Trial Outcomes & Findings for MRI Scans in Evaluating the Effects of Radiation Therapy and Chemotherapy in Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Glioma (NCT NCT00756106)

Last Updated: 2020-05-13

Results Overview

Relative cerebral blood volume (rCBV) is the blood volume in the region of interest (ROI) divided by the blood volume in the symmetrical region on the other side of the normal brain (control region). CBV was assessed using spin-echo post-contrast T1-weighted images. Multiple images were used to assess each participant at every time-point and the median value for each participant was calculated by time-point. The data presented represent the average of those median values at each time-point. The baseline value was measured twice (representing baseline 1 and 2) to make sure that the value was reproducible and to account for any variation attributable to measurement variation. CRT: Chemoradiotherapy Cx: The cycle number TMZ: temozolomide

Recruitment status

TERMINATED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

Baseline, weekly during treatment, monthly following treatment for up to six months

Results posted on

2020-05-13

Participant Flow

Participant milestones

Participant milestones
Measure	Temozolomide and Radiation Therapy temozolomide: Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator. Imaging biomarker analysis: MRI Photon Radiation Therapy: Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions.
Overall Study STARTED	15
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MRI Scans in Evaluating the Effects of Radiation Therapy and Chemotherapy in Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Glioma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Temozolomide and Radiation Therapy n=14 Participants temozolomide: Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator. Imaging biomarker analysis: MRI Photon Radiation Therapy: Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions.
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants
Karnofsky Performance Status	90 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: Baseline, weekly during treatment, monthly following treatment for up to six months

Population: One participant withdrew consent after baseline and was excluded from the analysis set. The number of patients evaluated decreased over time due to participants experiencing disease progression and discontinuing from the study

Outcome measures

Outcome measures
Measure	Temozolomide and Radiation Therapy n=14 Participants temozolomide: Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator. Imaging biomarker analysis: MRI Photon Radiation Therapy: Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions.
Relative Cerebral Blood Volume as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Week 3 CRT	0.88 ratio Interval 0.39 to 1.58
Relative Cerebral Blood Volume as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Week 4 CRT	0.83 ratio Interval 0.43 to 1.24
Relative Cerebral Blood Volume as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Week 5 CRT	0.86 ratio Interval 0.43 to 1.33
Relative Cerebral Blood Volume as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Week 6 CRT	0.76 ratio Interval 0.41 to 1.21
Relative Cerebral Blood Volume as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Pre-C2 TMZ	0.61 ratio Interval 0.45 to 0.83
Relative Cerebral Blood Volume as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Pre-C4 TMZ	0.65 ratio Interval 0.38 to 0.87
Relative Cerebral Blood Volume as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Pre-C5 TMZ	0.61 ratio Interval 0.39 to 0.8
Relative Cerebral Blood Volume as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Post-TMZ	0.32 ratio Interval 0.09 to 0.56
Relative Cerebral Blood Volume as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Pre-C3 TMZ	0.59 ratio Interval 0.37 to 0.82
Relative Cerebral Blood Volume as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Pre-C6 TMZ	0.64 ratio Interval 0.18 to 1.3
Relative Cerebral Blood Volume as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Baseline 1	0.88 ratio Interval 0.5 to 1.47
Relative Cerebral Blood Volume as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Baseline 2	0.90 ratio Interval 0.36 to 1.77
Relative Cerebral Blood Volume as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Week 1 CRT	0.95 ratio Interval 0.47 to 1.78
Relative Cerebral Blood Volume as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Week 2 CRT	1.0 ratio Interval 0.63 to 1.68
Relative Cerebral Blood Volume as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Pre-C1 TMZ	0.68 ratio Interval 0.48 to 1.04

PRIMARY outcome

Timeframe: Baseline, weekly during treatment, monthly following treatment for up to six months

Relative cerebral blood flow (rCBF) is the blood flow rate (the volume of blood passing through the specified are over a specified period of time) in the region of interest (ROI) divided by the blood flow rate in the symmetrical region on the other side of the normal brain (control region). CBF was assessed using spin-echo post-contrast T1-weighted images. CBF was assessed using spin-echo post-contrast T1-weighted images. Multiple images were used to assess each participant at every time-point and the median value for each participant was calculated by time-point. The data presented represent the average of those median values at each time-point. The baseline value was measured twice (representing baseline 1 and 2) to make sure that the value was reproducible and to account for any variation attributable to measurement variation. CRT: Chemoradiotherapy Cx: The cycle number TMZ: temozolomide

