Clinical trial · Interventional
Breast PET Feasibility
Role of Dedicated Breast PET in the Characterisation of Indeterminate Breast Lesions on MRI Requiring a Second-look Ultrasound - a Feasibility Study
- 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)
Breast PET may be able to help in the diagnostic pathway in patients to determine which ones need to go on to have a second look ultrasound +/- biopsy and those who need to be sent for MRI guided biopsy. This may reduce the need to create more anxiety and uncertainty in this group of patients, already extremely stressed by the recent diagnosis of breast cancer.This study involves a single trial visit the Royal Free Hospital for imaging. Participants will need to lie flat for up to 30 minutes on the PET-CT camera and up to 30 minutes on the MAMMI. They will be advised not to take part in this study if they are unable to lie flat on their back and their front for this length of time or if they are claustrophobic. They will be offered the opportunity to see the PET-CT scanner and the MAMMI before deciding to consent to the trial.
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 Neoplasm Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| F-18 FDG breast PET scan | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Breast PET
- description
- PET imaging of breast with patient in prone position.
- interventionNames
- Procedure: F-18 FDG breast PET scan
Primary outcomes (1)
- measure
- Recruitment rate
- timeFrame
- Two years.
- description
- To assess the feasibility and acceptability to patients of F-18 FDG breast PET scans, by determining how many patients can be recruited over two years.
Secondary outcomes (4)
- measure
- Comparison with standard-of-care assessments
- timeFrame
- Two weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female 2. Age over 18 (no upper limit). 3. Not pregnant. 4. Not breastfeeding. 5. Indeterminate breast lesion on MRI requiring a second-look ultrasound. 6. Ability to lie still for up to 30 minutes prone and supine. 7. Females of childbearing potential have a negative pregnancy test within 7 days prior to being registered. Participants are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. 8. Willing and able to provide written informed consent. Exclusion Criteria: 1. Females who are pregnant, planning pregnancy or breastfeeding 2. Concurrent and/or recent involvement in other research that is likely to interfere with the intervention within 3 months prior to study enrolment 3. Inability to lie flat or undergo the tests. 4. Any co-morbidities or conditions which in the opinion of the clinical team means that the patient should be excluded.
References
Publications (0)
Data not yet available