Full Text View
Tabular View
No Study Results Posted
Related Studies
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, March 2009
First Received: December 11, 2007   Last Updated: March 6, 2009   History of Changes
Sponsor: 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

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

Resource links provided by NLM:


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: February 2009
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

No publications provided

Responsible Party: Virginia Commonwealth University ( Paul Jolles, MD )
Study ID Numbers: MCC-8029, N01CM27165
Study First Received: December 11, 2007
Last Updated: March 6, 2009
ClinicalTrials.gov Identifier: NCT00572728     History of Changes
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on November 09, 2009