Clinical trial · Interventional
Fluciclovine (18F) Imaging of Breast Cancer
An Open-labelled Study to Characterise Fluciclovine (18F) Uptake Measured by positRon emissiON Tomography In Breast cancER
NCT03036943CI-TRIAL-00036210FRONTIERcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluciclovine | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fluciclovine (18F) PET/CT
- interventionNames
- Radiation: Fluciclovine
Primary outcomes (1)
- measure
- Tumour standardised uptake values (SUV) in invasive breast cancer, classified by molecular type, on fluciclovine (18F) PET imaging.
- timeFrame
- From PET/CT scan commencing approx 30 seconds after fluciclovine (18F) administration
Secondary outcomes (2)
- measure
- 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).
- timeFrame
- From tumour samples taken during standard of care surgery 48 hours or greater after PET/CT scan
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 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 breastfeeding 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 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.
References
Publications (1)
- DERIVEDScott 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 34795409