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

June 1, 2020 updated by: Chang Gung Memorial Hospital

Integrating 18F-FDG PET/CT With 18F-FLT PET/CT in Predicting Treatment Response and Prognosis of Metastatic/Recurrent Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 18F-fluorothymidine PET
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.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 18F-fluorothymidine (18F-FLT) and 18F-fluorodeoxyglucose (18F-FDG) maximal standardized uptake value (SUV) as response to therapy
Time Frame: 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.
Baseline, post 1-cycle and post 2-cycle (at least 10 days prior to or after systemic chemotherapy, each cycle is 28 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
Baseline, post 1-cycle and post 2-cycle (at least 10 days prior to or after systemic chemotherapy, , each cycle is 28 days)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) was defined as the time from the date of inclusion in the study to disease recurrence or progression.
Time Frame: Baseline, post 1-cycle and post 2-cycle (at least 10 days prior to or after systemic chemotherapy, each cycle is 28 days)
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 survival outcomes
Baseline, post 1-cycle and post 2-cycle (at least 10 days prior to or after systemic chemotherapy, each cycle is 28 days)
Overall survival (OS) was defined as the time from the date of inclusion in the study to the date of death from any cause or last follow-up.
Time Frame: Baseline, post 1-cycle and post 2-cycle (at least 10 days prior to or after systemic chemotherapy, each cycle is 28 days)
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 survival outcomes
Baseline, post 1-cycle and post 2-cycle (at least 10 days prior to or after systemic chemotherapy, each cycle is 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2014

Primary Completion (ACTUAL)

August 30, 2017

Study Completion (ACTUAL)

May 30, 2019

Study Registration Dates

First Submitted

May 12, 2020

First Submitted That Met QC Criteria

June 1, 2020

First Posted (ACTUAL)

June 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 2, 2020

Last Update Submitted That Met QC Criteria

June 1, 2020

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMRPG2C0483

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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