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

NCT03739333 | Unknown

• 2 other identifiers: 69HCL18_02652018-002016-27
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Glioblastoma

Keywords

glioblastoma; 11C-Methionine PET-MRI; sensitivity; temozolomide; radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  within 1 months and 12 months post-treatment

Secondary Outcomes (3)

• ROC curves for comparison of two diagnostic tests: MRI and PET-MRI

  within 1 months and 24 months after inclusion

• The proportion of pseudoprogression identified by PET-MRI to 11C-MET according to the genetic data

  during 24 months after inclusion

• Overall survival analysis

  during 24 months after inclusion

Study Arms (1)

patients with glioblastoma

EXPERIMENTAL

implementation of 11C-Methionine PET-MRI

Other: 11C-Methionine PET-MRI

Interventions

11C-Methionine PET-MRI OTHER

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.

patients with glioblastoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hopices Civils de Lyon

Bron, 69 677, France

RECRUITING

MeSH Terms

Conditions

Glioblastoma; Hypersensitivity

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Immune System Diseases

Study Officials

• DUCRAY François

  Hospîces Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DUCRAY François, MD

CONTACT

00 (33) 4 72 68 13 21; francois.ducray@chu-lyon.fr

ISAL Sibel, MD

CONTACT

00 (33) 4 72 35 76 29; sibel.isal@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 13, 2018
• Study Start: February 26, 2019
• Primary Completion: February 26, 2020
• Study Completion: January 26, 2025
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

FR (1)