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

Primary Purpose

Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Fluciclovine

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Churchill Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fluciclovine (18F) PET/CT

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

Tumour metabolite levels characterized by fold change compared to metabolite levels in the adjacent normal tissue, and correlated to fluciclovine (18F) uptake.

Full Information

NCT ID

NCT03036943

First Posted

December 9, 2016

Last Updated

December 18, 2018

Sponsor

University of Oxford

Collaborators

Blue Earth Diagnostics

1. Study Identification

Unique Protocol Identification Number

NCT03036943

Brief Title

Fluciclovine (18F) Imaging of Breast Cancer

Acronym

FRONTIER

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

February 15, 2017 (Actual)

Primary Completion Date

December 4, 2018 (Actual)

Study Completion Date

December 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Oxford

Collaborators

Blue Earth Diagnostics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fluciclovine (18F) PET/CT

Arm Type

Experimental

Intervention Type

Radiation

Intervention Name(s)

Fluciclovine

Other Intervention Name(s)

18F, FACBC

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adrian Harris, Prof

Organizational Affiliation

University of Oxford

Official's Role

Principal Investigator

Facility Information:

Facility Name

Churchill Hospital

City

Oxford

ZIP/Postal Code

OX3 7LE

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

34795409

Citation

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.

Results Reference

derived

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Fluciclovine (18F) Imaging of Breast Cancer

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