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Safety and Efficacy Study of FLT Radiolabeled Imaging Agent With PET Scan in Invasive Breast Cancer
This study is currently recruiting participants.
Study NCT00572728   Information provided by Virginia Commonwealth University
First Received: December 11, 2007   Last Updated: March 6, 2009   History of Changes

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
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
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
Contact: Paul R. Jolles, M.D. 804-828-7975 prjolles@vcu.edu
Contact: Kristin Schmidt 804-828-4178 kschmidt@vcu.edu
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP