Safety and Efficacy Study of FLT Radiolabeled Imaging Agent With PET Scan in Invasive Breast Cancer

This study is currently recruiting participants.

Verified April 2012 by American College of Radiology Imaging Network

First Received on December 11, 2007. Last Updated on April 20, 2012 History of Changes

Sponsor:	American College of Radiology Imaging Network
Collaborator:	Virginia Commonwealth University
Information provided by (Responsible Party):	American College of Radiology Imaging Network
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 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Screening
Official Title:	A Phase II Study of 3'-Deoxy-3'-18F Fluorothymidine (FLT) in Invasive Breast

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by American College of Radiology Imaging Network:

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:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A 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 Other Names: FLT 18F-FLT 3'-Deoxy-3'-18F Fluorothymidine Drug: 3'-Deoxy-3'-18F Fluorothymidine 0.7 mCi/kg Other Name: FLT

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: Megan Quinn	804-828-8196	mmquinn@vcu.edu

Locations

United States, Virginia
Virginia Commonwealth University	Recruiting
Richmond, Virginia, United States, 23298
Principal Investigator: Paul R. Jolles, MD

Sponsors and Collaborators

American College of Radiology Imaging Network

Virginia Commonwealth University

Investigators

Study Chair:

Lale Kostakoglu, MD, MPH

ACRIN

More Information

No publications provided

Responsible Party:	American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:	NCT00572728 History of Changes
Obsolete Identifiers:	NCT00566293
Other Study ID Numbers:	MCC-8029, N01CM27165, ACRIN-6688
Study First Received:	December 11, 2007
Last Updated:	April 20, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by American College of Radiology Imaging Network:

18F-FLT
Fluorothymidine
breast cancer
PET imaging

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 22, 2012