PET CT With HX4 in Cervix Cancer

Cervix Cancer Clinical Trial

— HX4-cervix  

Official title:

Non Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PET) in Cervix Cancer.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02233387
• Other study ID #: 11-36-14/12
• Status: Terminated
• Phase: Phase 2
• Start date: November 2014
• Est. completion date: May 2018

Study information

• Verified date: March 2019
• Source: Maastricht Radiation Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervix Cancer
• Uterine Cervical Neoplasms

Intervention

Other:
• injection 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

Locations

Country	Name	City	State
Netherlands	MAASTRO clinic	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visualisation of tumor hypoxia with [18F] HX4 PET imaging	Visualisation of tumor hypoxia with [18F] HX4 PET imaging	2 year
Secondary	Observation of spatial and temporal stability of [18F] HX4 PET images	Observation of spatial and temporal stability of [18F] HX4 PET images	2 year
Secondary	Correlations with Complete Remission rates at 3 months restaging evaluation	Correlations with Complete Remission rates at 3 months restaging evaluation	2 year
Secondary	Image quality of [18F] HX4-PET at different time points	Image quality of [18F] HX4-PET at different time points	2 year
Secondary	Kinetic analysis of HX4	Kinetic analysis of HX4	2 year
Secondary	Correlation of hypoxia imaging with blood hypoxia markers (osteopontin, circulating CA-IX)	Correlation of hypoxia imaging with blood hypoxia markers (osteopontin, circulating CA-IX)	2 year
Secondary	Correlation of hypoxia imaging with tumor tissue biomarkers (HPV, CA-IX, VEGF, EGFR, CD44, HIF-1a, mir-210) and autophagy related genes	Correlation of hypoxia imaging with tumor tissue biomarkers (HPV, CA-IX, VEGF, EGFR, CD44, HIF-1a, mir-210) and autophagy related genes	2 year
Secondary	Spatial correlation of [18F] HX4-PET with [18F] FDG PET pre-treatment	Spatial correlation of [18F] HX4-PET with [18F] FDG PET pre-treatment	2 year
Secondary	Spatial correlation of [18F] HX4-PET with [18F] FDG PET three months after treatment	Spatial correlation of [18F] HX4-PET with [18F] FDG PET three months after treatment	2 year