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

Launched by MASARYK MEMORIAL CANCER INSTITUTE · Nov 3, 2022

Keywords

ClinConnect Summary

The GlioMET clinical trial is studying a new way to help patients with glioblastoma multiforme (GBM), which is a type of aggressive brain cancer. After surgery, some patients may experience a rapid worsening of their condition within a few weeks. This trial aims to improve treatment planning for these patients by using a specialized imaging technique called PET/CT, which involves a substance called 11C-methionine. This method helps doctors get a clearer picture of how the cancer is behaving and allows them to create a more tailored radiotherapy plan to improve patient outcomes.

To be eligible for the trial, participants must be at least 18 years old and have a confirmed diagnosis of GBM. They should have undergone surgery and show signs of early disease progression. Certain health conditions and past treatments may exclude a person from participating. If eligible, participants can expect to receive the standard care along with the additional PET/CT scan, which will help guide their treatment. This trial is currently active but not recruiting new participants, so it's important to check for updates if you or a loved one is interested.

Gender

ALL

Eligibility 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.