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NCT00721799 · OUTCOME

Efficacy of Percent Change in Mean FLT Uptake (SUVmean) Between Scan 1 & 2 in Predicting Progression Free Survival (PFS)

F-18 Fluorothymidine PET Imaging for Early Evaluation of Response to Therapy in Head & Neck Cancer Patients · Source last updated 2019-08-06

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

Measure
MEAN
Unit
percentage change in SUVmean
Interval / dispersion
Standard Deviation
Time frame
36 months

What was measured

Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.

Analysis population: Participants who underwent both the pre-therapy and mid-therapy FLT PET scan

Groups in this outcome

FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans * Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy) * Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation) F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%). Imaging technology: 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
FLT PET Scan25

Reported measurements

Source class 1
Values in percentage change in SUVmean · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
FLT PET Scan-0.390.18Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.18
    param Type
    Hazard Ratio (HR)
    param Value
    1.58
    statistical Method
    Regression, Cox
  2. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.25
    param Type
    C-statistic
    param Value
    0.63
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.18
    param Type
    Hazard Ratio (HR)
    param Value
    1.58
    statistical Method
    Regression, Cox
  2. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.25
    param Type
    C-statistic
    param Value
    0.63
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.18
        value
        -0.39
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    units
    Participants
description
Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.
dispersion Type
Standard Deviation
groups
  1. description
    Subjects receive 2 18F-Fluorothymidine PET scans * Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy) * Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation) F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%). Imaging technology: PET scan
    id
    OG000
    title
    FLT PET Scan
param Type
MEAN
population Description
Participants who underwent both the pre-therapy and mid-therapy FLT PET scan
reporting Status
POSTED
time Frame
36 months
title
Efficacy of Percent Change in Mean FLT Uptake (SUVmean) Between Scan 1 & 2 in Predicting Progression Free Survival (PFS)
type
PRIMARY
unit Of Measure
percentage change in SUVmean

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice