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NCT00602043 · OUTCOME

Time to Progression

F-18 16 Alpha-Fluoroestradiol-Labeled Positron Emission Tomography in Predicting Response to First-Line Hormone Therapy in Patients With Stage IV Breast Cancer · Source last updated 2020-02-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
Full Range
Time frame
Up to 6 months

What was measured

FES SUV prior to endocrine treatment (dichotomized and as a continuous predictor) will also be tested as predictor of time to progression. Analysis will be conducted using (respectively) logistic regression and Cox proportional hazards regression. This will include univariate analysis of FES and other predictive measures (ER/PgR expression, serum sex steroid levels), followed by an exploratory multivariate analysis combining FES SUV with other measures showing predictive capability univariate analysis.

Groups in this outcome

Diagnostic (FES): Average FES SUVmean >1.5, no Negative Sites

Patients undergo \[\^18F\] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to \[\^18F\] FES PET scan. Patients begin clinically indicated endocrine therapy. Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT. This group represents patients who had positive FES uptake at all disease sites on the baseline diagnostic FES PET scan.

Diagnostic FES: Patients With FES Negative Sites of Disease

Patients undergo \[\^18F\] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to \[\^18F\] FES PET scan. Patients begin clinically indicated endocrine therapy. Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT. This group represents patients who had some or all disease sites negative for FES uptake on the baseline diagnostic FES PET scan.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Diagnostic (FES): Average FES SUVmean >1.5, no Negative Sites5
Diagnostic FES: Patients With FES Negative Sites of Disease2

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Diagnostic (FES): Average FES SUVmean >1.5, no Negative Sites4.9Not reported2.16.0Not reported
Diagnostic FES: Patients With FES Negative Sites of Disease2.2Not reported1.23.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.1
        upper Limit
        6.0
        value
        4.9
      2. group Id
        OG001
        lower Limit
        1.2
        upper Limit
        3.3
        value
        2.2
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      2
    units
    Participants
description
FES SUV prior to endocrine treatment (dichotomized and as a continuous predictor) will also be tested as predictor of time to progression. Analysis will be conducted using (respectively) logistic regression and Cox proportional hazards regression. This will include univariate analysis of FES and other predictive measures (ER/PgR expression, serum sex steroid levels), followed by an exploratory multivariate analysis combining FES SUV with other measures showing predictive capability univariate analysis.
dispersion Type
Full Range
groups
  1. description
    Patients undergo \[\^18F\] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to \[\^18F\] FES PET scan. Patients begin clinically indicated endocrine therapy. Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT. This group represents patients who had positive FES uptake at all disease sites on the baseline diagnostic FES PET scan.
    id
    OG000
    title
    Diagnostic (FES): Average FES SUVmean >1.5, no Negative Sites
  2. description
    Patients undergo \[\^18F\] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to \[\^18F\] FES PET scan. Patients begin clinically indicated endocrine therapy. Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT. This group represents patients who had some or all disease sites negative for FES uptake on the baseline diagnostic FES PET scan.
    id
    OG001
    title
    Diagnostic FES: Patients With FES Negative Sites of Disease
param Type
MEDIAN
reporting Status
POSTED
time Frame
Up to 6 months
title
Time to Progression
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice