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NCT02599194 · OUTCOME

Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs

18F-FSPG PET/CT for Cancer Patients on Therapy · Source last updated 2019-01-03

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

Measure
NUMBER
Unit
cm2
Interval / dispersion
Not reported
Time frame
Baseline and up to 2 years

What was measured

Lesion size in centimeters (cm) were assessed in 2 dimensions from the computed tomography (CT) component of PET/CT and the area in cm2 calculated for lesion locations at baseline and after treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported the difference in area in cm² for each lesion (a number without dispersion).

Analysis population: * Lesion locations not detected both before and after treatment are reported as N/A for 2-D area (in the effect that an assessment could be made with the other radiolabel). * Lesions detected at either before or after treatment only are reported as the difference from zero.

Groups in this outcome

Difference in Lesion Size as Detected by 18F-FSPG

Participants sequentially receive radioimaging agent 18F-FSPG IV followed by PET/CT scan with 60 minutes. 18F-FSPG: Administered intravenously (IV)

Difference in Lesion Size as Detected by 18F-FDG

Participants sequentially receive radioimaging agent 18F-FDG IV followed by PET/CT scan with 60 minutes. 18F-FDG: Administered intravenously (IV)

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

Analysis denominator · Participants

GroupSource count
Difference in Lesion Size as Detected by 18F-FSPG7
Difference in Lesion Size as Detected by 18F-FDG7

Analysis denominator · Lesion locations assessed

GroupSource count
Difference in Lesion Size as Detected by 18F-FSPG17
Difference in Lesion Size as Detected by 18F-FDG26

