Tumor Hypoxia With HX4 PET in Several Diseases
Հիմնաբառեր
Վերացական
Նկարագրություն
Rationale: Non-invasive imaging of hypoxia with the aid of PET-scans could help to select the patients having a hypoxic tumor, who could be treated with specific anti-hypoxic treatments. The added value of additional anti-hypoxic treatments depends on the presence of hypoxia and adequate patient selection. Several 2-nitroimidazoles, labeled with Fluor-18 (18F) have already been used in patients to identify hypoxia. However, suboptimal image quality and unpredictable kinetics limit their use. In extensive pre-clinical models and clinical trials the combination of HX4 labeled with 18F showed to be a promising and non-toxic new probe to determine hypoxia. With this tracer the proportion of hypoxic tumors in several cancer types will be verified.
Objective: Determine if tumor hypoxia can be accurately visualized with [18F]HX4 in solid lesions.
Study design: Phase II, several solid tumors, single-centre, imaging, non-randomized, open label trial.
Study population:
Main patient characteristics are:
- 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).
- Capable of complying with study procedures
Main intervention: In addition to standard clinical care patients receive two additional PET scans after injection with the hypoxia tracer [18F]HX4.
Main study parameters/endpoints:
- Visualization and quantification of tumor hypoxia with [18F] HX4 PET imaging
- Exploring the potential relationship between [18F] HX4 uptake with local and locoregional tumor recurrence and survival
- Correlation of hypoxia imaging with blood hypoxia markers
- Correlation of hypoxia imaging with tumor tissue biomarkers
- Evaluation of tumor hypoxia changes during treatment.
- Spatial correlation of [18F] HX4-PET with imaging pre-treatment (if present from routine clinical practice)
- Spatial correlation of [18F] HX4-PET with imaging three months after treatment (if present from routine clinical practice)
- Quantitative and qualitative correlation of [18F] HX4-PET obtained before treatment and two weeks into treatment
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The radiation burden due to [18F]HX4 is similar to that encountered in many routine nuclear medicine procedures e.g. [18F]FDG PET. Administration of [18F]HX4 presents no known risks. In previous studies (healthy volunteers, phase I, phase II) no adverse effects were observed. There are no immediate potential benefits except the satisfaction to participate to improve of knowledge.
Ամսաթվերը
| Վերջին ստուգումը: | 02/28/2019 |
| Առաջինը ներկայացվում է: | 10/06/2015 |
| Մոտավոր գրանցումը ներկայացված է: | 10/20/2015 |
| Առաջին տեղադրումը: | 10/21/2015 |
| Վերջին թարմացումը ներկայացված է: | 03/06/2019 |
| Վերջին թարմացումը տեղադրված է: | 03/07/2019 |
| Ուսումնասիրության իրական մեկնարկի ամսաթիվը: | 04/30/2016 |
| Նախնական ավարտման նախնական ամսաթիվը: | 04/30/2017 |
| Ուսումնասիրության ավարտի գնահատման ամսաթիվը: | 04/30/2017 |
Վիճակ կամ հիվանդություն
Միջամտություն / բուժում
Drug: [18F]HX4 PET imaging
Փուլ
Arm խմբերը
| Արմ | Միջամտություն / բուժում |
|---|---|
| Experimental: [18F]HX4 PET imaging Injection with the hypoxia tracer [18F]HX4 and PET imaging at baseline for esophageal, rectal, prostate cancer, primary brain tumor (grade IV glioma) and brain metastases and after 2 weeks of radiotherapy for esophageal, rectal and brain metastases | Drug: [18F]HX4 PET imaging The [18F]HX4 PET scan will be performed, by administrating 444 MBq (12 mCi) [18F]HX4 via a bolus IV injection. |
Իրավասության չափանիշներ
| Ուսման իրավունք ունեցող դարաշրջանները | 18 Years Դեպի 18 Years |
| Ուսումնասիրության իրավունք ունեցող սեռերը | All |
| Ընդունում է առողջ կամավորներ | Այո |
| Չափանիշներ | Inclusion Criteria: - 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 Exclusion Criteria: - Recent (< 3 months) myocardial infarction - Pregnant or breast feeding and willing to take adequate contraceptive measures during the study |
Արդյունք
Արդյունքների առաջնային միջոցառումներ
1. Visualization of tumor hypoxia with [18F] HX4 PET imaging, valuated by the measurement of a tumor-to-background (T/B) ratio on the [18F]HX4 PET/CT [4 years]
2. Quantification of tumor hypoxia with [18F] HX4 PET imaging, evaluated by the measurement of a tumor-to-background (T/B) ratio on the [18F]HX4 PET/CT [4 years]
Արդյունքների երկրորդական միջոցներ
1. Time between [18F] HX4 uptake with local and locoregional tumor recurrence and survival [4 years]
2. Correlation of hypoxia imaging with blood hypoxia markers will be measured by the Pearson or Spearman correlation coefficient [4 years]
3. Correlation of hypoxia imaging with tumor tissue biomarkers will be measured by the Pearson or Spearman correlation coefficient [4 years]
4. Evaluation of tumor hypoxia changes during treatment by comparison of the PET uptake values in the tumor, measured before and during treatment [4 years]
5. Spatial correlation of [18F] HX4-PET with imaging pre-treatment using a correlation coefficient [4 years]
6. Spatial correlation of [18F] HX4-PET with imaging three months after treatment using a correlation coefficient [3 months]
