Clinical trial · Interventional
PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer
Development of an In Vivo Cell Proliferation Marker for PET Assessment of Chemotherapeutic Response in Cancer
NCT01712815CI-TRIAL-00068736terminatedN/AClinicalTrials.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): Insufficient accrual
Summary
Brief summary (as posted)
This phase I trial studies the side effects of positron emission tomography (PET)/computed tomography (CT) in evaluating response to chemotherapy in patients with breast cancer. Comparing results of diagnostic procedures done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Breast Cancer | Malignant Breast Neoplasm |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorine F 18-clevudine | Radiation | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| positron emission tomography/computed tomography | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (fluorine F 18-clevudine PET/CT)
- description
- Patients receive fluorine F18-clevudine IV over 1 minute and then undergo PET/CT scan at baseline. Patients with HER2+ breast cancer also undergo fluorine F 18-clevudine PET/CT scan 2-3 weeks after the first course of treatment and after completion of treatment.
- interventionNames
- Other: laboratory biomarker analysis
- Other: pharmacological study
- Other: questionnaire administration
- Radiation: fluorine F 18-clevudine
- Procedure: positron emission tomography/computed tomography
Primary outcomes (2)
- measure
- Change of FMAU-PET score vs. change of Ki-67 from the baseline to post-chemotherapy
- timeFrame
- Up to 1 year
- measure
- Incidence of adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Inclusion criteria for Aim 1: * Scheduled to receive therapy with trastuzumab plus chemotherapy as part of standard care * Have one or more breast tumors visualized by conventional PET/CT, CT or magnetic resonance imaging (MRI) prior to the PET FMAU study; PET/CT should be within a week prior to 18-F FMAU Inclusion criteria for Aim 2: * Have been diagnosed with a HER2+ invasive cancer of the breast * Scheduled to receive pre-operative therapy with trastuzumab plus chemotherapy as part of standard care * Have one or more breast tumors visualized by conventional PET/CT, CT or MRI prior to the PET FMAU study; PET/CT should be within a week prior to 18-F FMAU Exclusion Criteria: * Have undergone chemotherapy or radiation therapy within the previous one month * Women of childbearing potential, unless they have had a negative urine human chorionic gonadotropin (HCG) within the previous 24 hours of the procedure * Patients who have had surgery at the site of the suspected lesion within 1 month
References
Publications (0)
Data not yet available
No reference posted for this study.