Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
Inclusion Criteria:1. Adult patients (age 18 years or older). 2. Patients treated with surgery, followed by chemoradiation therapy, and currently under chemotherapy. 3. Patients with a newly or enlarged enhancing lesion inside the radiation field at least three months after completion of radiation therapy. 4. Patients with signed informed consent.
Exclusion Criteria:1. Participants with safety contraindications to MRI examination (determined by standard clinical screening). 2. Participants on hemodialysis or with acute renal failure. 3. Participants who are pregnant, lactating or are planning to become pregnant during the study. 4. Participants who are planning to farther a child during the study.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of Alabama at Birmingham|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Harrison Kim, PhD|
|Principal Investigator Affiliation||University of Alabama at Birmingham|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Glioblastoma is the most common primary malignant type of brain tumor in adults. Surgical tumor resection followed by chemoradiation therapy is the standard of care for patients with glioblastoma, but its prognosis is still fairly dismal (median survival time = 15 months). One major concern that prevents effective treatment management is the difficulty of differentiating between pseudo-progression and true-progression. Pseudo-progression occurs in about 20-30% of glioblastoma patients typically within 3 months after chemoradiation therapy has been completed. Pseudo-progression is a local inflammatory reaction caused by irradiation and enhanced by concurrent chemotherapy, which leads to a transient increase of blood brain barrier (BBB) permeability. The BBB, however, is also disrupted by new cancer occurrence. Therefore, both pseudo- and true-progressions appear with an increased contrast enhancement in MRI, and there are currently no established techniques to differentiate between them. Pseudo-progression is typically known to be associated with better clinical outcomes, so pseudo-progression mistaken for true-progression results in the discontinuation of an effective therapy, while true-progression mistaken for pseudo-progression leads to the continuation of an ineffective therapy that may induce adverse side effects. DCE-MRI has potential to differentiate between pseudo- and true-progressions of glioblastoma. The enhancing lesions of pseudo-progression are due to inflammation, whereas those of true-progression are caused by cancer growing. Thus, true-progression typically presents higher perfusion than pseudo-progression does. DCE-MRI can quantitatively assess the tissue perfusion by monitoring the dynamic change of MRI contrast agent concentration. Several investigators have demonstrated the potential of quantitative DCE-MRI to differentiate between pseudo- and true-progressions. However, the variability in quantitative DCE-MRI measurement across different MRI scanners remains a major concern, as it hinders data comparison among institutes to retrieve a reliable threshold for accurate prognosis and subsequent treatment optimization. A point-of-care perfusion phantom may allow high reproducibility and accurate comparison of quantitative DCE-MRI data across MRI platforms. The UAB radiological research team recently developed the P4 phantom, which is small enough to be imaged concurrently with a patient for real-time quality assurance, but large enough not to suffer from the partial volume effect. The P4 phantom creates constant contrast enhancement curves with very robust repeatability, and thus the contrast agent concentration time-course in a tumor, which is a major source of error in quantitating DCE-MRI parameters, can be accurately calculated in reference to the values observed in the phantom. In our previous study, the variability in quantitating the volume transfer constant of various human tissues across two different MRI scanners was reduced fivefold after P4-based error correction. The investigators hypothesize that the variability in quantitative DCE-MRI measurement of glioblastoma across different scanners will be significantly reduced when the P4 is used for error correction, leading to better differentiation between pseudo- and true-progressions. The goal of this study is to test this hypothesis.
Experimental: Glioblastoma patients
glioblastoma patients with newly or enlarged enhancing lesion within 3 months after completing 6 weeks of adjuvant chemoradiation therapy
Device: - 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.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.