NCT02233387

Brief Summary

The aim of this study is:

  1. 1.to determine if tumor hypoxia can be accurately visualised with \[18F\]HX4 PET imaging in cervix cancer,
  2. 2.to correlate the \[18F\]HX4 PET images with blood and tissue markers,
  3. 3.to investigate the quality and optimal timing of \[18F\]HX4 PET images,
  4. 4.to compare \[18F\]HX4 PET uptake with \[18F\]FDG PET uptake before and after treatment and
  5. 5.analyze correlation with responses

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 29, 2012

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

September 8, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

March 8, 2019

Status Verified

March 1, 2019

Enrollment Period

3.5 years

First QC Date

February 29, 2012

Last Update Submit

March 7, 2019

Conditions

Cervix Cancer

Keywords

cervix cancer[18F] HX4 PET imaginghypoxiaphase II trial

Outcome Measures

Primary Outcomes (1)

  • Visualisation of tumor hypoxia with [18F] HX4 PET imaging

    Visualisation of tumor hypoxia with \[18F\] HX4 PET imaging

    2 year

Secondary Outcomes (8)

  • Observation of spatial and temporal stability of [18F] HX4 PET images

    2 year

  • Correlations with Complete Remission rates at 3 months restaging evaluation

    2 year

  • Image quality of [18F] HX4-PET at different time points

    2 year

  • Kinetic analysis of HX4

    2 year

  • Correlation of hypoxia imaging with blood hypoxia markers (osteopontin, circulating CA-IX)

    2 year

  • +3 more secondary outcomes

Study Arms (1)

[18F] HX4 PET imaging

EXPERIMENTAL

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

Other: injection with [18F] HX4 and PET imaging

Interventions

injection with [18F] HX4 and PET imagingOTHER

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

Also known as: 3-[18F]fluoro- 2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-1H-1,2,3-triazol-1- yl)propan-1-ol
[18F] HX4 PET imaging

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years or older
  • Written informed consent before patient registration

You may not qualify if:

  • Recent (\< 3 months) myocardial infarction
  • Uncontrolled infectious disease
  • Pregnant or breast feeding and/or not willing to take adequate contraceptive measures during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MAASTRO clinic

Maastricht, 6229 ET, Netherlands

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsHypoxia

Interventions

InjectionsMagnetic Resonance Spectroscopy3-fluoro-2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-1H-1,2,3-triazol-1-yl)propan-1-ol

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Philippe Lambin, prof MD PhD

    Maastro Clinic, The Netherlands

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2012

First Posted

September 8, 2014

Study Start

November 1, 2014

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

March 8, 2019

Record last verified: 2019-03

Locations

NL(1)