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Metabolic Tumor Volumes in Radiation Treatment of Primary Brain Tumors

Study Purpose

  • - Metabolic Tumor Volume (MTV), identified by Magnetic Resonance Spectroscopic Imaging (MRSI) is different from the Clinical Target Volume (CTV) used for radiation dose delivery in the treatment of brain tumors.
  • - If MTV > CTV, the investigators hypothesize that the difference in volumes (cc) is related to worse clinical outcome.
Furthermore, in case of local recurrence, the lesion is located in the MTV area that is outside of the CTV.
  • - Alternatively, if CTV > MTV, then the difference in volumes is related to higher treatment toxicity.

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 and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients must have histologically confirmed primary brain tumor.
  • - Patients may be enrolled prior to surgery, after surgical resection or with unresectable tumors.
  • - Patients must be 18 years or older.
  • - Patients who do not have metal in the body (e.g. pacemakers, implants) that would preclude them from undergoing MRI/MRS exam.
  • - Patients who do not suffer from claustrophobia (fear of enclosed spaces) - Karnofsky performance status ≥ 60.
  • - Patients whose size would allow them to fit into the bore of the MRI instrument.
  • - Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • - Patients younger than 18 years.
  • - Inability to undergo MRI/MRS exam because of metal in the head or body, such as implants, pacemaker, or biostimulation device.
Claustrophobia (fear of enclosed spaces).
  • - Karnofsky performance status < 60.
  • - Patients too large (> 300 lbs.
) to fit into the bore of the MRI instrument.
  • - Inability to understand the informed consent document.

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.

 NCT02006563
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 Miami
Principal Investigator

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

 Radka Stoyanova, PhD
Principal Investigator Affiliation University of Miami
Agency Class

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

 Other
Overall Status Completed
Countries United States
Conditions

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

 Brain Tumor, Glioblastoma Multiforme
Additional Details

Metabolic Tumor Volume (MTV), identified by Magnetic Resonance Spectroscopic Imaging (MRSI) is different from the Clinical Target Volume (CTV) used for radiation dose delivery in the treatment of brain tumors.

  • - If MTV > CTV, the investigators hypothesize that the difference in volumes (cc) is related to worse clinical outcome.
Furthermore, in case of local recurrence, the lesion is located in the MTV area that is outside of the CTV.
  • - Alternatively, if CTV > MTV, then the difference in volumes is related to higher treatment toxicity.

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.

University of Miami, Miami, Florida

Status

Address

University of Miami

Miami, Florida, 33136

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