Trial Outcomes & Findings for Accurate DCE-MRI Measurement of Glioblastoma Using Point-of-care Portable Perfusion Phantom (NCT NCT05140902)

Last Updated: 2025-02-14

Results Overview

The goal is to measure the reproducibility of blood perfusion measurement in the glioblastoma using the two consecutive DCE-MRI scans with and without P4-based error correction. The pharmacokinetic (PK) parameter within the region of interest (ROI) will be averaged at each scan after P4-based error correction, and the mean values of two scans will be compared to calculate the coefficient of variation (%COV).

Recruitment status

COMPLETED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

At the end of Cycle 2 of chemoradiation therapy (each cycle is 28 days)

Results posted on

2025-02-14

Participant Flow

Participant milestones

Participant milestones
Measure	Glioblastoma Patients glioblastoma patients with newly or enlarged enhancing lesion within 3 months after completing 6 weeks of adjuvant chemoradiation therapy Point-of-care Portable Perfusion Phantom (P4): P4 is a perfusion phantom developed by Dr. Harrison Kim that can significantly reduce variation in quantitating perfusion of human abdominal tissues across MRI scanners.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Accurate DCE-MRI Measurement of Glioblastoma Using Point-of-care Portable Perfusion Phantom

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Glioblastoma Patients n=12 Participants glioblastoma patients with newly or enlarged enhancing lesion within 3 months after completing 6 weeks of adjuvant chemoradiation therapy Point-of-care Portable Perfusion Phantom (P4): P4 is a perfusion phantom developed by Dr. Harrison Kim that can significantly reduce variation in quantitating perfusion of human abdominal tissues across MRI scanners.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 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	0 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	12 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	12 participants n=5 Participants

PRIMARY outcome

Timeframe: At the end of Cycle 2 of chemoradiation therapy (each cycle is 28 days)

Outcome measures

Outcome measures
Measure	Glioblastoma Patients n=12 Participants glioblastoma patients with newly or enlarged enhancing lesion within 3 months after completing 6 weeks of adjuvant chemoradiation therapy Point-of-care Portable Perfusion Phantom (P4): P4 is a perfusion phantom developed by Dr. Harrison Kim that can significantly reduce variation in quantitating perfusion of human abdominal tissues across MRI scanners.
To Measure the Reproducibility of qDCE-MRI Measurement of Glioblastoma.	5 %COV

PRIMARY outcome

Timeframe: At the end of Cycle 2 of chemoradiation therapy (each cycle is 28 days)

The PK parameter (e.g., Ktrans) in the tumor with pseudoprogression will be statistically compared with that with true-progression before and after P4-based error correction to determine whether the differentiation between the pseudo- and true-progressions of glioblastoma can be improved using qDCE-MRI after P4-based error correction. Each tumor will be classified into pseudo- or true-progression based on RANO criteria.

Outcome measures

Outcome measures
Measure	Glioblastoma Patients n=12 Participants glioblastoma patients with newly or enlarged enhancing lesion within 3 months after completing 6 weeks of adjuvant chemoradiation therapy Point-of-care Portable Perfusion Phantom (P4): P4 is a perfusion phantom developed by Dr. Harrison Kim that can significantly reduce variation in quantitating perfusion of human abdominal tissues across MRI scanners.
The Differentiation Between the Pseudo- and True-progressions of Glioblastoma Can be Improved Using qDCE-MRI After P4-based Error Correction.	100 Accuracy (%)

Adverse Events

Glioblastoma Patients

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. Harrison Kim

University of Alabama at Birmingham

Phone: 205-996-4088

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place