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NCT01806675 · OUTCOME

Change in Tumor Size

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
centimeters
Interval / dispersion
Standard Deviation
Time frame
9 to 12 weeks

What was measured

The treatment effect for participants with gynecological cancers (GYN) and renal cell carcinoma (RCC) was assessed on the basis of change in tumor size as determined by pre- and post-treatment CT scans. The outcome is reported as the difference at treatment follow-up, reported as the median with standard deviation.

Analysis population: This assessment was restricted to gynecological cancers and renal cell carcinoma participants only. Tumor response data was not available for all participants in these groups.

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)0
Gynecological Cancers3
Renal Cell Cancer (RCC)3

Reported measurements

Source class 1
Values in centimeters · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Gynecological Cancers0.91.56Not reportedNot reportedNot reported
Renal Cell Cancer (RCC)11.56Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        spread
        1.56
        value
        0.9
      2. group Id
        OG002
        spread
        1.56
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    units
    Participants
description
The treatment effect for participants with gynecological cancers (GYN) and renal cell carcinoma (RCC) was assessed on the basis of change in tumor size as determined by pre- and post-treatment CT scans. The outcome is reported as the difference at treatment follow-up, reported 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
This assessment was restricted to gynecological cancers and renal cell carcinoma participants only. Tumor response data was not available for all participants in these groups.
reporting Status
POSTED
time Frame
9 to 12 weeks
title
Change in Tumor Size
type
SECONDARY
unit Of Measure
centimeters

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

Preserved source evidence · Not medical advice