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

Phase 1

Conditions: REP (rapid early progression) after glioblastoma operation
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2020-000640-64-CZ

Lead Sponsor: Masarykuv onkologický ústav

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 142

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

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.