CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
18F-FLT-PET/CT Imagingradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01015131
NCT01015131Phase 2Completed
CompareCT.gov

A Pilot Study to Evaluate the Correlation Between 18F-FLT-PET Uptake, Ki-67 Immunohistochemistry, and Proliferation Signature in Response to Neo-Adjuvant Chemotherapy in Breast Cancer

Merck Sharp & Dohme LLC·interventional·Posted Nov 18, 2009·Updated Feb 11, 2021

In Brief

A Phase 2 clinical trial evaluating 18F-FLT-PET/CT Imaging for Breast Cancer. Completed, enrolled 46 participants.

Detailed Summary

This study correlated changes from baseline in Ki-67, an immunohistochemical marker of cell proliferation, with changes from baseline in tumor uptake of 3'-deoxy-3'\[18F\]-fluorothymidine (18F-FLT) following the first cycle of treatment with standard of care neo-adjuvant therapy in participants with breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 18, 2009
Enrollment StartApr 8, 2010
Primary CompletionMay 24, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 16.6 years ago

Interventions

18F-FLT-PET/CT Imagingradiation

Participants receive the investigational radiotracer 18F-FLT intravenously and undergo Positron Emission Tomography (PET)/Computed Tomography (CT) scans at the following three times: prior to initiation of chemotherapy, at the end of the first cycle of treatment, and at the conclusion of chemotherapy.