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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.   Last updated on June 3, 2008.   Information provided by Virginia Commonwealth University

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Descriptive Information Fields
Brief Title  Safety and Efficacy Study of FLT Radiolabeled Imaging Agent With PET Scan in Invasive Breast Cancer
Official Title  A Phase II Study of 3'-Deoxy-3'-18F Fluorothymidine (FLT) in Invasive Breast
Brief Summary

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.

Detailed Description
Study Phase Phase II
Study Type  Interventional
Study Design  Screening, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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 ]
Secondary Outcome Measure  Vital signs, clinical laboratory tests, ECG [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Condition  Breast Cancer
Intervention  Drug: 3'-Deoxy-3'-18F Fluorothymidine
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  36
Start Date  November 2007
Completion Date November 2009
Eligibility Criteria 

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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Paul R. Jolles, M.D.     804-828-7975     prjolles@vcu.edu    
Contact: Kristin Schmidt     804-828-4178     kschmidt@vcu.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00572728
Organization ID MCC-8029
Secondary IDs †† N01CM27165
Study Sponsor  Virginia Commonwealth University
Collaborators ††
Investigators 
Principal Investigator:     Karen A. Kurdziel, M.D.     Virginia Commonwealth University    
Information Provided By Virginia Commonwealth University
Verification Date June 2008
First Received Date  December 11, 2007
Last Updated Date June 3, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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