E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Eligible patients with histologically/cytologically proven primary tumors of the prostate, esophagus, brain or rectum or metastatic disease to the brain (originating from breast, lung or colorectal). |
|
E.1.1.1 | Medical condition in easily understood language |
Cancer of the prostate, esophagus, brain or rectum or metastatic disease to the brain (originating from breast, lung or colorectal). |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Tumor to background ratio of [18F] HX4 PET images. |
|
E.2.2 | Secondary objectives of the trial |
- 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
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
General:
- Primary tumor site: prostate, esophagus, grade IV glioma or rectum
- Metastastic disease to brain (originating from e.g., breast, lung or colorectal primary tumor)
- WHO performance status 0 to 2
- No chronic renal function failure or no renal dialysis
- 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%
- Eligible for HDR-brachytherapy followed by external beam radiotherapy
- No previous surgery of the prostate.
- No previous radiotherapy of the prostate
- No previous chemotherapy or hormonal therapy
Esophagus
- Histological or cytological confirmed esophageal tumor
- Tumor length ≥ 2,5 cm
- No previous surgery to the esophagus
- No previous radiotherapy of the esophagus.
- No previous chemotherapy.
Brain (primary)
- Preferably histologically proven, or highly suspicious for malignancy
- Primary grade IV glioma (glioblastoma)
- Macroscopically visual tumor on MRI ( , diameter larger than 0.5cm)
- No complete tumor removal at surgery, only biopsy or partial debulking
- no previous chemotherapy
Brain (metastases)
- brain metastases (originating from the lung, breast or colorectal)
- macroscopically visual tumor on MRI (diameter larger than 1.5 cm and suitable for SBRT)
- planned for curative treatment with stereotactic body radiotherapy (SBRT)
- No chemotherapy 4 weeks before planned scan-date.
Rectum
- Histologically confirmed rectum tumor
- tumor size diameter ≥ 2,5 cm
- eligible for long-course radiochemotherapy
- No previous surgery or radiotherapy of the rectum
- No previous chemotherapy |
|
E.4 | Principal exclusion criteria |
- Recent (< 3 months) myocardial infarction
- Pregnant or breast feeding and willing to take adequate contraceptive measures during the study
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Tumor to background ratio of [18F] HX4 PET images. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
This endpoint will be evaluated approximately 3 months after inclusion of all patients. |
|
E.5.2 | Secondary end point(s) |
- 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
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |