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

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ClinicalTrials.gov Identifier: NCT02233387
Recruitment Status : Unknown
Verified January 2016 by Maastricht Radiation Oncology.
Recruitment status was:  Recruiting
First Posted : September 8, 2014
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Cervix Cancer Other: injection with [18F] HX4 and PET imaging Phase 2

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PET) in Cervix Cancer.
Study Start Date : November 2014
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Visualisation of tumor hypoxia with [18F] HX4 PET imaging [ Time Frame: 2 year ]
    Visualisation of tumor hypoxia with [18F] HX4 PET imaging


Secondary Outcome Measures :
  1. 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. Correlations with Complete Remission rates at 3 months restaging evaluation [ Time Frame: 2 year ]
    Correlations with Complete Remission rates at 3 months restaging evaluation

  3. Image quality of [18F] HX4-PET at different time points [ Time Frame: 2 year ]
    Image quality of [18F] HX4-PET at different time points

  4. Kinetic analysis of HX4 [ Time Frame: 2 year ]
    Kinetic analysis of HX4

  5. 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)

  6. 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

  7. 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

  8. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02233387


Contacts
Contact: Ludy Lutgens, MD,PhD +31 88 44 55 666 ludy.lutgens@maastro.nl

Locations
Netherlands
MAASTRO clinic Recruiting
Maastricht, Netherlands, 6229 ET
Contact: Ludy Lutgens, MD, PhD    +31 88 44 55 666    ludy.lutgens@maastro.nl   
Sponsors and Collaborators
Maastricht Radiation Oncology
Investigators
Study Director: Philippe Lambin, prof MD PhD Maastro Clinic, The Netherlands

Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT02233387     History of Changes
Other Study ID Numbers: 11-36-14/12
First Posted: September 8, 2014    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016

Keywords provided by Maastricht Radiation Oncology:
cervix cancer
[18F] HX4 PET imaging
hypoxia
phase II trial

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female