Role of the integrated FDG PET/CT in the surgical management of patients with high risk clinical early stage endometrial cancer: detection of pelvic nodal metastases. Gynecol Oncol. 2009 Nov;115(2):231-5. doi: 10.1016/j.ygyno.2009.07.020. Epub 2009 Aug 19.
Jager PL, Vaalburg W, Pruim J, de Vries EG, Langen KJ, Piers DA. Radiolabeled amino acids: basic aspects and clinical applications in oncology. J Nucl Med. 2001 Mar;42(3):432-45.
Washburn LC, Sun TT, Anon JB, Hayes RL. Effect of structure on tumor specificity of alicyclic alpha-amino acids. Cancer Res. 1978 Aug;38(8):2271-3.
Washburn LC, Sun TT, Byrd B, Hayes RL, Butler TA. 1-aminocyclobutane[11C]carboxylic acid, a potential tumor-seeking agent. J Nucl Med. 1979 Oct;20(10):1055-61.
Savir-Baruch B, Lovrec P, Solanki AA, Adams WH, Yonover PM, Gupta G, Schuster DM. Fluorine-18-Labeled Fluciclovine PET/CT in Clinical Practice: Factors Affecting the Rate of Detection of Recurrent Prostate Cancer. AJR Am J Roentgenol. 2019 Oct;213(4):851-858. doi: 10.2214/AJR.19.21153. Epub 2019 Jun 19.
Other Identifiers
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209877
Identifier Type: -
Identifier Source: org_study_id
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