Diagnosis of early progression after glioblastoma surgery using 11C-methionine radiopharmaceutical

11C-METHIONIN IN DIAGNOSIS AND MANAGEMENT OF PATIENTS WITH AGGRESSIVE GLIOBLASTOM SHOWING A TIME POST-OPERATING PROGRESS BEFORE INITIATING ADJUVANT ONCOLOGICAL TREATMENT - GlioMET

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000640-64-CZ

Enrollment

142

Registered

2020-04-21

Start date

2020-05-26

Completion date

Unknown

Last updated

2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

REP (rapid early progression) after glioblastoma operation

Interventions

Product Name: Methionin (11C) methyl UJV 100 – 1500 MBq/ml injekcní roztok Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. The subject is a person with a histologically proven diagnosis of glioblastoma (GB) according to WHO 2016. 2. The subject is male or female, aged 18 years or older. 3. Performance status (PS) according to ECOG (Eastern Cooperative Oncology Group) 0-2. 4. Healed operation wound. 5. Post-operative MR up to 72 hours. 6. Indication to adjuvant chemoradiotherapy. 7. Patient has to express his/her informed consent and sign the form before the screening period. 8. Patient must achieve following values of laboratory parameters in the peripheral blood during the screening period: a. neutrophiles (total count) =1500/mm3 b. platelets (total count) =100 000/mm3 c. hemoglobin = 9,0 g/dL d. serum creatinin =1,5x of upper limit of normal, ULN e. total bilirubin 1,5x ULN, unless documented Gilbert’s syndrome, for which bilirubin = 3x ULN is permitted f. AST/ALT =3x ULN Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: 1. Prior brain surgery. 2. Prior radiotherapy targeting brain. 3. The history of active/currently treated cancer (solid tumor); the exceptions are: non-melanoma skin cancer, in situ bladder carcinoma, in situ gastric cancer, in situ colorectal carcinoma, in situ cervical carcinoma, in situ breast cancer. 4. Any systemic disease or health condition that might posses a risk at anticancer therapy and imaging techniques (MRI, MET PET). 5. Patients must not have substance abuse disorders that would interfere with cooperation with the requirements of the trial. 6. Patients must not have any evidence of ongoing (active) infection (HIV, hepatitis A, B, C). 7. Pregnant and/or breastfeeding women. 8. Patient who disagree and refuses to sign an Informed consent.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: •Prospective assessment of the incidence of REP on planning MRI in GB patients indicated to adjuvant chemoradiotherapy. •Evaluation of PFS in the group of patients with REP undergoing the MET PET optimized RT (Arm A) vs. PFS in the group of patients with no REP (Arm B). •Evaluation of overal survival (OS) in the group of patients with REP undergoing the MET PET optimized RT (Arm A) vs. OS in the respective historical retrospective cohort (Arm Ahist) vs. OS in the group of patients with no REP (Arm B). •Univariate and multivariate analysis of clinical factors and laboratory biomarkers in the whole group of prospectively enrolled GB patients, and in respective arms. •Identification of basic clinical and laboratory biomarkers of REP applicable to clinical practice. •Evaluation of spatial patterns of failure (central vs. in-field vs. marginal vs. distant) in MET PET cohort (Arm A) in comparison to retrospective REP cohort (Ahist.). ;Primary end point(s): PFS in Arm A vs. PFS in arm Ahist (median PFS in Arm A > median PFS in arm Ahist for =3,1 months).;Timepoint(s) of evaluation of this end point: This primary endpoint will be evaluated after all subjects are enrolled and reach the timepoint to evaluate PFS, i.e. progression of the disease.;Main Objective: The aim of the study is to prove the potential of 11C-MET PET/CT optimized radiotherapy to prolong the progression free survival in the group of glioblastoma patients with rapid early progression (Arm A) if compared with respective historical retrospective cohort (Arm Ahist).	—

Measure

Time frame

Secondary Objective: •Prospective assessment of the incidence of REP on planning MRI in GB patients indicated to adjuvant chemoradiotherapy. •Evaluation of PFS in the group of patients with REP undergoing the MET PET optimized RT (Arm A) vs. PFS in the group of patients with no REP (Arm B). •Evaluation of overal survival (OS) in the group of patients with REP undergoing the MET PET optimized RT (Arm A) vs. OS in the respective historical retrospective cohort (Arm Ahist) vs. OS in the group of patients with no REP (Arm B). •Univariate and multivariate analysis of clinical factors and laboratory biomarkers in the whole group of prospectively enrolled GB patients, and in respective arms. •Identification of basic clinical and laboratory biomarkers of REP applicable to clinical practice. •Evaluation of spatial patterns of failure (central vs. in-field vs. marginal vs. distant) in MET PET cohort (Arm A) in comparison to retrospective REP cohort (Ahist.). ;Primary end point(s): PFS in Arm A vs. PFS in arm Ahist (median PFS in Arm A > median PFS in arm Ahist for =3,1 months).;Timepoint(s) of evaluation of this end point: This primary endpoint will be evaluated after all subjects are enrolled and reach the timepoint to evaluate PFS, i.e. progression of the disease.;Main Objective: The aim of the study is to prove the potential of 11C-MET PET/CT optimized radiotherapy to prolong the progression free survival in the group of glioblastoma patients with rapid early progression (Arm A) if compared with respective historical retrospective cohort (Arm Ahist).

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Secondary

Measure	Time frame
Secondary end point(s): - Incidence of REP: PFS in arm A vs. PFS in arm B OS in arm A vs. OS in arm Ahist. - OS in arm A vs. OS in arm B - Characteristics of PoF in arm A vs. In arm Ahist. ;Timepoint(s) of evaluation of this end point: Incidence of REP could be evaluated after the enrollment is completed. Other characteristics could be evaluated after all subjects in all arms reach the respektive timepoints.	—

Measure

Time frame

Secondary end point(s): - Incidence of REP: PFS in arm A vs. PFS in arm B OS in arm A vs. OS in arm Ahist. - OS in arm A vs. OS in arm B - Characteristics of PoF in arm A vs. In arm Ahist. ;Timepoint(s) of evaluation of this end point: Incidence of REP could be evaluated after the enrollment is completed. Other characteristics could be evaluated after all subjects in all arms reach the respektive timepoints.

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Countries

Czech Republic

Contacts

Public ContactRegina Demlová

Masarykuv onkologický ústav

demlova@mou.cz

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026