Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2017-02-15
2018-12-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Fluciclovine (18F) PET/CT
Fluciclovine
Fluciclovine (18F) PET/CT scan completed \>= 48 hours prior to surgical resection for breast cancer
Interventions
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Fluciclovine
Fluciclovine (18F) PET/CT scan completed \>= 48 hours prior to surgical resection for breast cancer
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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.
40 Years
FEMALE
No
Sponsors
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Blue Earth Diagnostics
INDUSTRY
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Adrian Harris, Prof
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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Churchill Hospital
Oxford, , United Kingdom
Countries
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References
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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.
Other Identifiers
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OCTO_078
Identifier Type: -
Identifier Source: org_study_id