NCT02518061

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2015

Typical duration 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

July 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

October 1, 2020

Status Verified

September 1, 2020

Enrollment Period

3.5 years

First QC Date

August 5, 2015

Last Update Submit

September 29, 2020

Conditions

Keywords

Glioma; 11C-Methionine PET

Outcome Measures

Primary Outcomes (1)

  • Correlation of SUVmax (Maximal Standardized Uptake Value) in patients with glioma undergoing surgery with IDH1 mutation, MGMT promoter methylation and 1p/19q co-deletion,

    Baseline SUVmax up to 1 month before surgery.

Interventions

This is a retrospective study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We will recruit a maximum number of 145 patients with glioma operated in our institution during 2011-2015, of which are available clinical and instrumental data and surgical tumor specimen.

You may qualify if:

  • Diagnosis of glioma
  • C-Methionine within 30 days before surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

Related Publications (7)

  • 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.

    PMID: 25520293BACKGROUND
  • 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.

    PMID: 25688497BACKGROUND
  • 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.

    PMID: 25308182BACKGROUND
  • 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.

    PMID: 30797926BACKGROUND
  • 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.

    PMID: 28110346BACKGROUND
  • 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.

    PMID: 32371671BACKGROUND
  • 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.

    PMID: 25812023BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tumor surgical specimen

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Egesta Lopci, MD

    Humanitas Clinical and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2015

First Posted

August 7, 2015

Study Start

July 1, 2015

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

October 1, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations