Clinical trial NCT02233387: PET CT With HX4 in Cervix Cancer
Official title: Non Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PET) in Cervix Cancer.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cervix Cancer
Keywords: cervix cancer
[18F] HX4 PET imaging
hypoxia
phase II trial
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
First posted: 2014-09-08
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visualisation of tumor hypoxia with [18F] HX4 PET imaging
timeFrame: 2 year
Secondary outcomes:
measure: Observation of spatial and temporal stability of [18F] HX4 PET images
timeFrame: 2 year
measure: Correlations with Complete Remission rates at 3 months restaging evaluation
timeFrame: 2 year
measure: Image quality of [18F] HX4-PET at different time points
timeFrame: 2 year
measure: Kinetic analysis of HX4
timeFrame: 2 year
measure: Correlation of hypoxia imaging with blood hypoxia markers (osteopontin, circulating CA-IX)
timeFrame: 2 year
measure: Correlation of hypoxia imaging with tumor tissue biomarkers (HPV, CA-IX, VEGF, EGFR, CD44, HIF-1α, mir-210) and autophagy related genes
timeFrame: 2 year
measure: Spatial correlation of [18F] HX4-PET with [18F] FDG PET pre-treatment
timeFrame: 2 year
measure: Spatial correlation of [18F] HX4-PET with [18F] FDG PET three months after treatment
timeFrame: 2 year
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: MAASTRO clinic
Study officials:
affiliation: Maastro Clinic, The Netherlands
name: Philippe Lambin, prof MD PhD
role: STUDY_DIRECTOR
References: