Clinical trial · Observational
Study on the Value of Non-invasive Dual-Pet Information in Subtype of Metastatic Breast Cancer
A Phase II, Single-center STudy on the vAlue of Non-invasive Dual-Pet（18F-FES PET and 68Ga-HER2-Affibody PET）InformatiOn IN Subtype of Metastatic Breast Cancer(MBC)
NCT04758416CI-TRIAL-00057928unknownClinicalTrials.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)
Study on the Value of Non-invasive Dual-Pet(18F-FES PET and 68Ga-HER2-Affibody PET) Information in Subtype of Metastatic Breast Cancer
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-HER2 affibody,18F-FDG, 18F-FES | Drug | — | UNRESOLVED |
| biopsy or surgical pathology in metastases | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Metastatic breast cancer patients
- description
- 50 metastatic breast cancer patients
- interventionNames
- Procedure: biopsy or surgical pathology in metastases
- Drug: 68Ga-HER2 affibody,18F-FDG, 18F-FES
Primary outcomes (1)
- measure
- Verify the subtype value of dual-PET in extrahepatic metastases
- timeFrame
- 2 year
- description
- Verify whether the subtype value of FES-PET and HER2-PET is consistent with biopsy or surgical pathology in extrahepatic metastases.
Secondary outcomes (3)
- measure
- Verify the HER2-PET value in liver metastasis
- timeFrame
- 2 year
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects voluntarily joined the study, signed informed consent, and had good compliance. 2. Female patients aged over 18 years (including cutoff value). 3. an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 4. Recurrence or metastatic breast cancer confirmed by histopathology, or expect to be feasible metastasis puncture or surgery to confirm histopathological recurrence or metastatic breast cancer. Exclusion Criteria: 1. Pregnancy or lactation. 2. Alcohol allergy is not suitable for FES-PET/ C. 3. There are contraindications for patients who are expected to have metastasis puncture or surgery. 4. Mental disorders or other conditions affecting patient compliance.
References
Publications (0)
Data not yet available
No reference posted for this study.