11C-Methionine PET as Prognostic Marker of Gliomas

Overview

This is a retrospective study that involves the revision of clinical, instrumental and pathologic data of an estimated cohort of maximum 145 patients with glioma treated with surgery with radical intent at our center.

Full Title of Study: “Role of 11C-Methionine PET for the Prognostic and Molecular Characterization of Gliomas Candidate to Surgery.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: December 31, 2018

Detailed Description

This is a retrospective observation that involves the revision of clinical, instrumental and pathologic data of an estimated cohort of 145 patients with glioma treated with surgery with radical intent at our center. We will review 11C-Methionine PET data acquired within 30 days prior to surgery and analyze its principal imaging characteristics with respect to IDH1 mutation status, MGMT promoter methylation and 1p/19q co-deletion. These markers will be studied on tumor tissue obtained at surgery, used for diagnostic purposes and stored in paraffin.

Interventions

  • Other: No intervention
    • This is a retrospective study

Clinical Trial Outcome Measures

Primary Measures

  • Correlation of SUVmax (Maximal Standardized Uptake Value) in patients with glioma undergoing surgery with IDH1 mutation, MGMT promoter methylation and 1p/19q co-deletion,
    • Time Frame: Baseline SUVmax up to 1 month before surgery.

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of glioma – 11C-Methionine within 30 days before surgery Exclusion Criteria:

  • Absence of tumor specimen – No clinical data – 11C-Methionine can not be evaluated

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Istituto Clinico Humanitas
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Egesta Lopci, MD, Principal Investigator, Humanitas Clinical and Research Hospital

References

Lopci E, Franzese C, Grimaldi M, Zucali PA, Navarria P, Simonelli M, Bello L, Scorsetti M, Chiti A. Imaging biomarkers in primary brain tumours. Eur J Nucl Med Mol Imaging. 2015 Apr;42(4):597-612. doi: 10.1007/s00259-014-2971-8. Epub 2014 Dec 18.

Schinkelshoek M, Lopci E, Clerici E, Alongi F, Mancosu P, Rodari M, Navarria P, van der Hiel B, Scorsetti M, Chiti A. Impact of 11C-methionine positron emission tomography/computed tomography on radiation therapy planning and prognosis in patients with primary brain tumors. Tumori. 2014 Nov-Dec;100(6):636-44. doi: 10.1700/1778.19268. Erratum In: Tumori. 2018 Dec;104(6):480.

Navarria P, Reggiori G, Pessina F, Ascolese AM, Tomatis S, Mancosu P, Lobefalo F, Clerici E, Lopci E, Bizzi A, Grimaldi M, Chiti A, Simonelli M, Santoro A, Bello L, Scorsetti M. Investigation on the role of integrated PET/MRI for target volume definition and radiotherapy planning in patients with high grade glioma. Radiother Oncol. 2014 Sep;112(3):425-9. doi: 10.1016/j.radonc.2014.09.004. Epub 2014 Oct 9.

Riva M, Lopci E, Castellano A, Olivari L, Gallucci M, Pessina F, Fernandes B, Simonelli M, Navarria P, Grimaldi M, Ruda R, Castello A, Rossi M, Alfiero T, Soffietti R, Chiti A, Bello L. Lower Grade Gliomas: Relationships Between Metabolic and Structural Imaging with Grading and Molecular Factors. World Neurosurg. 2019 Jun;126:e270-e280. doi: 10.1016/j.wneu.2019.02.031. Epub 2019 Feb 22.

Lopci E, Riva M, Olivari L, Raneri F, Soffietti R, Piccardo A, Bizzi A, Navarria P, Ascolese AM, Ruda R, Fernandes B, Pessina F, Grimaldi M, Simonelli M, Rossi M, Alfieri T, Zucali PA, Scorsetti M, Bello L, Chiti A. Prognostic value of molecular and imaging biomarkers in patients with supratentorial glioma. Eur J Nucl Med Mol Imaging. 2017 Jul;44(7):1155-1164. doi: 10.1007/s00259-017-3618-3. Epub 2017 Jan 21.

Castello A, Riva M, Fernandes B, Bello L, Lopci E. The role of 11C-methionine PET in patients with negative diffusion-weighted magnetic resonance imaging: correlation with histology and molecular biomarkers in operated gliomas. Nucl Med Commun. 2020 Jul;41(7):696-705. doi: 10.1097/MNM.0000000000001202.

Riva M, Rodriguez Y Baena R, Pessina F, Lopci E, Fernandes B, Galli C, Rossi M, Bello L. The diffusion-weighted imaging and 11-C-methionine positron emission tomography depiction of an endodermal cyst at the cervico-medullary junction. Br J Neurosurg. 2015;29(5):739-41. doi: 10.3109/02688697.2015.1023780. Epub 2015 Mar 26.

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