Clinical trial · Interventional
18F-FDG PET/CT Imaging for Breast Cancer
Improving Breast Cancer Staging With 18F-FDG PET/CT Imaging (The IMBRECAS PET 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)
Purpose To investigate the ability of 18F-FDG PET/CT imaging to detect metastases not detected by conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III and locoregional recurrent breast cancer (BC) which can affect the choice of treatment. Hypothesis The hypothesis is that 18F-FDG PET/CT can provide information about disease stage beyond the currently used conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III or locoregional recurrent BC. Objectives Primary: To evaluate if a 18F-FDG PET/CT scan in the initial work up of patients diagnosed with stage II/III or locoregional recurrent BC will lead to change in staging and/or treatment. Secondary: * Overall survival (OS) and progression-free survival (PFS) in the patients with upstaging based on findings on 18F-FDG PET/CT scan compared with the patients with unchanged stage of disease following 18F-FDG PET/CT. * Obtain size of the primary BC from CT/MRI scan and evaluate if these metrics are correlated to outcome. * Obtain PET parameters from the primary BC: maximum, mean, and peak standardized uptake value (SUVmax, SUVmean, SUVpeak), metabolic tumour volume (MTV), total lesion glycolysis (TLG), total MTV and total TLG and evaluate if these metrics are correlated with outcome. * Obtain CT and PET texture parameters from the primary BC and evaluate if these metrics are correlated with outcome. * Blood and tumor samples for molecular characterisation:
Conditions
Conditions (2)
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 Female | — | UNRESOLVED | — |
| Breast Cancer Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FDG PET/CT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Primary breast cancer
- description
- Patients diagnosed with new breast cancer determined to have "high risk" disease by a multidisciplinary team.
- interventionNames
- Other: 18F-FDG PET/CT
- type
- OTHER
- label
- Recurrent breast cancer
- description
- Patients with suspected or proven locoregional recurrent breast cancer.
- interventionNames
- Other: 18F-FDG PET/CT
Primary outcomes (1)
- measure
- Change in staging and/or management due to added 18F-FDG PET/CT scan
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with high risk primary or recurrent breast cancer * Non pregnant women \> 18 years * Not receiving active treatment of other cancer types. * Eastern Cooperative Oncology Group (ECOG) status 0-2. Exclusion Criteria: * Pregnant woman * Males * Age under 18 * Patients receiving active treatment for other cancers * Poor general conditipon (ECOG 3 or higher)
References
Publications (0)
Data not yet available