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NCT00602043 · OUTCOME

Number of Participants With Clinical Benefit

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
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 clinical benefit. Patients were expected to start endocrine therapy within 2 weeks of the FES PET scan. Response assessment was evaluated at 3 and 6 months. The initial (baseline) FES uptake was compared to clinical benefit (PD versus other outcome at 6 months).

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. laboratory biomarker analysis: Correlative studies

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 Sites13
Diagnostic FES: Patients With FES Negative Sites of Disease3

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Diagnostic FES: Average FES SUVmean >1.5, no Negative Sites8Not reportedNot reportedNot reportedNot reported
Diagnostic FES: Patients With FES Negative Sites of Disease0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      3
    units
    Participants
description
FES SUV prior to endocrine treatment (dichotomized and as a continuous predictor) will also be tested as predictor of clinical benefit. Patients were expected to start endocrine therapy within 2 weeks of the FES PET scan. Response assessment was evaluated at 3 and 6 months. The initial (baseline) FES uptake was compared to clinical benefit (PD versus other outcome at 6 months).
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. laboratory biomarker analysis: Correlative studies
    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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 6 months
title
Number of Participants With Clinical Benefit
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice