Fluciclovine (18F) Imaging of Breast Cancer

Breast Cancer Clinical Trial

— FRONTIER  

Official title:

An Open-labelled Study to Characterise Fluciclovine (18F) Uptake Measured by positRon emissiON Tomography In Breast cancER

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03036943
• Other study ID #: OCTO_078
• Status: Completed
• Phase: N/A
• Start date: February 15, 2017
• Est. completion date: December 4, 2018

Study information

• Verified date: December 2018
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to find out what a new amino acid-based PET agent, fluciclovine (18F), can tell us about breast cancer biology (how it grows and develops), and quantify the differences in fluciclovine (18F) uptake between breast cancer subtypes. This will inform further work to investigate its use in breast cancer management.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 4, 2018
• Est. primary completion date: December 4, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Biopsy proven breast cancer (invasive ductal or ductal carcinoma in situ (DCIS)) measuring = 1.5cm

• Tumour size should be based on the longest diameter measured on ultrasound, mammogram or MRI performed within 2 months prior to enrolment.

2. No prior treatment for breast cancer.

3. Female, Age >= 40 years.

4. The patient is willing and able to comply with the protocol scheduled visits and examinations for the duration of the study. Women of childbearing potential must follow contraception guidance given as standard of care at breast cancer diagnosis.

5. Written (signed and dated) informed consent.

Exclusion Criteria:

1. Pregnant or breastfeeding women

2. Major surgery or significant traumatic injury within four weeks prior to enrolment.

3. Treatment with any other investigational agent, or participation in another interventional clinical study within 4 weeks prior to enrolment.

4. Multifocal breast cancer (defined as more than two tumours, either unilateral or bilateral).

5. Known hypersensitivity to fluciclovine (18F) or any of its constituents.

6. Other psychological, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor study candidate or could interfere with protocol compliance or the interpretation of study results.

7. Any other active malignancy or any previous diagnosis of melanoma.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Fluciclovine
Fluciclovine (18F) PET/CT scan completed >= 48 hours prior to surgical resection for breast cancer

Locations

Country	Name	City	State
United Kingdom	Churchill Hospital	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Blue Earth Diagnostics

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumour standardised uptake values (SUV) in invasive breast cancer, classified by molecular type, on fluciclovine (18F) PET imaging.		From PET/CT scan commencing approx 30 seconds after fluciclovine (18F) administration
Secondary	Amino acid transporter (AAT) and related growth pathway expression levels quantitatively assessed by immunohistochemistry using the H-score method, and correlated to fluciclovine (18F) uptake (SUV).		From tumour samples taken during standard of care surgery 48 hours or greater after PET/CT scan
Secondary	Tumour metabolite levels characterized by fold change compared to metabolite levels in the adjacent normal tissue, and correlated to fluciclovine (18F) uptake.		From tumour samples taken during standard of care surgery 48 hours or greater after PET/CT scan