Outcome measures

Outcome measures
Measure	Temozolomide and Radiation Therapy n=14 Participants temozolomide: Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator. Imaging biomarker analysis: MRI Photon Radiation Therapy: Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions.
Relative Cerebral Blood Flow as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Week 1 CRT	0.92 ratio Interval 0.59 to 1.37
Relative Cerebral Blood Flow as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Week 2 CRT	0.94 ratio Interval 0.63 to 1.51
Relative Cerebral Blood Flow as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Week 3 CRT	0.80 ratio Interval 0.46 to 1.38
Relative Cerebral Blood Flow as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Week 5 CRT	0.83 ratio Interval 0.48 to 1.3
Relative Cerebral Blood Flow as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Week 6 CRT	0.73 ratio Interval 0.52 to 1.1
Relative Cerebral Blood Flow as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Pre-C1 TMZ	0.63 ratio Interval 0.45 to 0.92
Relative Cerebral Blood Flow as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Pre-C2 TMZ	0.59 ratio Interval 0.5 to 0.69
Relative Cerebral Blood Flow as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Pre-C3 TMZ	0.60 ratio Interval 0.4 to 0.77
Relative Cerebral Blood Flow as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Pre-C4 TMZ	0.60 ratio Interval 0.52 to 0.67
Relative Cerebral Blood Flow as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Post-TMZ	0.37 ratio Interval 0.16 to 0.59
Relative Cerebral Blood Flow as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Baseline 1	0.83 ratio Interval 0.49 to 1.2
Relative Cerebral Blood Flow as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Baseline 2	0.86 ratio Interval 0.33 to 1.43
Relative Cerebral Blood Flow as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Week 4 CRT	0.79 ratio Interval 0.49 to 1.16
Relative Cerebral Blood Flow as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Pre-C5 TMZ	0.52 ratio Interval 0.33 to 0.7
Relative Cerebral Blood Flow as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy Pre-C6 TMZ	0.47 ratio Interval 0.3 to 0.66

PRIMARY outcome

Timeframe: Baseline, weekly during treatment, monthly following treatment for up to six months

Population: Data not collected

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, weekly during treatment, monthly following treatment for up to six months

Population: Data not collected

Mean transit time (MTT) corresponds to the average time, in seconds, that red blood cells spend within a determinate volume of capillary circulation.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, weekly during treatment, monthly following treatment for up to six months

Permeability-surface Area Product (Ktrans). Ktrans reflects the efflux rate of contrast from blood plasma into the tissue extravascular extracellular space (EES). Ktrans was assessed using post-contrast T1-weighted images. Multiple images were used to assess each participant at every time-point and the median value for each participant was calculated by time-point. The data presented represent the average of those median values at each time-point. CRT: Chemoradiotherapy Cx: The cycle number TMZ: temozolomide

Outcome measures

Outcome measures
Measure	Temozolomide and Radiation Therapy n=14 Participants temozolomide: Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator. Imaging biomarker analysis: MRI Photon Radiation Therapy: Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions.
Permeability-surface Area Product Before, During, and After Chemoradiotherapy Week 3 CRT	0.055 min ^-1 Interval 0.014 to 0.1
Permeability-surface Area Product Before, During, and After Chemoradiotherapy Week 4 CRT	0.053 min ^-1 Interval 0.01 to 0.107
Permeability-surface Area Product Before, During, and After Chemoradiotherapy Baseline 1	0.053 min ^-1 Interval 0.015 to 0.138
Permeability-surface Area Product Before, During, and After Chemoradiotherapy Baseline 2	0.039 min ^-1 Interval 0.012 to 0.075
Permeability-surface Area Product Before, During, and After Chemoradiotherapy Week 1 CRT	0.055 min ^-1 Interval 0.021 to 0.128
Permeability-surface Area Product Before, During, and After Chemoradiotherapy Week 2 CRT	0.048 min ^-1 Interval 0.018 to 0.105
Permeability-surface Area Product Before, During, and After Chemoradiotherapy Week 6 CRT	0.059 min ^-1 Interval 0.016 to 0.127
Permeability-surface Area Product Before, During, and After Chemoradiotherapy Pre-C1 TMZ	0.063 min ^-1 Interval 0.012 to 0.152
Permeability-surface Area Product Before, During, and After Chemoradiotherapy Pre-C2 TMZ	0.042 min ^-1 Interval 0.007 to 0.068
Permeability-surface Area Product Before, During, and After Chemoradiotherapy Pre-C4 TMZ	0.058 min ^-1 Interval 0.014 to 0.139
Permeability-surface Area Product Before, During, and After Chemoradiotherapy Pre-C5 TMZ	0.056 min ^-1 Interval 0.004 to 0.137
Permeability-surface Area Product Before, During, and After Chemoradiotherapy Post-TMZ	0.032 min ^-1 Interval 0.01 to 0.054
Permeability-surface Area Product Before, During, and After Chemoradiotherapy Week 5 CRT	0.058 min ^-1 Interval 0.009 to 0.154
Permeability-surface Area Product Before, During, and After Chemoradiotherapy Pre-C3 TMZ	0.050 min ^-1 Interval 0.025 to 0.106
Permeability-surface Area Product Before, During, and After Chemoradiotherapy Pre-C6 TMZ	0.060 min ^-1 Interval 0.008 to 0.121

