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

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: NCT03036943
Recruitment Status : Completed
First Posted : January 31, 2017
Last Update Posted : December 19, 2018
Sponsor:
Collaborator:
Blue Earth Diagnostics
Information provided by (Responsible Party):
University of Oxford

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Fluciclovine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Open-labelled Study to Characterise Fluciclovine (18F) Uptake Measured by positRon emissiON Tomography In Breast cancER
Actual Study Start Date : February 15, 2017
Actual Primary Completion Date : December 4, 2018
Actual Study Completion Date : December 4, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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:
  • 18F
  • FACBC




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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): NCT03036943


Locations
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United Kingdom
Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Sponsors and Collaborators
University of Oxford
Blue Earth Diagnostics
Investigators
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Principal Investigator: Adrian Harris, Prof University of Oxford

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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03036943     History of Changes
Other Study ID Numbers: OCTO_078
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases