NCT03036943

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

February 15, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2018

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

1.8 years

First QC Date

December 9, 2016

Last Update Submit

December 18, 2018

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

  • 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

Study Arms (1)

Fluciclovine (18F) PET/CT

EXPERIMENTAL
Radiation: Fluciclovine

Interventions

FluciclovineRADIATION

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

Also known as: 18F, FACBC
Fluciclovine (18F) PET/CT

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • No prior treatment for breast cancer.
  • Female, Age \>= 40 years.
  • 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.
  • Written (signed and dated) informed consent.

You may not qualify if:

  • Pregnant or breastfeeding women
  • Major surgery or significant traumatic injury within four weeks prior to enrolment.
  • Treatment with any other investigational agent, or participation in another interventional clinical study within 4 weeks prior to enrolment.
  • Multifocal breast cancer (defined as more than two tumours, either unilateral or bilateral).
  • Known hypersensitivity to fluciclovine (18F) or any of its constituents.
  • 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.
  • Any other active malignancy or any previous diagnosis of melanoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Churchill Hospital

Oxford, OX3 7LE, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 34795409DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

fluciclovine F-18

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Adrian Harris, Prof

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2016

First Posted

January 31, 2017

Study Start

February 15, 2017

Primary Completion

December 4, 2018

Study Completion

December 4, 2018

Last Updated

December 19, 2018

Record last verified: 2018-12

Locations

GB(1)