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Discerning Pseudoprogression vs True Tumor Growth in GBMs

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

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.

 Observational
Eligible Ages 18 Years - 99 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

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.

 NCT02905643
Phase

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.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Ascension Health
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Eric Beltz, MD
Principal Investigator Affiliation Northwest Radiology Network, Inc
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Terminated
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Additional Details

See BRIEF SUMMARY section

Arms & Interventions

Arms

: Study subjects

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

Interventions

Other: - Study subjects

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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