Tryptophan Metabolism in Human Brain Tumors

January 4, 2022 updated by: Csaba Juhasz, Wayne State University
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with newly diagnosed or recurrent brain tumors will be studied.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
single time-point
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.
single time-point

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tryptophan metabolism
Time Frame: single time-point
To evaluate activity of the kynurenine pathway of tryptophan metabolism in resected tumor tissues.
single time-point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wayne State University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Csaba Juhasz, Wayne State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

February 12, 2015

First Submitted That Met QC Criteria

February 19, 2015

First Posted (Estimate)

February 20, 2015

Study Record Updates

Last Update Posted (Actual)

January 5, 2022

Last Update Submitted That Met QC Criteria

January 4, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI Tryptophan
  • CA123451 (Other Grant/Funding Number: NCI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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