Reported measurements

Adrenal / adrenal mass, left
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPGNANot reportedNot reportedNot reportedLesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.
Difference in Lesion Size as Detected by 18F-FDG11.3Not reportedNot reportedNot reportedNot reported
Adrenal / hepatic dome
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPGNANot reportedNot reportedNot reportedLesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.
Difference in Lesion Size as Detected by 18F-FDG-2.0Not reportedNot reportedNot reportedNot reported
Adrenal / liver metastatis
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPGNANot reportedNot reportedNot reportedLesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.
Difference in Lesion Size as Detected by 18F-FDG-1.3Not reportedNot reportedNot reportedNot reported
Adrenal / lung base metastatis, lower lobe right
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPGNANot reportedNot reportedNot reportedLesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.
Difference in Lesion Size as Detected by 18F-FDG1.4Not reportedNot reportedNot reportedNot reported
Adrenal / lung metastatis, left
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPGNANot reportedNot reportedNot reportedLesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.
Difference in Lesion Size as Detected by 18F-FDG-0.7Not reportedNot reportedNot reportedNot reported
Lung / infrascapular subcut
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPG0.2Not reportedNot reportedNot reportedNot reported
Difference in Lesion Size as Detected by 18F-FDGNANot reportedNot reportedNot reportedLesion location was not detected by 18F-FDG both before and after treatment, and no difference can be reported for 2-D area.
Lung / abdominal wall, upper quadrant right
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPG7.6Not reportedNot reportedNot reportedNot reported
Difference in Lesion Size as Detected by 18F-FDG6.9Not reportedNot reportedNot reportedNot reported
Lung / adajcent subcarinal lymph node
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPGNANot reportedNot reportedNot reportedLesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.
Difference in Lesion Size as Detected by 18F-FDG3.0Not reportedNot reportedNot reportedNot reported
Lung / aortopulmonary window lymph node
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPG-1.1Not reportedNot reportedNot reportedNot reported
Difference in Lesion Size as Detected by 18F-FDG-2.8Not reportedNot reportedNot reportedNot reported
Lung / hilar lymph node, left
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPGNANot reportedNot reportedNot reportedLesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.
Difference in Lesion Size as Detected by 18F-FDG-2.3Not reportedNot reportedNot reportedNot reported
Lung / infraspinatus mm, right
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPG10.4Not reportedNot reportedNot reportedNot reported
Difference in Lesion Size as Detected by 18F-FDG10.2Not reportedNot reportedNot reportedNot reported
Lung / lingula nodule
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPG-1.7Not reportedNot reportedNot reportedNot reported
Difference in Lesion Size as Detected by 18F-FDG-2.7Not reportedNot reportedNot reportedNot reported
Lung / mass, upper lobe left
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPG-8.1Not reportedNot reportedNot reportedNot reported
Difference in Lesion Size as Detected by 18F-FDG-6.4Not reportedNot reportedNot reportedNot reported
Lung / mass, lower lobe right
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPGNANot reportedNot reportedNot reportedLesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.
Difference in Lesion Size as Detected by 18F-FDG-14.5Not reportedNot reportedNot reportedNot reported
Lung / nodule 1, lower lobe right
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPGNANot reportedNot reportedNot reportedLesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.
Difference in Lesion Size as Detected by 18F-FDG-0.8Not reportedNot reportedNot reportedNot reported
Lung / nodule 2, upper lobe right
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPG-1.7Not reportedNot reportedNot reportedNot reported
Difference in Lesion Size as Detected by 18F-FDG-1.5Not reportedNot reportedNot reportedNot reported
Lung / nodule, upper lobe right
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPGNANot reportedNot reportedNot reportedLesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.
Difference in Lesion Size as Detected by 18F-FDG-0.4Not reportedNot reportedNot reportedNot reported
Lung / paraesophageal lymph node
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPG0.9Not reportedNot reportedNot reportedNot reported
Difference in Lesion Size as Detected by 18F-FDGNANot reportedNot reportedNot reportedLesion location was not detected by 18F-FDG both before and after treatment, and no difference can be reported for 2-D area.
Lung / post-basal, lower lobe right
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPGNANot reportedNot reportedNot reportedLesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.
Difference in Lesion Size as Detected by 18F-FDG-3.6Not reportedNot reportedNot reportedNot reported
Lung / subcarinal lymph node
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPG1.4Not reportedNot reportedNot reportedNot reported
Difference in Lesion Size as Detected by 18F-FDG11.4Not reportedNot reportedNot reportedNot reported
Renal / adrenal mass, right
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPG3.1Not reportedNot reportedNot reportedNot reported
Difference in Lesion Size as Detected by 18F-FDG7.1Not reportedNot reportedNot reportedNot reported
Renal / aortopulmonary window lymph node, left
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPG1.1Not reportedNot reportedNot reportedNot reported
Difference in Lesion Size as Detected by 18F-FDG-1.2Not reportedNot reportedNot reportedNot reported
Renal / gluteal subcutaneous nodule
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPG0.2Not reportedNot reportedNot reportedNot reported
Difference in Lesion Size as Detected by 18F-FDG0.2Not reportedNot reportedNot reportedNot reported
Renal / interlobar
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPG2.4Not reportedNot reportedNot reportedNot reported
Difference in Lesion Size as Detected by 18F-FDGNANot reportedNot reportedNot reportedLesion location was not detected by 18F-FDG both before and after treatment, and no difference can be reported for 2-D area.
Renal / kidney midpole, right
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPG-1.2Not reportedNot reportedNot reportedNot reported
Difference in Lesion Size as Detected by 18F-FDG-1.4Not reportedNot reportedNot reportedNot reported
Renal / omental nodule
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPG-0.2Not reportedNot reportedNot reportedNot reported
Difference in Lesion Size as Detected by 18F-FDG1.2Not reportedNot reportedNot reportedNot reported
Renal / paratracheal lymph node, right
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPG0.6Not reportedNot reportedNot reportedNot reported
Difference in Lesion Size as Detected by 18F-FDG-2.0Not reportedNot reportedNot reportedNot reported
Renal / parotid, right
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPGNANot reportedNot reportedNot reportedLesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.
Difference in Lesion Size as Detected by 18F-FDG-2.3Not reportedNot reportedNot reportedNot reported
Renal / retroperitoneal lymph node, left
Values in cm2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Difference in Lesion Size as Detected by 18F-FSPG1.6Not reportedNot reportedNot reportedNot reported
Difference in Lesion Size as Detected by 18F-FDG2.2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.
        group Id
        OG000
        value
        NA
      2. group Id
        OG001
        value
        11.3
    title
    Adrenal / adrenal mass, left
  2. categories
    1. measurements
      1. comment
        Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.
        group Id
        OG000
        value
        NA
      2. group Id
        OG001
        value
        -2.0
    title
    Adrenal / hepatic dome
  3. categories
    1. measurements
      1. comment
        Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.
        group Id
        OG000
        value
        NA
      2. group Id
        OG001
        value
        -1.3
    title
    Adrenal / liver metastatis
  4. categories
    1. measurements
      1. comment
        Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.
        group Id
        OG000
        value
        NA
      2. group Id
        OG001
        value
        1.4
    title
    Adrenal / lung base metastatis, lower lobe right
  5. categories
    1. measurements
      1. comment
        Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.
        group Id
        OG000
        value
        NA
      2. group Id
        OG001
        value
        -0.7
    title
    Adrenal / lung metastatis, left
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0.2
      2. comment
        Lesion location was not detected by 18F-FDG both before and after treatment, and no difference can be reported for 2-D area.
        group Id
        OG001
        value
        NA
    title
    Lung / infrascapular subcut
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        7.6
      2. group Id
        OG001
        value
        6.9
    title
    Lung / abdominal wall, upper quadrant right
  8. categories
    1. measurements
      1. comment
        Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.
        group Id
        OG000
        value
        NA
      2. group Id
        OG001
        value
        3.0
    title
    Lung / adajcent subcarinal lymph node
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        -1.1
      2. group Id
        OG001
        value
        -2.8
    title
    Lung / aortopulmonary window lymph node
  10. categories
    1. measurements
      1. comment
        Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.
        group Id
        OG000
        value
        NA
      2. group Id
        OG001
        value
        -2.3
    title
    Lung / hilar lymph node, left
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        10.4
      2. group Id
        OG001
        value
        10.2
    title
    Lung / infraspinatus mm, right
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        -1.7
      2. group Id
        OG001
        value
        -2.7
    title
    Lung / lingula nodule
denom Units Selected
Lesion locations assessed
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      7
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      17
    2. group Id
      OG001
      value
      26
    units
    Lesion locations assessed
description
Lesion size in centimeters (cm) were assessed in 2 dimensions from the computed tomography (CT) component of PET/CT and the area in cm2 calculated for lesion locations at baseline and after treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported the difference in area in cm² for each lesion (a number without dispersion).
groups
  1. description
    Participants sequentially receive radioimaging agent 18F-FSPG IV followed by PET/CT scan with 60 minutes. 18F-FSPG: Administered intravenously (IV)
    id
    OG000
    title
    Difference in Lesion Size as Detected by 18F-FSPG
  2. description
    Participants sequentially receive radioimaging agent 18F-FDG IV followed by PET/CT scan with 60 minutes. 18F-FDG: Administered intravenously (IV)
    id
    OG001
    title
    Difference in Lesion Size as Detected by 18F-FDG
param Type
NUMBER
population Description
* Lesion locations not detected both before and after treatment are reported as N/A for 2-D area (in the effect that an assessment could be made with the other radiolabel). * Lesions detected at either before or after treatment only are reported as the difference from zero.
reporting Status
POSTED
time Frame
Baseline and up to 2 years
title
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs
type
SECONDARY
type Units Analyzed
Lesion locations assessed
unit Of Measure
cm2

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Preserved source evidence · Not medical advice