Clinical trial · Interventional
Piloting 18F-FAPI PET/MRI for Applications in Breast Cancer
- 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 cancer is the most common type of cancer in Norwegian women, with 4,224 new cases in 2022. More precise diagnosis are expected to result in more accurate assessment of treatment effect, and to contribute to both providing better treatment and reducing overtreatment. Fibroblast activating protein (FAP) is expressed in the tumor stroma of 90% of all epithelial-based tumors, including breast tumors. Inhibitors for this protein (FAPI) has been developed for use as radioactive tracers. Breast tumors of various histopathological types, and local metastatic lymph nodes, have shown high uptake for such tracers. The main aim of this project is to establish 18F-FAPI PET/MRI for use in breast cancer in a wide range of disease stages. We will evaluate how FAPI PET/MRI correlates with histopathological assessment, the method's ability to grade tumors - including assessment of treatment - compared to CT, scintigraphy and FDG PET/CT, and ability to detect local recurrence.
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 |
|---|---|---|---|
| FAPI PET/MR | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FAPI-PET/MRI
- description
- The patients will be injected 2 MBq/kg 18F-FAPI, prior to PET/MRI acquisition
- interventionNames
- Diagnostic Test: FAPI PET/MR
Primary outcomes (1)
- measure
- Diagnostic accuracy of 18F-FAPI-PET/MRI in detection of breast cancer lesions
- timeFrame
- Baseline
- description
- Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of 18F-FAPI-PET/MRI in detecting breast cancer lesions, including primary tumors, regional lymph node metastases, distant metastases, and local/distant recurrences. Interpretation will be based on consensus assessment by nuclear medicine physicians and radiologists. Histopathology and/or conventional imaging (CT, FDG-PET, bone scintigraphy) will serve as the reference standards.
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Inclusion criteria are accepting to undergo 18F-FAPI PET/MRI examinations and 1. diagnosed with local invasive breast cancer, 2. scheduled for neoadjuvant therapy as primary treatment, 3. has recurrent or new breast cancer, or 4. scheduled for neoadjuvant therapy as primary treatment with FDG-PET/CT applied for staging. Exclusion Criteria: * other primary malignancies than breast cancer, renal insufficiency or know allergy towards contrast agents, and MR incompatible implants.
References
Publications (0)
Data not yet available