Clinical trial · Interventional
PET/CT Evaluation of Treatment Response in Breast Cancer
Positron Emission Tomography (PET)-Computed Tomography (CT) PET/CT Evaluation of Treatment Response in Breast Cancer
NCT01222416CI-TRIAL-00028479terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
The purpose of this study is to develop Positron Emission Tomography (PET) - Computed Tomography (CT) PET/CT imaging methods for looking at the effects of chemotherapy in 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 |
|---|---|---|---|
| Radiopharmaceutical: [18F]-FLT | Radiation | — | UNRESOLVED |
| Radiopharmaceutical Administration [18F]-FDG | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- fluorodeoxyglucose PET/CT (FDG-PET/CT)
- description
- A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.
- interventionNames
- Radiation: Radiopharmaceutical Administration [18F]-FDG
- type
- EXPERIMENTAL
- label
- fluorodeoxythymidine PET/CT (FLT-PET/CT)
- description
- A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.
- interventionNames
- Radiation: Radiopharmaceutical: [18F]-FLT
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Subjects must have histologically proven breast cancer * Subjects are being considered for preoperative chemotherapy * Subjects must be ≥ 18 years old. Sensor Sub-Study Only * Palpable subcutaneous or known disease with one surface \<1cm below surface of skin. * A subset of patients who have a mass located on any surface of the breast that is accessible for Lucerno sensor placement will have additional testing. Exclusion Criteria * Children will be excluded from this study. * Pregnant women and women who are breast feeding will be excluded from this study. (The Vanderbilt University Medical Center radiology "PET Procedure Screening Form" will be used to identify and exclude subjects who are pregnant or breastfeeding. A urine pregnancy test/or serum beta HCG will also be performed for women of child bearing potential). * Patients who are acutely ill who are deemed by their treating physician as not suitable candidates for this study. * Intraluminal lesions will be excluded from the sensor sub-study. * Non biopsy proven malignancy will be excluded from this study. * Palpable subcutaneous or known disease with one surface \>1cm below surface of skin will be excluded from the sensor sub-study. * Draining or exposed malignant tumor will be excluded from the sensor sub-study.
References
Publications (0)
Data not yet available
No reference posted for this study.