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NCT00721799 · OUTCOME

Efficacy of FLT Flux (K-FLT) Mid-therapy in Predicting Overall Survival (OS).

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
mL/g/min
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).Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. FLT uptake in the tumor is a dynamic process that involves facilitated diffusion in and out of the cell and molecular changes in FLT. The rate K-FLT, measured in mL/g/min, is a composite of the rate of transport of FLT from blood into the tissue and the transfer from tissue back into the blood, as well as the rate of molecular change of FLT.

Analysis population: Participants who underwent the 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 mL/g/min · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
FLT PET Scan0.040.02Not 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
    0.67
    param Type
    Hazard Ratio (HR)
    param Value
    0.81
    statistical Method
    Regression, Cox
  2. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.11
    param Type
    C-statistic
    param Value
    0.71
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.67
    param Type
    Hazard Ratio (HR)
    param Value
    0.81
    statistical Method
    Regression, Cox
  2. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.11
    param Type
    C-statistic
    param Value
    0.71
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.02
        value
        0.04
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).Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. FLT uptake in the tumor is a dynamic process that involves facilitated diffusion in and out of the cell and molecular changes in FLT. The rate K-FLT, measured in mL/g/min, is a composite of the rate of transport of FLT from blood into the tissue and the transfer from tissue back into the blood, as well as the rate of molecular change of FLT.
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 the mid-therapy FLT PET scan
reporting Status
POSTED
time Frame
36 months
title
Efficacy of FLT Flux (K-FLT) Mid-therapy in Predicting Overall Survival (OS).
type
PRIMARY
unit Of Measure
mL/g/min

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

Preserved source evidence · Not medical advice