Trial Outcomes & Findings for Assessing 11C-Choline (11C-CH) PET to Distinguish True Tumor Progression From Pseudoprogression in High-grade Gliomas (NCT NCT02849171)

Last Updated: 2022-12-29

Results Overview

from 11C-CH PET with evolving changes on brain MRI in high-grade glioma after radiotherapy. In a small subgroup of patients required surgery, tissue will be analyzed for histopathologic correlate. The data gathered will not be considered definitive, but rather will be used to as preliminary data in support of a larger, definitive study.

Recruitment status

COMPLETED

Study phase

Target enrollment

8 participants

Primary outcome timeframe

1 year

Results posted on

2022-12-29

Participant Flow

All participants have the same disease type, so they were assigned to a single study cohort

Participant milestones

Participant milestones
Measure	High-grade Glioma Eligible patients must have undergone standard radiation (typically 60Gy in 30 fractions), with or without concurrent drug therapy, and have MRI findings consistent with tumor progression and/or pseudoprogression within 24 weeks after completion of radiation. Eligible patients will undergo an 11C-CH PET study within 2 weeks of the standard of care MRI that shows changes concerning for tumor progression vs. pseudoprogression. All patients will then be followed with surveillance brain MRI with and without contrast as per standard of care for a period of 11 months, to assess further progression or stabilization of the lesion. Initial MRI changes are considered to represent pseudoprogression/treatment related changes if the lesion stabilizes or becomes smaller without a change in tumor-related therapy. Otherwise, it will be considered a recurrence should there be progessive radiographic changes. PET scan C-Choline
Overall Study STARTED	8
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	High-grade Glioma Eligible patients must have undergone standard radiation (typically 60Gy in 30 fractions), with or without concurrent drug therapy, and have MRI findings consistent with tumor progression and/or pseudoprogression within 24 weeks after completion of radiation. Eligible patients will undergo an 11C-CH PET study within 2 weeks of the standard of care MRI that shows changes concerning for tumor progression vs. pseudoprogression. All patients will then be followed with surveillance brain MRI with and without contrast as per standard of care for a period of 11 months, to assess further progression or stabilization of the lesion. Initial MRI changes are considered to represent pseudoprogression/treatment related changes if the lesion stabilizes or becomes smaller without a change in tumor-related therapy. Otherwise, it will be considered a recurrence should there be progessive radiographic changes. PET scan C-Choline
Overall Study Withdrawal by Subject	1
Overall Study Not treated	1

Baseline Characteristics

Assessing 11C-Choline (11C-CH) PET to Distinguish True Tumor Progression From Pseudoprogression in High-grade Gliomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High-grade Glioma n=8 Participants All participants have the same disease type, so they were assigned to a single study cohort
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: N/A - Data were not collected

Outcome measures

Outcome data not reported

Adverse Events

High-grade Glioma

Serious events: 0 serious events

Other events: 6 other events

Deaths: 7 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	High-grade Glioma n=8 participants at risk All participants have the same disease type, so they were assigned to a single study cohort
Metabolism and nutrition disorders Hyperglycemia	75.0% 6/8 • 1 year
Investigations Lymphocyte count decreased	62.5% 5/8 • 1 year
Blood and lymphatic system disorders Anemia	50.0% 4/8 • 1 year
Metabolism and nutrition disorders Hypoalbuminemia	50.0% 4/8 • 1 year
Investigations Platelet count decreased	50.0% 4/8 • 1 year
Investigations White blood cell decreased	50.0% 4/8 • 1 year
Metabolism and nutrition disorders Hypokalemia	12.5% 1/8 • 1 year
Metabolism and nutrition disorders Hyponatremia	12.5% 1/8 • 1 year
Metabolism and nutrition disorders Hypocalcemia	12.5% 1/8 • 1 year
Investigations Neutrophil count decreased	12.5% 1/8 • 1 year

Additional Information

Ronald Blasberg, MD

Memorial Sloan Kettering Cancer Center

Phone: 646-888-2211

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place