PET CT With HX4 in Cervix Cancer

Phase 2

Terminated

• Conditions: Cervix Cancer
• Interventions: Other: injection with [18F] HX4 and PET imaging

• Registration Number: NCT02233387
• Lead Sponsor: Maastricht Radiation Oncology

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.

Study Timeline

• Study First Submitted: 2012-02-29
• Study First Submitted QC: 2014-09-03
• Study First Posted: 2014-09-08
• Study Start: 2014-11
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-07
• Last Update Posted: 2019-03-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[18F] HX4 PET imaging	injection with [18F] HX4 and PET imaging	injection with \[18F\] HX4 and PET imaging at baseline and after 20 Gy radiotherapy

Primary Outcome Measures

Name	Time	Method
Visualisation of tumor hypoxia with [18F] HX4 PET imaging	2 year	Visualisation of tumor hypoxia with \[18F\] HX4 PET imaging

Secondary Outcome Measures

Name	Time	Method
Image quality of [18F] HX4-PET at different time points	2 year	Image quality of \[18F\] HX4-PET at different time points
Observation of spatial and temporal stability of [18F] HX4 PET images	2 year	Observation of spatial and temporal stability of \[18F\] HX4 PET images
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
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 blood hypoxia markers (osteopontin, circulating CA-IX)	2 year	Correlation of hypoxia imaging with blood hypoxia markers (osteopontin, circulating CA-IX)
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

Trial Locations

Locations (1)

MAASTRO clinic; 🇳🇱 Maastricht, Netherlands