on invasive imaging of tumor hypoxia with [18F]HX4 Positron-Emission-Tomography (PET): A phase II trial

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

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

- Recent (< 3 months) myocardial infarction;- Pregnant or breast feeding and willing to take adequate contraceptive measures during the study

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Tumor to background ratio of [18F] HX4 PET images.<br /><br><br /><br>This endpoint will be evaluated approximately 3 months after inclusion of all<br /><br>patients</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Correlation of the SUVmax, SUVmean, SUVpeak and tumor to background ratio in<br /><br>the [18F] HX4 PET images in comparison to local tumor recurrence and survival.<br /><br>- Determine if there is a relationship between the SUVmax, SUVmean, SUVpeak or<br /><br>tumor to background ratio in comparison to blood or tissue biomarkers.<br /><br>- Overlap fraction of (for example) >50% max regions between HX4-PET and<br /><br>FDG-PET pre-treatment or three months after treatment.<br /><br>- Quantitative and qualitative correlation of [18F] HX4-PET obtained before<br /><br>treatment and two weeks into treatment<br /><br><br /><br>These secondary endpoints will be evaluated 2 years after the inclusion of all<br /><br>patients, since we want correlate hypoxia PET imaging to (at least) 2-year<br /><br>overall survival.</p><br>