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Full Title

An open-labelled study to characterise Fluciclovine (18F) uptake measured by positron emission tomography in breast cancer

FRONTIER.pngChief Investigator: Adrian Harris

Study Design

This pre-operative observational imaging study will characterise the uptake of Fluciclovine 18F-FACBC on PET imaging in different breast cancer subtypes and correlate uptake with gene expression and metabolomic profile to form the basis of further work to investigate its potential uses. The study group will include up to 45 participants recruited from the Churchill Hospital in Oxford. Participants will be post-menopausal women with histologically proven breast cancer measuring ≥ 2cm scheduled to be treated by primary surgical resection. All participants will undergo fluciclovine (18F) PET/CT of the breast tumour before surgery, and breast tumour sample collection during surgery. Fluciclovine (18F) uptake by the tumour will then be compared to the tumour receptor subtype and results of the tumour sample analyses.

Study Status

Recruitment Status: Closed

Target Recruitment: Up to 45 in total

Final Recruitment:44 in total

Site: Churchill Hospital, Oxford University Hospital Trust

Inclusion Criteria

  1. Biopsy proven breast cancer (invasive ductal or ductal carcinoma in situ (DCIS) measuring ≥ 1.5cm.
    1. 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 breast‐feeding 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 four 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 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.

Primary Objective

Tumour standardised uptake values (SUV) in invasive breast cancer, classified by molecular type, on Fluciclovine (18F) PET imaging.

Secondary Objectives

  • AAT and mTOR expression quantified by immunohistochemical analysis, correlated with tumour SUVs.
  • Tumour metabolite levels from metabolomics analysis, correlated with tumour SUVs.

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