Clinical trial NCT04411966: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Breast Cancer
Keywords: 18F-fluorothymidine
18F-fluorodeoxyglucose
Metastatic Breast Cancer
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 32
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Intervention model description: Participant received 18F-FLT and 18F-FDG at baseline, after 1st cycle , and after 2nd cycle of systemic chemotherapy.
Primary purpose: DIAGNOSTIC

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).

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

Primary outcomes:
measure: Change in 18F-fluorothymidine (18F-FLT) and 18F-fluorodeoxyglucose (18F-FDG) maximal standardized uptake value (SUV) as response to therapy
timeFrame: Baseline, post 1-cycle and post 2-cycle (at least 10 days prior to or after systemic chemotherapy, each cycle is 28 days)
Secondary outcomes:
measure: 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
timeFrame: Baseline, post 1-cycle and post 2-cycle (at least 10 days prior to or after systemic chemotherapy, , each cycle is 28 days)
Other outcomes:
measure: Progression-free survival (PFS) was defined as the time from the date of inclusion in the study to disease recurrence or progression.
timeFrame: Baseline, post 1-cycle and post 2-cycle (at least 10 days prior to or after systemic chemotherapy, each cycle is 28 days)
measure: 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.
timeFrame: Baseline, post 1-cycle and post 2-cycle (at least 10 days prior to or after systemic chemotherapy, each cycle is 28 days)
Locations:
Study officials:
References:
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.