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

Primary Purpose

Metastatic Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
18F-fluorothymidine
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Metastatic Breast Cancer focused on measuring 18F-fluorothymidine, 18F-fluorodeoxyglucose, Metastatic Breast Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    18F-fluorothymidine PET

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Change in 18F-fluorothymidine (18F-FLT) and 18F-fluorodeoxyglucose (18F-FDG) maximal standardized uptake value (SUV) as response to therapy
    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

    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
    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.

    Full Information

    First Posted
    May 12, 2020
    Last Updated
    June 1, 2020
    Sponsor
    Chang Gung Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04411966
    Brief Title
    Early Interim 18F-FDG-PET and 18F-FLT-PET for Predicting Treatment Response and Survival in Metastatic Breast Cancer
    Official Title
    Integrating 18F-FDG PET/CT With 18F-FLT PET/CT in Predicting Treatment Response and Prognosis of Metastatic/Recurrent Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2014 (Actual)
    Primary Completion Date
    August 30, 2017 (Actual)
    Study Completion Date
    May 30, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chang Gung Memorial Hospital

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metastatic Breast Cancer
    Keywords
    18F-fluorothymidine, 18F-fluorodeoxyglucose, Metastatic Breast Cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Model Description
    Participant received 18F-FLT and 18F-FDG at baseline, after 1st cycle , and after 2nd cycle of systemic chemotherapy.
    Masking
    None (Open Label)
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    18F-fluorothymidine PET
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    18F-fluorothymidine
    Intervention Description
    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 Measure Information:
    Title
    Change in 18F-fluorothymidine (18F-FLT) and 18F-fluorodeoxyglucose (18F-FDG) maximal standardized uptake value (SUV) as response to therapy
    Description
    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.
    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)
    Secondary Outcome Measure Information:
    Title
    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
    Description
    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.
    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)
    Other Pre-specified Outcome Measures:
    Title
    Progression-free survival (PFS) was defined as the time from the date of inclusion in the study to disease recurrence or progression.
    Description
    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
    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)
    Title
    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.
    Description
    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
    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)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34376155
    Citation
    Su TP, Huang JS, Chang PH, Lui KW, Hsieh JC, Ng SH, Chan SC. Prospective comparison of early interim 18F-FDG-PET with 18F-FLT-PET for predicting treatment response and survival in metastatic breast cancer. BMC Cancer. 2021 Aug 10;21(1):908. doi: 10.1186/s12885-021-08649-z.
    Results Reference
    derived

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

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