Clinical trial NCT02905643: Discerning Pseudoprogression vs True Tumor Growth in GBMs
Official title: The Use of Peak Height and Percentage Signal Recovery for Evaluation and Determination of Pseudoprogression in Glioblastoma Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Glioblastoma
Keywords: Pseudoprogression
Brain Cancer
Lead sponsor: Ascension Health
Sponsor class: INDUSTRY
First posted: 2016-09-19
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who have or might have a brain tumor which may be a glioblastoma.

Brief summary: One-third of all primary brain tumors are astrocytomas, the most common type of glioma. Grade 4 astrocytomas, more commonly known as glioblastomas (GBMs), represent about 50% of all gliomas (annual incidence of over 3 per 100,000) and are associated with high mortality rates and median patient survival of just 12-15 months post-diagnosis. Treatment response is assessed by measuring post-treatment tumor size on contrast-enhanced magnetic resonance images (MRI). However, radiation and chemotherapy cause inflammatory and necrotic changes which, like actual tumor progression itself, demonstrate contrast enhancement on the first post-treatment MRI scan. This enhancement eventually subsides (typically within 6 months of treatment) and is known as pseudoprogression (PsP). Currently, there is no gold standard noninvasive tool for distinguishing between pseudoprogression and progressive disease. Dynamic susceptibility-weighted contrast-enhanced perfusion MRI (DSC perfusion MRI) permits measurement of hemodynamic imaging variables. Previous literature reports attempted to use some or all of these metrics to assess their utility in distinguishing PsP from true cancer progression. These studies showed mixed results, likely due to a number of factors, including poor statistical power, poorly defined PsP, analysis of multiple cancer grades and types, and varied analysis methodologies. The investigators aim to address these issues in this study.

Detailed description: See BRIEF SUMMARY section

Eligibility criteria: Inclusion Criteria:

* Participants must be 18 years of age or older.
* Participants must be able to read and comprehend the English language.
* In agreement with the care providing physician, participants must be willing to have surgery to remove possible brain tumor.
* Participants must have a MRI scan within 24 hours after the tumor is removed (if a tumor is confirmed).
* Participants must have the tumor analyzed by the laboratory and pathology departments and receive the diagnosis of glioblastoma.
* Participants must be willing to follow the Stupp treatment protocol (this treatment plan and its' procedures are considered the standard for treating glioblastoma). (The Stupp protocol is the name of the radiation and chemotherapy plan that has been found to help in many cases of glioblastoma.)
* Participants must be willing to follow any additional study procedures (including having all follow-up MRIs performed at St. Vincent 86th St).

Exclusion Criteria:

* Participants are less than 18 years of age.
* Participants have had surgery for your brain tumor and NOT received the diagnosis of glioblastoma
* Participants and care providing physician have decided NOT to follow the Stupp protocol (treatment plan) for glioblastoma treatment. (Deviations or interruptions are allowed if clinically indicated)
* Participants are not having a MRI scan within 24 hours after brain tumor surgery.
* Participants are not willing to follow the study procedures.

Primary outcomes:
measure: Imaging parameter utility for pseudoprogression vs. true tumor growth
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Northwest Radiology Network, Inc
name: Eric Beltz, MD
role: PRINCIPAL_INVESTIGATOR
References: