NCT02367469

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 12, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 20, 2015

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 5, 2022

Status Verified

January 1, 2022

Enrollment Period

7.9 years

First QC Date

February 12, 2015

Last Update Submit

January 4, 2022

Conditions

Brain Tumors

Keywords

recurrent brain tumorsbrain tumorsNewly diagnosed brain tumors

Outcome Measures

Primary Outcomes (2)

  • In newly diagnosed tumors

    Diagnostic accuracy of AMT-PET to differentiate brain tumor types and detect tumor infiltration of the brain.

    single time-point

  • In previously treated tumors

    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 Outcomes (1)

  • Tryptophan metabolism

    single time-point

Study Arms (1)

Brain Tumors

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

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.
  • Age ≥13 years.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayne State University

Detroit, Michigan, 48201, United States

Location

Related Publications (9)

  • Jeong JW, Lee MH, John F, Robinette NL, Amit-Yousif AJ, Barger GR, Mittal S, Juhasz C. Feasibility of Multimodal MRI-Based Deep Learning Prediction of High Amino Acid Uptake Regions and Survival in Patients With Glioblastoma. Front Neurol. 2019 Dec 17;10:1305. doi: 10.3389/fneur.2019.01305. eCollection 2019.

    PMID: 31920928RESULT

  • John F, Robinette NL, Amit-Yousif AJ, Bosnyak E, Barger GR, Shah KD, Mittal S, Juhasz C. Multimodal Imaging of Nonenhancing Glioblastoma Regions. Mol Imaging. 2019 Jan-Dec;18:1536012119885222. doi: 10.1177/1536012119885222.

    PMID: 31736437RESULT

  • John F, Bosnyak E, Robinette NL, Amit-Yousif AJ, Barger GR, Shah KD, Michelhaugh SK, Klinger NV, Mittal S, Juhasz C. Multimodal imaging-defined subregions in newly diagnosed glioblastoma: impact on overall survival. Neuro Oncol. 2019 Feb 14;21(2):264-273. doi: 10.1093/neuonc/noy169.

    PMID: 30346623RESULT

  • Guastella AR, Michelhaugh SK, Klinger NV, Fadel HA, Kiousis S, Ali-Fehmi R, Kupsky WJ, Juhasz C, Mittal S. Investigation of the aryl hydrocarbon receptor and the intrinsic tumoral component of the kynurenine pathway of tryptophan metabolism in primary brain tumors. J Neurooncol. 2018 Sep;139(2):239-249. doi: 10.1007/s11060-018-2869-6. Epub 2018 Apr 17.

    PMID: 29667084RESULT

  • Bosnyak E, Michelhaugh SK, Klinger NV, Kamson DO, Barger GR, Mittal S, Juhasz C. Prognostic Molecular and Imaging Biomarkers in Primary Glioblastoma. Clin Nucl Med. 2017 May;42(5):341-347. doi: 10.1097/RLU.0000000000001577.

    PMID: 28195901RESULT

  • Bosnyak E, Kamson DO, Robinette NL, Barger GR, Mittal S, Juhasz C. Tryptophan PET predicts spatial and temporal patterns of post-treatment glioblastoma progression detected by contrast-enhanced MRI. J Neurooncol. 2016 Jan;126(2):317-25. doi: 10.1007/s11060-015-1970-3. Epub 2015 Oct 29.

    PMID: 26514361RESULT

  • Bosnyak E, Kamson DO, Behen ME, Barger GR, Mittal S, Juhasz C. Imaging cerebral tryptophan metabolism in brain tumor-associated depression. EJNMMI Res. 2015 Dec;5(1):56. doi: 10.1186/s13550-015-0136-9. Epub 2015 Oct 17.

    PMID: 26475140RESULT

  • Jeong JW, Juhasz C, Mittal S, Bosnyak E, Kamson DO, Barger GR, Robinette NL, Kupsky WJ, Chugani DC. Multi-modal imaging of tumor cellularity and Tryptophan metabolism in human Gliomas. Cancer Imaging. 2015 Aug 6;15(1):10. doi: 10.1186/s40644-015-0045-1.

    PMID: 26245742RESULT

  • John F, Michelhaugh SK, Barger GR, Mittal S, Juhasz C. Depression and tryptophan metabolism in patients with primary brain tumors: Clinical and molecular imaging correlates. Brain Imaging Behav. 2021 Apr;15(2):974-985. doi: 10.1007/s11682-020-00305-7.

    PMID: 32767048RESULT

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.

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Csaba Juhasz

    Wayne State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 12, 2015

First Posted

February 20, 2015

Study Start

February 1, 2014

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 5, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)