PET CT With HX4 in Cervix Cancer (HX4-cervix)

March 7, 2019 updated by: Maastricht Radiation Oncology

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6229 ET
        • Maastro Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: [18F] HX4 PET imaging
injection with [18F] HX4 and PET imaging at baseline and after 20 Gy radiotherapy
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

Other Names:
  • 3-[18F]fluoro- 2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-1H-1,2,3-triazol-1- yl)propan-1-ol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visualisation of tumor hypoxia with [18F] HX4 PET imaging
Time Frame: 2 year
Visualisation of tumor hypoxia with [18F] HX4 PET imaging
2 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht Radiation Oncology

Investigators

  • Study Director: Philippe Lambin, prof MD PhD, Maastro Clinic, The Netherlands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (ACTUAL)

May 1, 2018

Study Completion (ACTUAL)

May 1, 2018

Study Registration Dates

First Submitted

February 29, 2012

First Submitted That Met QC Criteria

September 3, 2014

First Posted (ESTIMATE)

September 8, 2014

Study Record Updates

Last Update Posted (ACTUAL)

March 8, 2019

Last Update Submitted That Met QC Criteria

March 7, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-36-14/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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