Fluciclovine (18F) Imaging of Breast Cancer (FRONTIER)

December 18, 2018 updated by: University of Oxford

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fluciclovine (18F) PET/CT
Radiation: Fluciclovine
Fluciclovine (18F) PET/CT scan completed >= 48 hours prior to surgical resection for breast cancer
Other Names:
  • FACBC
  • 18F

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumour standardised uptake values (SUV) in invasive breast cancer, classified by molecular type, on fluciclovine (18F) PET imaging.
Time Frame: From PET/CT scan commencing approx 30 seconds after fluciclovine (18F) administration
From PET/CT scan commencing approx 30 seconds after fluciclovine (18F) administration

Secondary Outcome Measures

Outcome Measure
Time Frame
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).
Time Frame: From tumour samples taken during standard of care surgery 48 hours or greater after PET/CT scan
From tumour samples taken during standard of care surgery 48 hours or greater after PET/CT scan
Tumour metabolite levels characterized by fold change compared to metabolite levels in the adjacent normal tissue, and correlated to fluciclovine (18F) uptake.
Time Frame: From tumour samples taken during standard of care surgery 48 hours or greater after PET/CT scan
From tumour samples taken during standard of care surgery 48 hours or greater after PET/CT scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

Blue Earth Diagnostics

Investigators

  • Principal Investigator: Adrian Harris, Prof, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 15, 2017

Primary Completion (ACTUAL)

December 4, 2018

Study Completion (ACTUAL)

December 4, 2018

Study Registration Dates

First Submitted

December 9, 2016

First Submitted That Met QC Criteria

January 26, 2017

First Posted (ESTIMATE)

January 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 18, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCTO_078

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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