NCT00388687

Brief Summary

The aim of this study is to visualize the tumor hypoxic tissue, the potential quantitative changes and the biological behavior of cervical carcinoma (primary and / or lymph nodes) before, during and after radiochemotherapy with the novel hypoxia PET tracer 18FAZA.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2006

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

Study Start

First participant enrolled

July 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

October 17, 2006

Status Verified

October 1, 2006

First QC Date

October 16, 2006

Last Update Submit

October 16, 2006

Conditions

Uterine Cervical Neoplasms

Keywords

HypoxiaFAZAPETRadiochemotherapy

Interventions

18F Fluoroazomycin Arabinoside (FAZA)DRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First diagnosis of histologically proven cervical cancer FIGO stage IB2 to IVA.
  • Treatment intention for the purpose of achieving cure
  • Age \< 80 years
  • No previous standard or radical hysterectomy

You may not qualify if:

  • Pregnancy, breast-feeding women, patients that are not able to lie motionless for one hour.Palliative treatment, recurrent disease, neoadjuvant chemotherapy, other pre-existing malignancies, age \> 80 years,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical Universitiy of Vienna

Vienna, 1090, Austria

RECRUITING

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Uterine Cervical NeoplasmsHypoxia

Interventions

fluoroazomycin arabinoside

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

Study Officials

  • Georgios Karanikas, Prof. M.D.

    Medical Universitiy of Vienna

    STUDY DIRECTOR

Central Study Contacts

Matthias Schuetz, M.D.

CONTACT

00431404005550matthias.schuetz@meduniwien.ac.at

Barbara Bachtiary, Prof. M.D

CONTACT

00431404007676barbara.bachtiary@meduniwien.ac.at

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 16, 2006

First Posted

October 17, 2006

Study Start

July 1, 2006

Study Completion

July 1, 2007

Last Updated

October 17, 2006

Record last verified: 2006-10

Locations

AU(2)