hersenen, primaire maligne glioom of metastasen cancer: several diseases
Conditions
Interventions
None listed
Sponsors
MAASTRO Clinic
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet the general and tumor site specific criteria:;General: - Histological/cytological confirmed carcinoma of de esophagus, rectum or prostate or radiological suspicion for Grade IV glioma (primary brain tumor) or brain metastases. - WHO performance status 0 to 2. - Adequate renal function (calculated creatinine clearance at least 60 ml/min). - The patient is willing and capable to comply with study procedures - 18 years or older - Have given written informed consent before patient registration;Prostate - Histological confirmed prostate tumor - High grade tumor (Gleason score *8) - Macroscopically visual tumor on MRI - Tumorload based on biopsy > 25% - No previous surgery of the prostate. - No previous radiotherapy of the prostate - No previous chemotherapy or hormonal therapy;Esophagus - Histological or cytological confirmed adenocarcinoma of the esophagus - Tumor diameter * 2,5 cm - No previous surgery to the esophagus - No previous radiotherapy of the esophagus. - No previous chemotherapy.;Primary brain tumor (Grade IV glioma) - Suspected grade IV glioma on magnetic resonance imaging - Macroscopically visual tumor on MRI (diameter larger than 2 cm) - No previous radiotherapy, chemotherapy or surgery;Brain (metastases) - Raiological suspicion for brain metastases:macroscopically visual tumor on MRI (diameter larger than 2 cm and suitable for SBRT) - Planned for curative treatment with stereotactic body radiotherapy (SBRT);Rectum - Histologically confirmed rectum tumor - Tumor size length * 2,5 cm - Eligible for long-course radiochemotherapy - No previous surgery or radiotherapy of the rectum - No previous chemotherapy
Exclusion criteria
Exclusion criteria: - Recent (< 3 months) myocardial infarction;- Pregnant or breast feeding and willing to take adequate contraceptive measures during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor to background ratio of [18F] HX4 PET images. This endpoint will be evaluated approximately 3 months after inclusion of all patients | — |
Secondary
| Measure | Time frame |
|---|---|
| - Correlation of the SUVmax, SUVmean, SUVpeak and tumor to background ratio in the [18F] HX4 PET images in comparison to local tumor recurrence and survival. - Determine if there is a relationship between the SUVmax, SUVmean, SUVpeak or tumor to background ratio in comparison to blood or tissue biomarkers. - Overlap fraction of (for example) >50% max regions between HX4-PET and FDG-PET pre-treatment or three months after treatment. - Quantitative and qualitative correlation of [18F] HX4-PET obtained before treatment and two weeks into treatment These secondary endpoints will be evaluated 2 years after the inclusion of all patients, since we want correlate hypoxia PET imaging to (at least) 2-year overall survival. | — |
Countries
Netherlands
Outcome results
None listed