Clinical trial · Interventional
A Study to Determine the Value of 18F-FAZA PET Imaging in Patients With Breast Cancer
A Phase II Pre-Treatment Hypoxia PET Imaging Study Using 18F-FAZA in Patients With Invasive Duct Carcinoma of the Breast
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Retirement of former Qualified Investigator and lack of resources to complete study
Summary
Brief summary (as posted)
In about half the cases of breast cancer, there is hypoxic (no, or little oxygen) tissue present. Hypoxic cells can be resistant to treatment and may cause increased tumour growth. This study will use 18F-FAZA PET scans before surgery or treatment to assess whether patients have hypoxic tumours. The results will be compared to tissue samples removed during surgery and to the distribution of 18F-FDG.
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 | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FAZA PET scan | Drug | — | UNRESOLVED |
| FluGlucoScan Injection (18F-FDB) PET scan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- 18F-FAZA + FluGlucoScan Injection
- interventionNames
- Drug: 18F-FAZA PET scan
- Drug: FluGlucoScan Injection (18F-FDB) PET scan
Primary outcomes (1)
- measure
- Uptake of 18F-FAZA (RUS and T/B) and its correlation to tumour size, auxiliary nodal status, tumour grade, EP/PR, and HER-2 status, Ki-67, Androgen receptor status (AR), vimentin and basal keratins, HIF-1 a and glomeruloid microvascular proliferation.
- timeFrame
- 5 years
Secondary outcomes (2)
- measure
- General biodistribution of 18F-FAZA and FluGlucoScan Injection
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female ≥ 18 years of age. If female of child bearing potential and if outside of the window of 10 days since the first day of the 0last menstrual period, patient will be required to have a negative pregnancy test. 2. Pathologically proven invasive duct carcinoma of the breast (FNA or core biopsy), T1-T4(T ≥ 1.5 cm) 3. FluGlucoScan Injection and 18F-FAZA PET scans performed prior to treatment. 4. FluGlucoScan Injection and 18F-FAZA PET scans performed within 4 weeks prior to their definitive surgery if subject does not have neoadjuvant therapy. 5. Able and willing to follow instructions and comply with the protocol 6. Provide written informed consent prior to participation in the study. 7. ECOG performance score ≤ 2 Exclusion Criteria: 1. Previous malignancy or diagnosis less than ten (10) years ago. Skin Cancers (excluding malignant melanoma) and carcinoma in situ of the cervix are exceptions. 2. Excisional biopsy of the primary breast tumour has been performed 3. Women with an invasive carcinoma of the breast that is not predominantly of the invasive duct subtype 4. Primary breast carcinoma previously treated. 5. Women who are nursing or pregnant.
References
Publications (0)
Data not yet available