GliomaNCT02518061
11C-Methionine PET as Prognostic Marker of Gliomas
An observational study of Glioma, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- How many people
- 145 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2015to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Diagnosis of glioma
- 11C-Methionine within 30 days before surgery
Who cannot join
- Absence of tumor specimen
- No clinical data
- 11C-Methionine can not be evaluated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of 11C-Methionine PET for the Prognostic and Molecular Characterization of Gliomas Candidate to Surgery.
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.
Read the 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.
- Conditions
- Glioma
- Being tested
- No intervention
- Keywords
- Glioma; 11C-Methionine PET
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is a retrospective study
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of SUVmax (Maximal Standardized Uptake Value) in patients with glioma undergoing surgery with IDH1 mutation, MGMT promoter methylation and 1p/19q co-deletion,
Measured: Baseline SUVmax up to 1 month before surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startJul 2015
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Egesta Lopci, MD, Principal investigator, Humanitas Clinical and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518061
- Sponsor's protocol ID
- 1418
- Status last verified
- Sep 2020
- First submitted
- 5 Aug 2015
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25520293Schinkelshoek 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.
PubMed 25688497Navarria 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.
PubMed 25308182Riva 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.
PubMed 30797926Lopci 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.
PubMed 28110346Castello 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.
PubMed 32371671Riva 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.
PubMed 25812023
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of 11C-Methionine PET for the Prognostic and Molecular Characterization of Gliomas Candidate to Surgery.
- ClinicalTrials.gov ID
- NCT02518061
- Acronym / sponsor ID
- 1418
- Conditions
- Glioma
- Keywords
- Glioma; 11C-Methionine PET
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Diagnosis of glioma
- 11C-Methionine within 30 days before surgery
Key exclusion criteria (3 listed)
- Absence of tumor specimen
- No clinical data
- 11C-Methionine can not be evaluated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is a retrospective study | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Background: PubMed 25520293Lopci 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.
- Background: PubMed 25688497Schinkelshoek 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.
- Background: PubMed 25308182Navarria 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.
- Background: PubMed 30797926Riva 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.
- Background: PubMed 28110346Lopci 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.
- Background: PubMed 32371671Castello 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.
- Background: PubMed 25812023Riva 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.
- Individual participant dataSharing planned: No
Related trials for Glioma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Egesta Lopci, MD principal investigator
Humanitas Clinical and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02518061, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.