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Early Diagnosis of Pseudoprogression Using 11C-Methionine PET-MRI After Concomitant Radiochemotherapy Treatment for Glioblastoma. (TIGRE)

Primary Purpose

Glioblastoma

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
11C-Methionine PET-MRI
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glioblastoma focused on measuring glioblastoma, 11C-Methionine PET-MRI, sensitivity, temozolomide, radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 18 or over,
  • Patient with glioblastoma treated by radiochemotherapy with temozolomide,
  • Patient with suspicion of pseudoprogression between the 1st and 12th month after the end of concomitant chemoradiotherapy,
  • Patient receiving a social security scheme,
  • Patient for whom informed and written consent to participate has been obtained,

Exclusion Criteria:

  • Subject under safeguard of justice (tutelage, curatorship),
  • Minor patient,
  • Patient without signs of progression MRI (stable disease or good response to treatment according to the RANO 2010 criteria),
  • Clinical or radiological progression justifying a change of treatment,
  • Patient not able to decide and with refusal of the family entitled to continue research.
  • Pregnant woman, breastfeeding or old enough to have children but without effective contraception,
  • Contraindication to performing an MRI: permanently fixed metal parts (pacemaker, cerebral clip, cochlear implant, pin or screw for recent bone fracture, dental equipment, metal splinters), claustrophobia,
  • Contraindication to gadolinium according to ANSM 2017 recommendations

Sites / Locations

  • Hopices Civils de LyonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients with glioblastoma

Arm Description

implementation of 11C-Methionine PET-MRI

Outcomes

Primary Outcome Measures

false negatives and false positives description (diagnosis accuracy) of 11C-Methionine PET-MRI
diagnosis accuracy of 11C-MET PET-MRI to differentiated pseudoprogression from tumor recurrence, compared to MRI. The gold-standard being retrospective MRI analysis.

Secondary Outcome Measures

ROC curves for comparison of two diagnostic tests: MRI and PET-MRI
use of area under the curve for each tests to identify the best
The proportion of pseudoprogression identified by PET-MRI to 11C-MET according to the genetic data
The proportion of pseudoprogression identified by PET-MRI to 11C-MET according to the methylation status of the O6-methylguanine-DNA- methyltransferase (MGMT) promoter, the level of expression of isocitrate dehydrogenase (IDH) mutation, ki67 and 1p19q mutation.
Overall survival analysis
Patients will be followed regularly for 2 years to assess overall survival at 12 months and at 24 months.

