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NCT Number: NCT04411966

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

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18F-fluorothymidine

Diagnostic Test

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2019
First posted
Jun 2, 2020
Registry last updated
Jun 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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