Phase II Study of Fluorine-18 3'-Deoxy-3'-Fluorothymidine (F-18-FLT) in Invasive Breast Cancer
3'-Deoxy-3'-18F Fluorothymidine PET/CT in Predicting Response To Chemotherapy Before Surgery in Patients With Locally Advanced Breast Cancer
4 other identifiers
interventional
90
1 country
27
Brief Summary
This phase II trial studies how well 3'-deoxy-3'-18F fluorothymidine (18F-FLT) positron emission tomography (PET)/computed tomography (CT) works in predicting response in patients receiving chemotherapy and undergoing surgery for breast cancer that has spread from where it started to nearby tissue or lymph nodes. Diagnostic procedures, such as 18F-FLT PET/CT, may help in learning how well chemotherapy works to kill breast cancer cells before surgery and help doctors plan the best treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2008
Longer than P75 for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2007
CompletedFirst Posted
Study publicly available on registry
December 13, 2007
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedResults Posted
Study results publicly available
January 20, 2016
CompletedDecember 30, 2016
December 1, 2016
5.8 years
December 11, 2007
March 18, 2015
December 28, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
%Change in FLT Uptake Between the Baseline (Pre-therapy) and the Early-therapy Imaging Studies to Predict Pathological Complete Response
The primary statistical evaluation will be based on the percent change in FLT SUV60 between baseline (pre-therapy, FLT-1) and the early-therapy imaging (5-10 days after chemotherapy, FLT-2) studies
Baseline (FLT-1) to early therapy (5-10 days after chemotherapy, FLT-2)
Secondary Outcomes (8)
Correlation Between SUVmax and Ki-67 LI at FLT1(Baseline PET)
Baseline (FLT-1)
Correlation Between SUVmax and Ki-67 LI at FLT3 (Post-NAC)
Post-NAC (FLT3)
SUVmax at FLT-1 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III
Baseline (FLT-1)
SUVmax at FLT-2 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III
early treatment (FLT2)
SUVmax at FLT-3 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III
post-NAC (FLT-3)
- +3 more secondary outcomes
Study Arms (1)
Diagnostic (18F-FLT)
EXPERIMENTALPatients undergo 18F-FLT PET /CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.
Interventions
Undergo 18F-FLT PET/CT
Undergo 18F-FLT PET/CT
Undergo 18F-FLT PET/CT
Eligibility Criteria
You may qualify if:
- 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
- Locally advanced breast cancer, not stage IV, and with a tumor size \>= 2 cm (as measured on imaging or estimated by physical exam)
- No obvious contraindications for primary chemotherapy
- Residual tumor planned to be removed surgically following completion of neoadjuvant therapy
- Able to lie still for 1.5 hours for PET scanning
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
- Leukocytes \>= 3,000/ul
- Absolute neutrophil count \>= 1,500/ul
- Platelets \>= 100,000/ul
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 times the institutional upper limit of normal
- Creatinine within normal institutional limits OR creatinine clearance \>= 30 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
- If female, postmenopausal for a minimum of one year, OR surgically sterile, OR not pregnant, confirmed by institutional standard of care (SOC) pregnancy test, and willing to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation
- Able to understand and willing to sign a written informed consent document and a Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
You may not qualify if:
- Previous treatment (chemotherapy, radiation, or surgery) to involved breast; including hormone therapy
- 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 and/or unable to lie still for 1.5 hours
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to F-18 fluorothymidine
- Pregnant or nursing
- Previous malignancy, other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, from which the patient has been disease free for less than 5 years
- Currently on hormone therapy as the primary systemic neoadjuvant therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Scottsdale Medical Imaging Limited
Scottsdale, Arizona, 85251, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
Morton Plant Mease
Dunedin, Florida, 34695, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Siteman Cancer Center at Washington University
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Radiology Consultants Inc
Youngstown, Ohio, 44512, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
American College of Radiology Imaging Network
Philadelphia, Pennsylvania, 19103, United States
Hospital of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Excel Diagnostics
Houston, Texas, 77042, United States
Westchase Oncology Center
Houston, Texas, 77042, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Related Publications (1)
Kostakoglu L, Duan F, Idowu MO, Jolles PR, Bear HD, Muzi M, Cormack J, Muzi JP, Pryma DA, Specht JM, Hovanessian-Larsen L, Miliziano J, Mallett S, Shields AF, Mankoff DA; ACRIN 668 Investigative Team. A Phase II Study of 3'-Deoxy-3'-18F-Fluorothymidine PET in the Assessment of Early Response of Breast Cancer to Neoadjuvant Chemotherapy: Results from ACRIN 6688. J Nucl Med. 2015 Nov;56(11):1681-9. doi: 10.2967/jnumed.115.160663. Epub 2015 Sep 10.
PMID: 26359256RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ben Herman
- Organization
- ACRIN
Study Officials
- PRINCIPAL INVESTIGATOR
Lale Kostakoglu
American College of Radiology Imaging Network
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2007
First Posted
December 13, 2007
Study Start
December 1, 2008
Primary Completion
September 1, 2014
Study Completion
October 1, 2014
Last Updated
December 30, 2016
Results First Posted
January 20, 2016
Record last verified: 2016-12