Full Information

First Posted
November 6, 2018
Last Updated
February 12, 2020
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03739333
Brief Title
Early Diagnosis of Pseudoprogression Using 11C-Methionine PET-MRI After Concomitant Radiochemotherapy Treatment for Glioblastoma.
Acronym
TIGRE
Official Title
Early Diagnosis of Pseudoprogression Using 11C-Methionine PET-MRI After Concomitant Radiochemotherapy Treatment for Glioblastoma.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Recruiting
Study Start Date
February 26, 2019 (Actual)
Primary Completion Date
February 26, 2020 (Anticipated)
Study Completion Date
January 26, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Pseudoprogression is a phenomenon related to post-treatment rearrangements (including radiation necrosis). It appears early in the first year after treatment and accounts for 30 to 50% of patients followed with glioblastoma. On MRI (current gold standard with international therapeutic response evaluation criteria RANO 2010), pseudoprogression is manifested by a progression of morphological abnormalities (contrast enhancement, FLAIR hypersignal) and can simulate tumor recurrence, even though the corticosteroid improved or kept clinical symptoms stabilized. In view of prognosis, the current diagnostic tools have not enough diagnosis accuracy for differentiation between pseudo-progression and early tumor recurrence, and are based on MRI retrospective analysis (2-3 months after). Recurrence of glioblastoma, is characterized by a higher amino acid metabolism than pseudoprogression, also 11C-Methionine (11C-MET), positron emitting radiotracer, showed promising results to differentiate these two entities. To date, hybrid 11C-MET PET-MRI studies remains limited to small sample size (a few dozen patients), and none focuses exclusively on glioblastoma. Hypothesis of our study is that 11C-MET PET-MRI may be performed as a first-line MRI for suspected pseudoprogression and may changes therapeutic decision making and also patient prognosis. The main objective is to evaluate the performance of hybrid PET-MRI imaging with 11C-MET to differentiate pseudoprogression from glioblastoma recurrence in patients treated with surgery and radiochemotherapy, compared to multimodality MRI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
glioblastoma, 11C-Methionine PET-MRI, sensitivity, temozolomide, radiotherapy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients with glioblastoma
Arm Type
Experimental
Arm Description
implementation of 11C-Methionine PET-MRI
Intervention Type
Other
Intervention Name(s)
11C-Methionine PET-MRI
Intervention Description
Implementation 11C-Methionine PET-MRI performed for each patient in one place (department of nuclear medicine of Hospices Civils de Lyon). The 11C-Methionine PET-MRI will be performed after radiochemotherapy in patients with MRI suspicious of pseudoprogression.
Primary Outcome Measure Information:
Title
false negatives and false positives description (diagnosis accuracy) of 11C-Methionine PET-MRI
Description
diagnosis accuracy of 11C-MET PET-MRI to differentiated pseudoprogression from tumor recurrence, compared to MRI. The gold-standard being retrospective MRI analysis.
Time Frame
within 1 months and 12 months post-treatment
Secondary Outcome Measure Information:
Title
ROC curves for comparison of two diagnostic tests: MRI and PET-MRI
Description
use of area under the curve for each tests to identify the best
Time Frame
within 1 months and 24 months after inclusion
Title
The proportion of pseudoprogression identified by PET-MRI to 11C-MET according to the genetic data
Description
The proportion of pseudoprogression identified by PET-MRI to 11C-MET according to the methylation status of the O6-methylguanine-DNA- methyltransferase (MGMT) promoter, the level of expression of isocitrate dehydrogenase (IDH) mutation, ki67 and 1p19q mutation.
Time Frame
during 24 months after inclusion
Title
Overall survival analysis
Description
Patients will be followed regularly for 2 years to assess overall survival at 12 months and at 24 months.
Time Frame
during 24 months after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 18 or over, Patient with glioblastoma treated by radiochemotherapy with temozolomide, Patient with suspicion of pseudoprogression between the 1st and 12th month after the end of concomitant chemoradiotherapy, Patient receiving a social security scheme, Patient for whom informed and written consent to participate has been obtained, Exclusion Criteria: Subject under safeguard of justice (tutelage, curatorship), Minor patient, Patient without signs of progression MRI (stable disease or good response to treatment according to the RANO 2010 criteria), Clinical or radiological progression justifying a change of treatment, Patient not able to decide and with refusal of the family entitled to continue research. Pregnant woman, breastfeeding or old enough to have children but without effective contraception, Contraindication to performing an MRI: permanently fixed metal parts (pacemaker, cerebral clip, cochlear implant, pin or screw for recent bone fracture, dental equipment, metal splinters), claustrophobia, Contraindication to gadolinium according to ANSM 2017 recommendations
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DUCRAY François, MD
Phone
00 (33) 4 72 68 13 21
Email
francois.ducray@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
ISAL Sibel, MD
Phone
00 (33) 4 72 35 76 29
Email
sibel.isal@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DUCRAY François
Organizational Affiliation
Hospîces Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopices Civils de Lyon
City
Bron
ZIP/Postal Code
69 677
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DUCRAY François, MD
Phone
00 (33) 4 72 68 13 21
Email
francois.ducray@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
ISAL Sibel, MD
Phone
00 (33) 4 72 35 76 29
Email
sibel.isal@chu-lyon.fr

12. IPD Sharing Statement

Learn more about this trial

Early Diagnosis of Pseudoprogression Using 11C-Methionine PET-MRI After Concomitant Radiochemotherapy Treatment for Glioblastoma.

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