Cervix Cancer
Conditions
Keywords
cervix cancer, [18F] HX4 PET imaging, hypoxia, phase II trial
Brief summary
The aim of this study is: 1. to determine if tumor hypoxia can be accurately visualised with \[18F\]HX4 PET imaging in cervix cancer, 2. to correlate the \[18F\]HX4 PET images with blood and tissue markers, 3. to investigate the quality and optimal timing of \[18F\]HX4 PET images, 4. to compare \[18F\]HX4 PET uptake with \[18F\]FDG PET uptake before and after treatment and 5. analyze correlation with responses
Detailed description
Tumor hypoxia is the situation where tumor cells are or have been deprived of oxygen. Hypoxic tumor cells are usually more resistant to radiotherapy and chemotherapy and more likely to develop metastasis. In Cervix cancer, tumor hypoxia is known to be an important prognostic factor for long term survival. \[18F\]HX4 is being developed as a diagnostic radiopharmaceutical for PET imaging to find a marker for hypoxia that can be used in standard clinical practice. Current hypoxia tracers lack reliable image quality and kinetics. Because of the short half life and clearance, the investigators expect that \[18F\]HX4 will have a higher tumor to background ratio than current nitro-imidazole hypoxia markers such as \[18F\]-misonidazole. In a recent phase 1 clinical study from van Loon et al, PET-imaging with \[18F\]HX4 was feasible without any toxicity. The clinical use of a reliable, non-invasive and easy to use hypoxia imaging agent could allow selection of patients most likely to benefit from hypoxia modifying therapies.
Interventions
OTHERinjection with [18F] HX4 and PET imaging
A standard clinical \[18F\]FDG PET-CT will be performed for the radiotherapy planning. After a minimum time interval of 24 hours, baseline \[18F\]HX4 PET scans will be performed: Based on the phase I trial1 444 MBq (12 mCi) \[18F\]HX4 is administrated via a bolus IV injection. The first image acquisition is started together with the administration of \[18F\]HX4 (30-40 min dynamic). Static scans are acquired at 90 min, 180 min and 240 min p.i
Sponsors
Maastricht Radiation Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed cervix carcinoma (squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma) * tumor stages FIGO IB - IVA * WHO performance status 0 to 2 * Scheduled for primary curative radiotherapy (either or not combined with chemotherapy or hyperthermia) * No previous surgery to the Cervix * No previous radiation to the Cervix * The patient is willing and capable to comply with study procedures * 18 years or older * Written informed consent before patient registration
Exclusion criteria
* Recent (\< 3 months) myocardial infarction * Uncontrolled infectious disease * Pregnant or breast feeding and/or not willing to take adequate contraceptive measures during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visualisation of tumor hypoxia with [18F] HX4 PET imaging | 2 year | Visualisation of tumor hypoxia with \[18F\] HX4 PET imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of hypoxia imaging with blood hypoxia markers (osteopontin, circulating CA-IX) | 2 year | Correlation of hypoxia imaging with blood hypoxia markers (osteopontin, circulating CA-IX) |
| Observation of spatial and temporal stability of [18F] HX4 PET images | 2 year | Observation of spatial and temporal stability of \[18F\] HX4 PET images |
| Correlations with Complete Remission rates at 3 months restaging evaluation | 2 year | Correlations with Complete Remission rates at 3 months restaging evaluation |
| Kinetic analysis of HX4 | 2 year | Kinetic analysis of HX4 |
| Correlation of hypoxia imaging with tumor tissue biomarkers (HPV, CA-IX, VEGF, EGFR, CD44, HIF-1α, mir-210) and autophagy related genes | 2 year | Correlation of hypoxia imaging with tumor tissue biomarkers (HPV, CA-IX, VEGF, EGFR, CD44, HIF-1α, mir-210) and autophagy related genes |
| Spatial correlation of [18F] HX4-PET with [18F] FDG PET pre-treatment | 2 year | Spatial correlation of \[18F\] HX4-PET with \[18F\] FDG PET pre-treatment |
| Spatial correlation of [18F] HX4-PET with [18F] FDG PET three months after treatment | 2 year | Spatial correlation of \[18F\] HX4-PET with \[18F\] FDG PET three months after treatment |
| Image quality of [18F] HX4-PET at different time points | 2 year | Image quality of \[18F\] HX4-PET at different time points |
Countries
Netherlands
Outcome results
None listed