HX4 in cervix cancer

Non invasive imaging of [18F]HX4 with Positron-Emission-Tomography (PET) in Cervix Cancer. - HX4-cervix

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000224-17-NL

Enrollment

Registered

2014-03-28

Start date

2014-09-15

Completion date

Unknown

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eligible patients with squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma (FIGO stage IB – IVA), to be treated with curative radiation treatment either or not combined with concurrent chemotherapy or deep hyperthermia are included

Interventions

Product Name: [18F]HX4 Product Code: [18F]HX4 Pharmaceutical Form: Radiopharmaceutical precursor, solution INN or Proposed INN: [18F]HX4 Other descriptive name: [18F]HX4 Concentration unit: MBq megabe

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

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
Main Objective: Visualization of tumor hypoxia with [18F] HX4 PET imaging;Secondary Objective: - Observation of spatial and temporal stability of [18F] HX4 PET images - Correlations with Complete Remission rates at 3 months restaging evaluation - Image quality of [18F] HX4-PET at different time points - Kinetic analysis of HX4 - 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, HIF-1a,) and autophagy related genes. - 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 ;Primary end point(s): Tumor to background ratio of [18F] HX4 PET images.;Timepoint(s) of evaluation of this end point: 2 years	—

Measure

Time frame

Main Objective: Visualization of tumor hypoxia with [18F] HX4 PET imaging;Secondary Objective: - Observation of spatial and temporal stability of [18F] HX4 PET images - Correlations with Complete Remission rates at 3 months restaging evaluation - Image quality of [18F] HX4-PET at different time points - Kinetic analysis of HX4 - 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, HIF-1a,) and autophagy related genes. - 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 ;Primary end point(s): Tumor to background ratio of [18F] HX4 PET images.;Timepoint(s) of evaluation of this end point: 2 years

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Secondary

Measure	Time frame
Secondary end point(s): - Overlap fraction of (for example) >50% max regions (i) before and during treatment (ii) in the time series. - Define the optimal time point for HX4 imaging in Cervix cancer, based on the highest tumor to background ratio. - Determine if there is a relationship between the SUVmax, SUVmean or tumor to muscle ratio in comparison to the amount of osteopontin in the blood, circulating CA-IX in the blood or the degree and presence of tumor tissue markers. - Overlap fraction of (for example) >50% max regions between HX4-PET and FDG-PET pre-treatment or three months after treatment. - Correlation of the SUVmax, SUVmean and tumor to muscle ratio in the [18F] HX4 PET images in comparison to local tumor recurrence and survival. - Correlation of the SUVmax, SUVmean and tumor to muscle ratio in the [18F] HX4 PET images in comparison to Complete Remission rates at 3 months ;Timepoint(s) of evaluation of this end point: 2 years	—

Measure

Time frame

Secondary end point(s): - Overlap fraction of (for example) >50% max regions (i) before and during treatment (ii) in the time series. - Define the optimal time point for HX4 imaging in Cervix cancer, based on the highest tumor to background ratio. - Determine if there is a relationship between the SUVmax, SUVmean or tumor to muscle ratio in comparison to the amount of osteopontin in the blood, circulating CA-IX in the blood or the degree and presence of tumor tissue markers. - Overlap fraction of (for example) >50% max regions between HX4-PET and FDG-PET pre-treatment or three months after treatment. - Correlation of the SUVmax, SUVmean and tumor to muscle ratio in the [18F] HX4 PET images in comparison to local tumor recurrence and survival. - Correlation of the SUVmax, SUVmean and tumor to muscle ratio in the [18F] HX4 PET images in comparison to Complete Remission rates at 3 months ;Timepoint(s) of evaluation of this end point: 2 years

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Countries

Netherlands

Contacts

Public ContactMAASTRO Clinic

MAASTRO Clinic

philippe.lambin@maastro.nl0031(0)884455666

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026