NCT01553149 · OUTCOME

Magnetic Resonance Imaging Sequence

Low-Dose or High-Dose Lenalidomide in Treating Younger Patients With Recurrent, Refractory, or Progressive Pilocytic Astrocytoma or Optic Pathway Glioma · Source last updated 2025-01-07

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

Measure: NUMBER
Unit: Number of scans in agreement
Interval / dispersion: Not reported
Time frame: Up to 3 years

What was measured

Response categories (complete response, partial response, stable disease, and progression) will be determined from the following three standard magnetic resonance sequences, T2-weighted, fluid attenuated inversion recovery, T1-weighted post-contrast. Percent agreement between the sequences will be estimated as the number of follow-up scans in which the corresponding sequence agreed divided by the total number of follow-up scans.

Analysis population: Scans completed and reviewed by standard magnetic resonance sequences. Only eligible patients are considered in the analysis of this outcome measure.

Groups in this outcome

Arm I (Low-dose Lenalidomide)

Patients receive low-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Pharmacological Study: Correlative studies

Arm II (High-dose Lenalidomide)

Patients receive high-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Pharmacological Study: Correlative studies

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

Analysis denominator · Participants

Group	Source count
Arm I (Low-dose Lenalidomide)	30
Arm II (High-dose Lenalidomide)	25

Analysis denominator · Scans

Group	Source count
Arm I (Low-dose Lenalidomide)	110
Arm II (High-dose Lenalidomide)	77

Reported measurements

T1-weighted post-contrast and fluid attenuated inversion recovery

Analysis denominator · Participants

Group	Source count
Arm I (Low-dose Lenalidomide)	25
Arm II (High-dose Lenalidomide)	23

Analysis denominator · Scans

Group	Source count
Arm I (Low-dose Lenalidomide)	64
Arm II (High-dose Lenalidomide)	63

Values in Number of scans in agreement · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Low-dose Lenalidomide)	35	Not reported	Not reported	Not reported	Not reported
Arm II (High-dose Lenalidomide)	43	Not reported	Not reported	Not reported	Not reported

T1-weighted post-contrast and T2-weighted

Analysis denominator · Participants

Group	Source count
Arm I (Low-dose Lenalidomide)	25
Arm II (High-dose Lenalidomide)	23

Analysis denominator · Scans

Group	Source count
Arm I (Low-dose Lenalidomide)	64
Arm II (High-dose Lenalidomide)	63

Values in Number of scans in agreement · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Low-dose Lenalidomide)	35	Not reported	Not reported	Not reported	Not reported
Arm II (High-dose Lenalidomide)	42	Not reported	Not reported	Not reported	Not reported

Fluid attenuated inversion recovery and T2-weighted

Analysis denominator · Participants

Group	Source count
Arm I (Low-dose Lenalidomide)	29
Arm II (High-dose Lenalidomide)	25

Analysis denominator · Scans

Group	Source count
Arm I (Low-dose Lenalidomide)	108
Arm II (High-dose Lenalidomide)	77

Values in Number of scans in agreement · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Low-dose Lenalidomide)	66	Not reported	Not reported	Not reported	Not reported
Arm II (High-dose Lenalidomide)	60	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
35
group Id
OG001
value
43
denoms
counts
group Id
OG000
value
25
group Id
OG001
value
23
units
Participants
counts
group Id
OG000
value
64
group Id
OG001
value
63
units
Scans
title
T1-weighted post-contrast and fluid attenuated inversion recovery
categories
measurements
group Id
OG000
value
35
group Id
OG001
value
42
denoms
counts
group Id
OG000
value
25
group Id
OG001
value
23
units
Participants
counts
group Id
OG000
value
64
group Id
OG001
value
63
units
Scans
title
T1-weighted post-contrast and T2-weighted
categories
measurements
group Id
OG000
value
66
group Id
OG001
value
60
denoms
counts
group Id
OG000
value
29
group Id
OG001
value
25
units
Participants
counts
group Id
OG000
value
108
group Id
OG001
value
77
units
Scans
title
Fluid attenuated inversion recovery and T2-weighted

denom Units Selected

Scans

denoms

counts
group Id
OG000
value
30
group Id
OG001
value
25
units
Participants
counts
group Id
OG000
value
110
group Id
OG001
value
77
units
Scans

description

groups

description
Patients receive low-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Pharmacological Study: Correlative studies
id
OG000
title
Arm I (Low-dose Lenalidomide)
description
Patients receive high-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Pharmacological Study: Correlative studies
id
OG001
title
Arm II (High-dose Lenalidomide)

param Type

NUMBER

population Description

Scans completed and reviewed by standard magnetic resonance sequences. Only eligible patients are considered in the analysis of this outcome measure.

reporting Status

POSTED

time Frame

Up to 3 years

title

Magnetic Resonance Imaging Sequence

type

SECONDARY

type Units Analyzed

Scans

unit Of Measure

Number of scans in agreement

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

Preserved source evidence · Not medical advice