| December 11, 2007 |
| March 6, 2009 |
| February 2009 |
| November 2009 (final data collection date for primary outcome measure) |
| 18F]FLT uptake of the primary tumor in patients with locally advanced breast cancer [ Time Frame: 2 years ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00572728 on ClinicalTrials.gov Archive Site |
| Vital signs, clinical laboratory tests, ECG [ Time Frame: 2 years ] [ Designated as safety issue: Yes ] |
| Same as current |
| |
| Safety and Efficacy Study of FLT Radiolabeled Imaging Agent With PET Scan in Invasive Breast Cancer |
| A Phase II Study of 3'-Deoxy-3'-18F Fluorothymidine (FLT) in Invasive Breast |
This trial will test the effectiveness of a new imaging agent, [F-18] FLT, in predicting the success of chemotherapy treatment. Imaging agents are drugs that are given before or during an imaging procedure to improve the quality of the images (like medical x-rays) that are obtained. When [F-18] FLT is used during positron emission tomography (PET) imaging, it may produce images that will tell in advance whether the tumor will respond to the treatment. |
| |
| Phase II |
| Interventional |
| Screening, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Breast Cancer |
| Drug: 3'-Deoxy-3'-18F Fluorothymidine |
| Experimental: 3'-Deoxy-3'-18F Fluorothymidine |
| |
| |
| Recruiting |
| 36 |
| November 2009 |
| November 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Pathologically confirmed breast cancer, determined to be a candidate for primary systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor following completion of neoadjuvant therapy
- Tumor size >2cm, measured on imaging or estimated by physical exam
- No obvious contraindications for primary chemotherapy with docetaxel, adriamycin, or cyclophosphamide
- Residual tumor planned to be removed surgically following completion of neoadjuvant therapy
- Able to lie still for 1.5 hours
- Age 18 years or older.
- leukocytes ≥ 3,000/μl
- absolute neutrophil count ≥ 1,500/μl
- platelets ≥ 100,000/μl
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) ≤ 2.5 times the institutional upper limit of normal
- creatinine within normal institutional limits OR, for patients with creatinine levels above institutional normal, or clearance ≥ 60 mL/min/1.73 m2
- If female, postmenopausal for a minimum of one year, or surgically sterile, or not pregnant, confirmed by ß-HCG blood test
Exclusion Criteria:
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Medically unstable
- Condition requiring anesthesia for PET scanning
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to F-18 fluorothymidine
|
| Both |
| 18 Years and older |
| No |
|
|
| United States |
| |
| NCT00572728 |
| Paul Jolles, MD, Virginia Commonwealth University |
| MCC-8029, N01CM27165 |
| Virginia Commonwealth University |
|
| Principal Investigator: |
Karen A. Kurdziel, M.D. |
Virginia Commonwealth University |
|
|
| Virginia Commonwealth University |
| March 2009 |