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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.
Verified by Virginia Commonwealth University, June 2008

Sponsored by: Virginia Commonwealth University
Information provided by: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00572728
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: 3'-Deoxy-3'-18F Fluorothymidine
Phase II

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Screening, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Phase II Study of 3'-Deoxy-3'-18F Fluorothymidine (FLT) in Invasive Breast

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • 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 Measures:
  • Vital signs, clinical laboratory tests, ECG [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   36
Study Start Date:   November 2007
Estimated Study Completion Date:   November 2009
Estimated Primary Completion Date:   November 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Experimental
3'-Deoxy-3'-18F Fluorothymidine
Drug: 3'-Deoxy-3'-18F Fluorothymidine
0.07 mCi/kg with a maximum of 5 mCi frequency: before chemotherapy, mid-treatment, and just prior to surgical resection of residual tumor
Drug: 3'-Deoxy-3'-18F Fluorothymidine
0.7 mCi/kg

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572728

Contacts
Contact: Paul R. Jolles, M.D.     804-828-7975     prjolles@vcu.edu    
Contact: Kristin Schmidt     804-828-4178     kschmidt@vcu.edu    

Locations
United States, Virginia
Virginia Commonwealth University     Recruiting
      Richmond, Virginia, United States, 23298
      Principal Investigator: Karen A. Kurdziel, M.D.            

Sponsors and Collaborators
Virginia Commonwealth University

Investigators
Principal Investigator:     Karen A. Kurdziel, M.D.     Virginia Commonwealth University    
  More Information

Responsible Party:   Virginia Commonwealth University ( Paul Jolles, MD )
Study ID Numbers:   MCC-8029, N01CM27165
First Received:   December 11, 2007
Last Updated:   June 3, 2008
ClinicalTrials.gov Identifier:   NCT00572728
Health Authority:   United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
18F-FLT  
Fluorothymidine  
breast cancer  
PET imaging  

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on September 05, 2008




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