Tryptophan Metabolism in Human Brain Tumors
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|ClinicalTrials.gov Identifier: NCT02367469|
Recruitment Status : Recruiting
First Posted : February 20, 2015
Last Update Posted : May 2, 2019
|Condition or disease|
If you agree to take part in this research study, you will be asked to have:
1. a PET scan, 2. brief clinical questionnaires, and 3. biochemical studies of blood and tumor tissue. You may also have a second PET scan later, if you undergo therapy (such as surgery and/or brain radiation), to determine if there are PET signs of tumor. Your ability to participate in the study will be based, in part, on the results of the magnetic resonance images (MRI) in your medical chart from earlier clinical procedures. Once we receive the results of the PET scan, these will be compared to the MRI in order to help us analyze whether the tryptophan uptake tells us anything about the type of tumor in your brain. It will take about 3 hours to complete the PET scan; this includes the completion of the questionnaires, preparation and scanning. The actual scanning time will be 70 minutes. If you are a female of child-bearing age, we will need a small urine sample from you before starting the PET scanning procedure to make absolutely sure that you do not have unknown pregnancy for which radiation exposure might be harmful.
- The PET scan will be used to measure the accumulation of the injected radioactive tracer AMT in your brain. To make this measurement more accurate, we will use your clinically obtained MRI scan(s), which was used to diagnose the tumor, to identify the exact location and extent of the tumor. For the PET scan, an intravenous catheter (a small tube placed in your vein) will be inserted for the injection of the AMT for this PET scan. It is the tracer that the PET scanner "sees" when performing the scan. The amount of the tracer, which will be given is very small (5 ml, the volume of a teaspoon), and therefore no side effects are expected from the tracer itself. A second intravenous catheter will be inserted to collect blood samples during the scan; a total of less than 2 teaspoons of blood will be collected. Participants may be sedated (put into sleep with some medicine) if they are unable to remain still for the scanning period.
- On the day of the PET scan, we will ask you to fill out a brief clinical questionnaire, and also an additional multiple-choice questionnaire to screen for potential mood problems (which often coincide with brain tumors). Participants with a potential speech (comprehension) problem will also be administered a brief speech test. The goal of these tests is to identify various clinical problems that can be associated with brain tumors and affected by abnormal tryptophan metabolism that we measure with the PET scan.
- If you have surgery to remove the tumor, a portion of the removed tissue will be used for biochemical studies. The doctor will not remove more tissue than needed for your care. The blood (obtained during the PET scanning) and tumor tissue (obtained during surgery) will be processed for analysis and stored in a locked container or freezer in a laboratory. In addition, we will review the clinical pathology report, so that we can correlate your PET results to type and grade of the tumor.
|Study Type :||Observational|
|Estimated Enrollment :||105 participants|
|Official Title:||Tryptophan Metabolism in Human Brain Tumors|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Patients with newly diagnosed or recurrent brain tumors will be studied.
- In newly diagnosed tumors [ Time Frame: single time-point ]Diagnostic accuracy of AMT-PET to differentiate brain tumor types and detect tumor infiltration of the brain.
- In previously treated tumors [ Time Frame: single time-point ]Accuracy of AMT-PET to predict post-treatment progression and differentiate recurrent tumors from radiation-induced changes, as compared to clinical MRI.
- Tryptophan metabolism [ Time Frame: single time-point ]To evaluate activity of the kynurenine pathway of tryptophan metabolism in resected tumor tissues.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02367469
|Contact: Lynda Ferguson||313-993-0006||LFerguso2@dmc.org|
|Contact: Erica Harrisfirstname.lastname@example.org|
|United States, Michigan|
|Wayne State University||Recruiting|
|Detroit, Michigan, United States, 48201|
|Contact: Lynda Ferguson 313-993-0006 email@example.com|
|Contact: Erica Harris 313-966-7218 firstname.lastname@example.org|
|Principal Investigator: Csaba Juhasz, MD, PhD|
|Sub-Investigator: Sandeep Mittal, MD|
|Principal Investigator:||Csaba Juhasz||Wayne State University|