Breast CancerFRONTIERNCT03036943
Fluciclovine (18F) Imaging of Breast Cancer
A study testing Fluciclovine in people with Breast Cancer, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Fluciclovine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Feb 2017to 4 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-labelled Study to Characterise Fluciclovine (18F) Uptake Measured by positRon emissiON Tomography In Breast cancER
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.
- Conditions
- Breast Cancer
- Being tested
- Fluciclovine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluciclovineRadiation
Also called 18F, FACBC
Fluciclovine (18F) PET/CT scan completed >= 48 hours prior to surgical resection for breast cancer
| Study group | Role | What they receive |
|---|---|---|
| Fluciclovine (18F) PET/CT | Experimental | Not described Receives: Radiation: Fluciclovine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour standardised uptake values (SUV) in invasive breast cancer, classified by molecular type, on fluciclovine (18F) PET imaging.
Measured: 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).
Measured: 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.
Measured: From tumour samples taken during standard of care surgery 48 hours or greater after PET/CT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start15 Feb 2017
- Primary completion4 Dec 2018
- Study completion4 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Responsible party
- Sponsor
- Investigators
- Adrian Harris, Prof, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036943
- Sponsor's protocol ID
- OCTO_078
- Acronym
- FRONTIER
- Status last verified
- Dec 2018
- First submitted
- 9 Dec 2016
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-labelled Study to Characterise Fluciclovine (18F) Uptake Measured by positRon emissiON Tomography In Breast cancER
- ClinicalTrials.gov ID
- NCT03036943
- Acronym / sponsor ID
- FRONTIER / OCTO_078
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 4 Dec 2018 (actual)
- Study completion
- 4 Dec 2018 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluciclovine (18F) PET/CT | Experimental | Radiation: Fluciclovine |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Biopsy proven breast cancer (invasive ductal or ductal carcinoma in situ (DCIS)) measuring ≥ 1.5cm
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluciclovineAlso: 18F, FACBCFluciclovine (18F) PET/CT scan completed >= 48 hours prior to surgical resection for breast cancer | Radiation | Fluciclovine (18F) PET/CT |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Derived from this study: PubMed 34795409Scott 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Harris, Prof principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluciclovine in people with Breast Cancer, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03036943, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.