PRIMARY outcome

Timeframe: Baseline, weekly during treatment, monthly following treatment for up to six months

Apparent diffusion coefficient (ADC) is a measure of the magnitude of diffusion (of water molecules) within tissue. ADC was assessed using post-contrast T1-weighted images. Multiple images were used to assess each participant at every time-point and the median value for each participant was calculated by time-point. The data presented represent the average of those median values at each time-point. CRT: Chemoradiotherapy Cx: The cycle number TMZ: temozolomide

Outcome measures

Outcome measures
Measure	Temozolomide and Radiation Therapy n=14 Participants temozolomide: Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator. Imaging biomarker analysis: MRI Photon Radiation Therapy: Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions.
Apparent Diffusion Coefficient Before, During, and After Chemoradiotherapy Baseline 2	0.00113 mm2/s Interval 0.00078 to 0.00209
Apparent Diffusion Coefficient Before, During, and After Chemoradiotherapy Week 1 CRT	0.00106 mm2/s Interval 0.00073 to 0.00145
Apparent Diffusion Coefficient Before, During, and After Chemoradiotherapy Week 2 CRT	0.00110 mm2/s Interval 0.00092 to 0.00136
Apparent Diffusion Coefficient Before, During, and After Chemoradiotherapy Week 3 CRT	0.00118 mm2/s Interval 0.0009 to 0.00156
Apparent Diffusion Coefficient Before, During, and After Chemoradiotherapy Week 4 CRT	0.00122 mm2/s Interval 0.00097 to 0.00154
Apparent Diffusion Coefficient Before, During, and After Chemoradiotherapy Week 5 CRT	0.00125 mm2/s Interval 0.00103 to 0.00158
Apparent Diffusion Coefficient Before, During, and After Chemoradiotherapy Week 6 CRT	0.00125 mm2/s Interval 0.00098 to 0.00154
Apparent Diffusion Coefficient Before, During, and After Chemoradiotherapy Pre-C1 TMZ	0.00132 mm2/s Interval 0.00107 to 0.00173
Apparent Diffusion Coefficient Before, During, and After Chemoradiotherapy Pre-C4 TMZ	0.00133 mm2/s Interval 0.00112 to 0.00151
Apparent Diffusion Coefficient Before, During, and After Chemoradiotherapy Pre-C5 TMZ	0.00148 mm2/s Interval 0.00069 to 0.00257
Apparent Diffusion Coefficient Before, During, and After Chemoradiotherapy Post-TMZ	0.00140 mm2/s Interval 0.00005 to 0.00275
Apparent Diffusion Coefficient Before, During, and After Chemoradiotherapy Baseline 1	0.00110 mm2/s Interval 0.00078 to 0.00169
Apparent Diffusion Coefficient Before, During, and After Chemoradiotherapy Pre-C2 TMZ	0.00127 mm2/s Interval 0.00101 to 0.00155
Apparent Diffusion Coefficient Before, During, and After Chemoradiotherapy Pre-C3 TMZ	0.00108 mm2/s Interval 0.00043 to 0.00128
Apparent Diffusion Coefficient Before, During, and After Chemoradiotherapy Pre-C6 TMZ	0.00179 mm2/s Interval 0.0014 to 0.00258

PRIMARY outcome

Timeframe: Baseline, weekly during treatment, monthly following treatment for up to six months

Population: Data not collected

Fractional anisotropy (FA) is a measure of the directionality of the molecular motion of water.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, weekly during treatment, monthly following treatment for up to six months

Population: Data not collected

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, weekly during treatment, monthly following treatment for up to six months

Population: Data not collected

Outcome measures

Outcome data not reported

Adverse Events

Temozolomide and Radiation Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Elizabeth Gerstner

Massachusetts General Hospital

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place