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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Csaba Juhasz MD, PhD, Wayne State University

Brief Summary:
The main purpose of this study is to determine the potential clinical utility of PET imaging using the radiotracer [C-11]alpha-methyl-L-tryptophan in the diagnosis, differentiation and monitoring of various brain tumors, both before and after initial treatment. We will also study mechanisms and clinical significance of abnormal brain tumor tryptophan metabolism using resected tumor tissues.

Condition or disease
Brain Tumors

Detailed Description:

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.

  1. 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.
  2. 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.
  3. 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.

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Study Type : Observational
Estimated Enrollment : 105 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors
Drug Information available for: Tryptophan

Group/Cohort
Brain Tumors
Patients with newly diagnosed or recurrent brain tumors will be studied.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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
We will collect and analyze tumor specimens obtained after AMT-PET during tumor resection (if not used for routine histopathology). Various histopathologic features will be studied, e.g., tumor proliferative activity, expression of amino acid transporter as well as enzymes and metabolites of the kynurenine pathway, and these will also be correlated with neuroimaging findings.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with newly diagnosed or recurrent brain tumors will be studied.
Criteria

Inclusion Criteria:

  1. Clinical and MRI diagnosis of an intracranial lesion suspicious for a brain tumor, including primary and metastatic tumors, or a possible residual or recurrent brain tumor (based on clinical imaging); or history of glioma treatment with chemoradiation, even if no definite progression is found on clinical MRI.
  2. Age ≥13 years.

Exclusion Criteria:

  1. Severe increased intracranial pressure, status epilepticus, or other symptoms requiring emergency or urgent intervention.
  2. Resective surgery within 2 months prior to the PET scan (acute/subacute post-surgical inflammatory changes may cause false positive increases on AMT PET).
  3. Positive pregnancy test (because of radiation involved in PET scanning).

Information from the National Library of Medicine

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


Contacts
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Contact: Lynda Ferguson 313-993-0006 LFerguso2@dmc.org
Contact: Erica Harris 313-966-7218 eharri@med.wayne.edu

Locations
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United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Lynda Ferguson    313-993-0006    lferguson2@dmc.org   
Contact: Erica Harris    313-966-7218    eharri@med.wayne.edu   
Principal Investigator: Csaba Juhasz, MD, PhD         
Sub-Investigator: Sandeep Mittal, MD         
Sponsors and Collaborators
Wayne State University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Csaba Juhasz Wayne State University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Csaba Juhasz MD, PhD, Principal Investigator, Wayne State University
ClinicalTrials.gov Identifier: NCT02367469     History of Changes
Other Study ID Numbers: NCI Tryptophan
CA123451 ( Other Grant/Funding Number: NCI )
First Posted: February 20, 2015    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Csaba Juhasz MD, PhD, Wayne State University:
recurrent brain tumors
brain tumors
Newly diagnosed brain tumors

Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tryptophan
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs