11C-methionine in Diagnostics and Management of Glioblastoma Multiforme Patients (GlioMET)

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Glioblastoma multiforme (GBM) is the most common primary brain cancer. The treatment of GBM consists of a combination of surgery and subsequent oncological therapy, i.e. radiotherapy, chemotherapy, or combination of both at te same time. If post-operative oncological therapy involves irradiation, magnetic resonance imaging (MRI) is planned. Unfortunately, in some cases, a very early worsening (progression) or return (recurrence) of the disease is observed several weeks after the surgery, i.e. rapid early progression (REP). Radiotherapy planning is based on this MRI in all patients. However, a subset of patients with REP have a less favorable prognosis with this treatment management. The investigators therefore assume that these patients need a more thorough examination to form a precise radiotherapy plan. The project focuses on this group of patients with a less favorable prognosis (with a more aggressive disease). Patients who develop REP within approximately 6 weeks after surgery will have PET/CT (positron emission tomography in combination with computed tomography) examinations using the radiopharmaceutical 11C-methionine in addition to standard practice. PET is one of the most modern methods of molecular imaging, a non-invasive in vivo method that allows physicians to study processes in the human body using radiolabeled radiopharmaceuticals. 11C-methionine is an example of a radiolabeled (carbon 11) amino acid - a source of energy for tumor cells and a building material for new proteins. This radiopharmaceutical is commonly used in the diagnosis of brain tumors and in the evaluation of response to treatment. For patients who undergo this examination, the radiotherapy planning will be adjusted based on it. The purpose of clinical trial is to improve the prospects of patients with REP.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masaryk Memorial Cancer Institute
• Treatments: Carbon-11 methionine

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. Detected rapid early progression.

9. Patient must achieve following values of laboratory parameters in the peripheral blood during the screening period:

1. neutrophiles (total count) ≥1500/mm3

2. platelets (total count) ≥100 000/mm3

3. hemoglobin ≥ 9,0 g/dL

4. serum creatinin ≤1,5x of upper limit of normal, ULN

5. total bilirubin 1,5x ULN, unless documented Gilbert's syndrome, for which bilirubin ≤ 3x ULN is permitted

6. AST/ALT ≤3x ULN

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.