Skip to content
← Full study record

NCT01843673 · OUTCOME

Differences of Calculated Set up Errors of 2 mm Between the Different Imaging Technologies

Image-Guided Adaptive Radiotherapy for in Detecting Tumors During Treatment in Patients With Head and Neck Cancer · Source last updated 2016-07-06

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

Measure
MEAN
Unit
mm
Interval / dispersion
Standard Deviation
Time frame
up to 7 weeks

What was measured

The automated patient setup procedure varies between 'OBI', 'CBCT' or 'Exactrac' imaging technologies. Each procedure gives two shifts: 'vertical' and 'lateral'. In the absence of a gold standard, our goal is to compare the shifts recommended by each pair of automated patient setup procedures. Average and Std deviation of vertical and lateral motion from the three systems were computed. P value, 1.00, refers to the test of difference of each system with OBI being more than 2 mm. Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. The reported mean value represents the shift from planned treatment position averaged over all daily treatment setups. A negative mean vertical value indicates the patient was consistently set up posterior to plan; a negative mean lateral value indicates a set up consistently right of plan.

Analysis population: Ten evaluable head and neck patients treated with external beam radiation therapy received 19 to 32 fractions with all three imaging techniques. The mean daily shift of these 19 to 32 fractions were recorded for each technique. Statistical significance is determined based on 5% level of significance.

Groups in this outcome

Orthogonal Varian kV OBI Image

Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure OBI gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.

Varian CBCT (Cone Beam CT) Imaging

Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure CBCT gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.

Oblique Brainlab ExacTrac Images

Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure ExacTrac gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.

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

Analysis denominator · Participants

GroupSource count
Orthogonal Varian kV OBI Image10
Varian CBCT (Cone Beam CT) Imaging10
Oblique Brainlab ExacTrac Images10

Reported measurements

Vertical shift
Values in mm · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Orthogonal Varian kV OBI Image-1.23.1Not reportedNot reportedNot reported
Varian CBCT (Cone Beam CT) Imaging-0.83.4Not reportedNot reportedNot reported
Oblique Brainlab ExacTrac Images-1.83.2Not reportedNot reportedNot reported
Lateral shift
Values in mm · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Orthogonal Varian kV OBI Image-1.53.3Not reportedNot reportedNot reported
Varian CBCT (Cone Beam CT) Imaging-1.13.3Not reportedNot reportedNot reported
Oblique Brainlab ExacTrac Images1.33.9Not reportedNot reportedNot reported

Source statistical analyses

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

  1. group Description
    Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. Clinical significance is based on a 2 mm difference. Statistical significance is determined based on 5% level of significance.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Statistical significance testing at 5% level of significance, p-value being larger than 0.05 . The p-values for pairwise comparison.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    p Value
    1.00
    p Value Comment
    Statistical significance testing at 5% level of significance, p-value being larger than 0.05. The p-values for pairwise comparison lateral and vertical, for OBI and CBCT was 1.00.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    true
  2. group Description
    Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. Clinical significance is based on a 2 mm difference. Statistical significance is determined based on 5% level of significance.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Comment
    Statistical significance testing at 5% level of significance, p-value being larger than 0.05. Those are the p-values for pairwise comparison.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    p Value
    1.00
    p Value Comment
    Statistical significance testing at 5% level of significance, p-value being larger than 0.05. The p-values for pairwise comparison lateral and vertical, for OBI and ExacTrac was 1.00.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    true
Complete source fields
analyses
  1. group Description
    Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. Clinical significance is based on a 2 mm difference. Statistical significance is determined based on 5% level of significance.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Statistical significance testing at 5% level of significance, p-value being larger than 0.05 . The p-values for pairwise comparison.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    p Value
    1.00
    p Value Comment
    Statistical significance testing at 5% level of significance, p-value being larger than 0.05. The p-values for pairwise comparison lateral and vertical, for OBI and CBCT was 1.00.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    true
  2. group Description
    Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. Clinical significance is based on a 2 mm difference. Statistical significance is determined based on 5% level of significance.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Comment
    Statistical significance testing at 5% level of significance, p-value being larger than 0.05. Those are the p-values for pairwise comparison.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    p Value
    1.00
    p Value Comment
    Statistical significance testing at 5% level of significance, p-value being larger than 0.05. The p-values for pairwise comparison lateral and vertical, for OBI and ExacTrac was 1.00.
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    true
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.1
        value
        -1.2
      2. group Id
        OG001
        spread
        3.4
        value
        -0.8
      3. group Id
        OG002
        spread
        3.2
        value
        -1.8
    title
    Vertical shift
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.3
        value
        -1.5
      2. group Id
        OG001
        spread
        3.3
        value
        -1.1
      3. group Id
        OG002
        spread
        3.9
        value
        1.3
    title
    Lateral shift
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      10
    units
    Participants
description
The automated patient setup procedure varies between 'OBI', 'CBCT' or 'Exactrac' imaging technologies. Each procedure gives two shifts: 'vertical' and 'lateral'. In the absence of a gold standard, our goal is to compare the shifts recommended by each pair of automated patient setup procedures. Average and Std deviation of vertical and lateral motion from the three systems were computed. P value, 1.00, refers to the test of difference of each system with OBI being more than 2 mm. Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. The reported mean value represents the shift from planned treatment position averaged over all daily treatment setups. A negative mean vertical value indicates the patient was consistently set up posterior to plan; a negative mean lateral value indicates a set up consistently right of plan.
dispersion Type
Standard Deviation
groups
  1. description
    Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure OBI gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
    id
    OG000
    title
    Orthogonal Varian kV OBI Image
  2. description
    Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure CBCT gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
    id
    OG001
    title
    Varian CBCT (Cone Beam CT) Imaging
  3. description
    Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure ExacTrac gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
    id
    OG002
    title
    Oblique Brainlab ExacTrac Images
param Type
MEAN
population Description
Ten evaluable head and neck patients treated with external beam radiation therapy received 19 to 32 fractions with all three imaging techniques. The mean daily shift of these 19 to 32 fractions were recorded for each technique. Statistical significance is determined based on 5% level of significance.
reporting Status
POSTED
time Frame
up to 7 weeks
title
Differences of Calculated Set up Errors of 2 mm Between the Different Imaging Technologies
type
PRIMARY
unit Of Measure
mm

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

Preserved source evidence · Not medical advice