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CompletedNCT03036943FRONTIERUpdated Dec 19, 2018

Fluciclovine (18F) Imaging of Breast Cancer

An interventional study of Fluciclovine in Breast Cancer, sponsored by University of Oxford. Completed at 1 site in United Kingdom. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2018-12-19.

Sponsored by University of Oxford · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
40 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Breast Cancer

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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 40 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Fluciclovine (18F) PET/CT

    Radiation: Fluciclovine

Interventions

  • RadiationFluciclovine

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

    Also known as: 18F, FACBC

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What researchers measure

Primary outcomes

  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 outcomes

  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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Study locations

1 site
  • Churchill Hospital
    Oxford, OX3 7LE, United Kingdom
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References and documents

Publications

  • Scott NP, Teoh EJ, Flight H, Jones BE, Niederer J, Mustata L, MacLean GM, Roy PG, Remoundos DD, Snell C, Liu C, Gleeson FV, Harris AL, Lord SR, McGowan DR. Characterising 18F-fluciclovine uptake in breast cancer through the use of dynamic PET/CT imaging. Br J Cancer. 2022 Mar;126(4):598-605. doi: 10.1038/s41416-021-01623-3. Epub 2021 Nov 18. PubMed 34795409 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03036943
Lead sponsor
University of Oxford
Collaborators
Blue Earth Diagnostics
Responsible party
Sponsor
First posted
Jan 31, 2017
Start date
Feb 15, 2017
Primary completion
Dec 4, 2018
Completion
Dec 4, 2018
Last update
Dec 19, 2018

Study contacts

Adrian Harris, Prof
principal investigator · University of Oxford

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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