Evaluation of Fluciclovine Uptake in Patients With Cervical, Ovarian Epithelial or Endometrial Cancers.

Cervical Cancer Clinical Trial

Official title:

Evaluation of Fluciclovine Uptake in Patients With Cervical, Ovarian Epithelial or Endometrial Cancers. Pilot Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03349463
• Other study ID #: 209877
• Status: Recruiting
• Phase: Phase 4
• Start date: November 14, 2018
• Est. completion date: December 2020

Study information

• Verified date: February 2020
• Source: Loyola University
• Contact: Rachel Ochoa, BA
• Phone: 708-327-3221
• Email: raochoa[@]luc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Cervical Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Ovarian Epithelial Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Loyola University Medical Center	Maywood	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Bital Savir-Baruch	Blue Earth Diagnostics

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

Cannistra SA. Cancer of the ovary. N Engl J Med. 2004 Dec 9;351(24):2519-29. Review. Erratum in: N Engl J Med. 2005 Jan 6;352(1):104. — View Citation

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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. Review. — View Citation

Kim TH, Kim J, Kang YK, Lee M, Kim HS, Cheon GJ, Chung HH. Identification of Metabolic Biomarkers Using Serial (18)F-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. — View Citation

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. — View Citation

Rockall AG, Cross S, Flanagan S, Moore E, Avril N. The role of FDG-PET/CT in gynaecological cancers. Cancer Imaging. 2012 Mar 5;12:49-65. doi: 10.1102/1470-7330.2012.0007. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	18F-Fluciclovine uptake in gynecologic neoplasms	PET/CT imaging	Day 30