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Advanced Perfusion MRI of Treatment Response and Progression in Glioblastoma

Study Purpose

The primary aim of this project is to Compare new msCS and standard DSC-PWI methods in GBM patients undergoing post-operative MRI for monitoring of tumor progression.

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 - 82 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Histology: Glioblastoma (grade 4 astrocytoma) - Standard-of-care, post-gd T1w image changes suggestive or consistent with of progression.
  • - Standard-of-care MRI included conventional DSC-PWI without unexpected technical difficulties.
  • - Methylation status of tumor available in medical record.
  • - Able to provide written informed consent.

Exclusion Criteria:

  • - Contraindications either to 3T MRI (e.g. certain metallic and electronic implants, claustrophobia) or IV gadolinium contrast (allergy, pregnancy, breast-feeding, renal insufficiency).
Screening for these contraindications will be based on history only (as it is for all routine outpatient clinical MRI at UWHC).
  • - Significant physical or mental disease which would preclude successful compliance and participation in the study or, in the opinion of the principal investigator, or co-investigator, constitute a hazard, such that enrollment in the study would not be in the patient's best interest.
  • - Special subjects such as minors, mentally disabled persons, or prisoners.

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.

NCT02769806
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.

University of Wisconsin, Madison
Principal Investigator

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

Alexey Samsonov
Principal Investigator Affiliation University of Wisconsin, Madison
Agency Class

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

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

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

Glioblastoma, Glioblastoma Multiforme
Study Website: View Trial Website
Additional Details

Investigators will compare the novel to the standard DSC-PWI methods in twenty five GBM patients to determine whether novel method improves image quality in tumor regions. We will also compare accuracy of pseudoprogression (PsP) vs.#46; early progressive disease (ePD) determinations by the two techniques. If successful, the project will culminate in a novel imaging method sequence optimized to monitor progression and guide treatment decisions in post-operative GBM patients.

Arms & Interventions

Arms

: GBM patients undergoing MRI

GBM patients undergoing standard-of-care post-operative combination chemoRT and clinically indicated MRI including standard DSC-PWI for follow-up.

Interventions

Procedure: - MRI

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.

Madison, Wisconsin

Status

Recruiting

Address

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792

Site Contact

Cancer Connect

clinicaltrials@cancer.wisc.edu

800-622-8922