Discerning Pseudoprogression vs True Tumor Growth in GBMs

NCT02905643 | Terminated

• 1 other identifier: R20150109
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glioblastoma

Keywords

Pseudoprogression; Brain Cancer

Outcome Measures

Primary Outcomes (1)

• Imaging parameter utility for pseudoprogression vs. true tumor growth

  The primary outcome of this study is to assess the utility of peak height, peak signal recovery, apparent diffusion coefficient, and cerebral blood volume (and their relative values) in determining, positive predictive values (PPV), negative predictive values (NPV), and likelihood ratios (LR) for identifying pseudo progression versus true tumor growth.

  Up to 24 months

Study Arms (1)

Study subjects

Patients who have or might have a brain tumor which may be a glioblastoma.

Other: Study subjects

Interventions

Study subjects OTHER

This study does not include an intervention it is only observational.

Study subjects

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who have or might have a brain tumor which may be a glioblastoma.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ascension Health: lead

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Eric Beltz, MD

  Northwest Radiology Network, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 19, 2016
• Study Start: September 1, 2016
• Primary Completion: February 13, 2018
• Study Completion: February 13, 2018
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share