Early Interim 18F-FDG-PET and 18F-FLT-PET for Predicting Treatment Response and Survival in Metastatic Breast Cancer

Not Applicable

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Diagnostic Test: 18F-fluorothymidine

• Registration Number: NCT04411966
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

We aim to investigate the value of 3'-deoxy-3'-18F-fluorothymidine (18F-FLT) and 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) for early prediction of treatment response and survival in patients with metastatic breast cancer after salvage therapy.

Detailed Description

Patients with metastatic breast cancer were enrolled and received PET/CT using 18F-FLT and 18F-FDG at baseline, after 1st cycle , and after 2nd cycle of systemic chemotherapy. The standard reference for treatment response was classified according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria for contrast-enhanced CT (CE-CT) after 3 months of systemic chemotherapy. The metabolic response on PET was assessed according to PET response criteria in solid tumors (PERCIST) criteria and was correlated to the treatment response, progression-free survival (PFS), and overall survival (OS).

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2017-08-30
• Status Verified: 2018-05
• Study Completion: 2019-05-30
• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-06-01
• Last Update Submitted: 2020-06-01
• Study First Posted: 2020-06-02
• Last Update Posted: 2020-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

• Participants must have histological evidence of breast cancer of any stage
• Participants must be diagnosed with metastatic breast cancer
• Participants should be willing and able to have both PET-CT scans
• Participants should be eligible for and plan to undergo systemic chemotherapy and should be seen by a oncologist prior to beginning the study
• Participants should have the ability to understand and the willingness to sign a written informed consent document
• Participants must sign a study specific consent form prior to registration

Exclusion Criteria

• Patients have been diagnosed with other malignancy
• Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or significant inflammation at treatment site or psychiatric illness/social situations that would limit compliance with study requirements or whose lab values do not meet the criteria above are excluded
• Pregnant women are excluded from this study
• Breast feeding women are excluded from this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
18F-fluorothymidine PET	18F-fluorothymidine	Patients receive fluorothymidine F-18 IV over 1 minute and undergo PET scan over 60 minutes at least 10 days prior to systemic chemotherapy, and at least 10 days after first and second cycles of systemic chemotherapy.

Primary Outcome Measures

Name	Time	Method
Change in 18F-fluorothymidine (18F-FLT) and 18F-fluorodeoxyglucose (18F-FDG) maximal standardized uptake value (SUV) as response to therapy	Baseline, post 1-cycle and post 2-cycle (at least 10 days prior to or after systemic chemotherapy, each cycle is 28 days)	The response to therapy would be determined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) by contrast-enhanced computed tomography (CE-CT). The change of SUVmax between the responders and non responders on 18F-FLT and 18F-FDG would be compared.

Secondary Outcome Measures

Name	Time	Method
Compare Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) and European Organization for Research and Treatment of Cancer (EORCT) response by 18F-FLT-PET and 18F-FDG-PET for the prediction of anatomic treatment response	Baseline, post 1-cycle and post 2-cycle (at least 10 days prior to or after systemic chemotherapy, , each cycle is 28 days)	We will use both EORTC and PERCIST criteria to compare the 18F-FLT-PET and 18F-FDG-PET metabolic response for the predictions of anatomic treatment response. Receiver operating characteristic (ROC) curve analysis and comparison were performed to evaluate the performance of 18F-FLT-PET and 18F-FDG-PET in predicting the anatomic treatment response, both with EORTC and PERCIST criteria.