Phase II Study of 3'-Deoxy-3'-18F Fluorothymidine (FLT)
in Invasive Breast Cancer

Protocol Documents

Protocol-ACRIN 6688 Amendment 9, v09.20.11 [PDF]

SOC-ACRIN 6688 Amendment 9, v09.21.11 [PDF]

Informed Consent-ACRIN 6688 [DOC]

Investigator's Brochure: FLT, version May 2011 [PDF]

VCU Principal Investigator: Paul R. Jolles, MD

ACRIN Principal Co-Investigators: 
David Mankoff, MD, PhD, and Lale Kostakoglu, MD, MPH

Status: In Analysis

Main Objective: To evaluate the relationship between [18F]FLT uptake parameters and
pathologic complete response to neoadjuvant therapy of the primary tumor in patients
with locally advanced breast cancer.

Design Summary: Patients with locally advanced breast cancer who are candidates for
primary systemic (neoadjuvant) therapy and for whom subsequent definitiate surgery
is planned (according to current clinical guidelines) may be eligible for this trial. Participants
will be required to have three 2-day imaging sessions using FLT and FDG-PET/CT to evaluate
therapy response (baseline, mid-treatment, and just prior to surgical resection of residual tumor).