Trial Outcomes & Findings for A Comparison of MRI Perfusion and FDG PET/CT to Distinguish Between Radiation Injury and Tumor Progression (NCT NCT01604512)
NCT ID: NCT01604512
Last Updated: 2025-04-08
Results Overview
To assess the utility of PET/CT and MRI perfusion studies in predicting whether worsening enhancing brain lesions seen after radiation therapy represent radiation injury or tumor progression. This study will examine the role of these two imaging techniques in predicting diagnosis and treatment planning.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
148 participants
Primary outcome timeframe
2 years
Results posted on
2025-04-08
Participant Flow
Participant milestones
| Measure |
Pts With a Brain Tumor
The study will prospectively enroll patients who have increasing size and/or enhancement of brain lesion(s) after brain radiation therapy for a neoplasm (either primary or metastatic), where. it is unclear if a lesion represents radiation injury or progressive tumor. At the discretion of PI the RSI sequence may be repeated at SOC FDG or other radiotracer imaging carried out while the patient is still on study, if deemed clinically necessary.
|
|---|---|
|
Overall Study
STARTED
|
148
|
|
Overall Study
COMPLETED
|
141
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Pts With a Brain Tumor
The study will prospectively enroll patients who have increasing size and/or enhancement of brain lesion(s) after brain radiation therapy for a neoplasm (either primary or metastatic), where. it is unclear if a lesion represents radiation injury or progressive tumor. At the discretion of PI the RSI sequence may be repeated at SOC FDG or other radiotracer imaging carried out while the patient is still on study, if deemed clinically necessary.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Not treated
|
4
|
Baseline Characteristics
A Comparison of MRI Perfusion and FDG PET/CT to Distinguish Between Radiation Injury and Tumor Progression
Baseline characteristics by cohort
| Measure |
Pts With a Brain Tumor
n=148 Participants
The study will prospectively enroll patients who have increasing size and/or enhancement of brain lesion(s) after brain radiation therapy for a neoplasm (either primary or metastatic), where. it is unclear if a lesion represents radiation injury or progressive tumor. At the discretion of PI the RSI sequence may be repeated at SOC FDG or other radiotracer imaging carried out while the patient is still on study, if deemed clinically necessary.
|
|---|---|
|
Age, Continuous
|
56 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
69 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
124 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
148 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 2 yearsTo assess the utility of PET/CT and MRI perfusion studies in predicting whether worsening enhancing brain lesions seen after radiation therapy represent radiation injury or tumor progression. This study will examine the role of these two imaging techniques in predicting diagnosis and treatment planning.
Outcome measures
| Measure |
Pts With a Brain Tumor
n=148 Participants
The study will prospectively enroll patients who have increasing size and/or enhancement of brain lesion(s) after brain radiation therapy for a neoplasm (either primary or metastatic), where. it is unclear if a lesion represents radiation injury or progressive tumor. At the discretion of PI the RSI sequence may be repeated at SOC FDG or other radiotracer imaging carried out while the patient is still on study, if deemed clinically necessary.
|
|---|---|
|
Number of Participants Who Received PET/CT and MRI Perfusion Studies
Participants who received PET/CT and MRI perfusion studies
|
53 Participants
|
|
Number of Participants Who Received PET/CT and MRI Perfusion Studies
Participants who did not receive PET/CT and MRI perfusion studies
|
95 Participants
|
SECONDARY outcome
Timeframe: up to 99 monthsMedian time between Radiation Therapy and detection of indeterminate lesion
Outcome measures
| Measure |
Pts With a Brain Tumor
n=148 Participants
The study will prospectively enroll patients who have increasing size and/or enhancement of brain lesion(s) after brain radiation therapy for a neoplasm (either primary or metastatic), where. it is unclear if a lesion represents radiation injury or progressive tumor. At the discretion of PI the RSI sequence may be repeated at SOC FDG or other radiotracer imaging carried out while the patient is still on study, if deemed clinically necessary.
|
|---|---|
|
Median Time Between Radiation Therapy and Detection of Indeterminate Lesion
|
9 months
Interval 1.0 to 99.0
|
Adverse Events
Pts With a Brain Tumor
Serious events: 6 serious events
Other events: 0 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Pts With a Brain Tumor
n=148 participants at risk
The study will prospectively enroll patients who have increasing size and/or enhancement of brain lesion(s) after brain radiation therapy for a neoplasm (either primary or metastatic), where. it is unclear if a lesion represents radiation injury or progressive tumor. At the discretion of PI the RSI sequence may be repeated at SOC FDG or other radiotracer imaging carried out while the patient is still on study, if deemed clinically necessary.
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|---|---|
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General disorders
Death NOS
|
3.4%
5/148 • 2 years
|
|
Nervous system disorders
Seizure
|
0.68%
1/148 • 2 years
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Robert Young, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-8196
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place