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Trial record 33 of 1118 for:    Recruiting, Not yet recruiting, Active, not recruiting, Completed, Enrolling by invitation, Approved for marketing Studies | glioblastoma

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

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ClinicalTrials.gov Identifier: NCT03739333
Recruitment Status : Recruiting
First Posted : November 12, 2018
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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).


Condition or disease Intervention/treatment Phase
Glioblastoma Other: 11C-Methionine PET-MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Early Diagnosis of Pseudoprogression Using 11C-Methionine PET-MRI After Concomitant Radiochemotherapy Treatment for Glioblastoma.
Actual Study Start Date : February 26, 2019
Estimated Primary Completion Date : February 26, 2020
Estimated Study Completion Date : January 26, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: patients with glioblastoma
implementation of 11C-Methionine PET-MRI
Other: 11C-Methionine PET-MRI
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 Measures :
  1. false negatives and false positives description (diagnosis accuracy) of 11C-Methionine PET-MRI [ Time Frame: within 1 months and 12 months post-treatment ]
    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 :
  1. ROC curves for comparison of two diagnostic tests: MRI and PET-MRI [ Time Frame: within 1 months and 24 months after inclusion ]
    use of area under the curve for each tests to identify the best

  2. The proportion of pseudoprogression identified by PET-MRI to 11C-MET according to the genetic data [ Time Frame: during 24 months after inclusion ]
    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.

  3. Overall survival analysis [ Time Frame: during 24 months after inclusion ]
    Patients will be followed regularly for 2 years to assess overall survival at 12 months and at 24 months.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,
  • Patients who have agreed to be included in the national file of individuals who are suitable for biomedical research

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739333


Contacts
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Contact: DUCRAY François, MD 00 (33) 4 72 68 13 21 francois.ducray@chu-lyon.fr
Contact: ISAL Sibel, MD 00 (33) 4 72 35 76 29 sibel.isal@chu-lyon.fr

Locations
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France
Hopices Civils de Lyon Recruiting
Bron, France, 69 677
Contact: DUCRAY François, MD    00 (33) 4 72 68 13 21    francois.ducray@chu-lyon.fr   
Contact: ISAL Sibel, MD    00 (33) 4 72 35 76 29    sibel.isal@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: DUCRAY François Hospîces Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03739333     History of Changes
Other Study ID Numbers: 69HCL18_0265
2018-002016-27 ( EudraCT Number )
First Posted: November 12, 2018    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
glioblastoma
11C-Methionine PET-MRI
sensitivity
temozolomide
radiotherapy
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue