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NCT01806675 · OUTCOME

Change From Baseline in Maximum Standard Uptake Values (SUVmax)

18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy · Source last updated 2019-10-03

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

Measure
MEDIAN
Unit
ratio
Interval / dispersion
Standard Deviation
Time frame
At baseline and 6 weeks

What was measured

Maximum standard uptake values (SUVmax) were assessed on the basis of position emission tomography (PET) scans using radiotracers 18F-FPPRGD2 and 18F-FDG at baseline and at regular medical care follow-up (6 to 12 weeks after initiation of treatment). The outcome is assessed as the difference in the maximum standard uptake values (SUVmax) values from baseline to follow-up for the 2 radiotracers, and will be reported for each disease type as the median with standard deviation.

Analysis population: Some participants did not contribute some or all post-treatment scans.

Groups in this outcome

Glioblastoma Multiforme (GBM)

Patients with glioblastoma multiforme (GBM) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and 6 weeks (or standard of care follow-up) 18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan 18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2.

Gynecological Cancers

Patients with gynecological cancer undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up) 18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan 18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2.

Renal Cell Cancer (RCC)

Patients with renal cell cancer (RCC) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up) 18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan 18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2.

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

Analysis denominator · Participants

GroupSource count
Glioblastoma Multiforme (GBM)8
Gynecological Cancers4
Renal Cell Cancer (RCC)4

Reported measurements

18F-FPPRGD2 PET scans

Analysis denominator · Participants

GroupSource count
Glioblastoma Multiforme (GBM)8
Gynecological Cancers4
Renal Cell Cancer (RCC)3
Values in ratio · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Glioblastoma Multiforme (GBM)-0.980.98Not reportedNot reportedNot reported
Gynecological Cancers0.091.20Not reportedNot reportedNot reported
Renal Cell Cancer (RCC)0.100.29Not reportedNot reportedNot reported
18F-FDG PET scans

Analysis denominator · Participants

GroupSource count
Glioblastoma Multiforme (GBM)0
Gynecological Cancers4
Renal Cell Cancer (RCC)3
Values in ratio · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Gynecological Cancers-1.902.80Not reportedNot reportedNot reported
Renal Cell Cancer (RCC)7.88.2Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.98
        value
        -0.98
      2. group Id
        OG001
        spread
        1.20
        value
        0.09
      3. group Id
        OG002
        spread
        0.29
        value
        0.10
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        3
      units
      Participants
    title
    18F-FPPRGD2 PET scans
  2. categories
    1. measurements
      1. group Id
        OG001
        spread
        2.80
        value
        -1.90
      2. group Id
        OG002
        spread
        8.2
        value
        7.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        3
      units
      Participants
    title
    18F-FDG PET scans
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      4
    units
    Participants
description
Maximum standard uptake values (SUVmax) were assessed on the basis of position emission tomography (PET) scans using radiotracers 18F-FPPRGD2 and 18F-FDG at baseline and at regular medical care follow-up (6 to 12 weeks after initiation of treatment). The outcome is assessed as the difference in the maximum standard uptake values (SUVmax) values from baseline to follow-up for the 2 radiotracers, and will be reported for each disease type as the median with standard deviation.
dispersion Type
Standard Deviation
groups
  1. description
    Patients with glioblastoma multiforme (GBM) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and 6 weeks (or standard of care follow-up) 18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan 18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2.
    id
    OG000
    title
    Glioblastoma Multiforme (GBM)
  2. description
    Patients with gynecological cancer undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up) 18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan 18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2.
    id
    OG001
    title
    Gynecological Cancers
  3. description
    Patients with renal cell cancer (RCC) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up) 18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan 18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2.
    id
    OG002
    title
    Renal Cell Cancer (RCC)
param Type
MEDIAN
population Description
Some participants did not contribute some or all post-treatment scans.
reporting Status
POSTED
time Frame
At baseline and 6 weeks
title
Change From Baseline in Maximum Standard Uptake Values (SUVmax)
type
PRIMARY
unit Of Measure
ratio

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Preserved source evidence · Not medical advice