Hypoxia Analysis in Head and/or Neck Cancer

NCT02414048 | Unknown Phase 2

• 1 other identifier: KEK-Nr.2014-0393
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is the prospective determination of disease-specific and overall survival in head and neck cancer patients who have undergone surgery, correlated to non-invasive methods of measuring tumour hypoxia. The secondary objective is to define tumour hypoxia using non-invasive methodology.

Conditions

Head and Neck Cancer

Keywords

Hypoxia; Head and neck cancer

Outcome Measures

Primary Outcomes (1)

• Disease-specific and overall survival correlated with tumour hypoxia

  Tumour hypoxia will be determined from the Pimonidazole staining and this will be correlated to disease-specific survival and overall survival. The study has been approved for 10 participants to be increased by the ethical committee to 100 once the study is going.

  5-years

Study Arms (1)

Pimonidazole

OTHER

All patients will receive Pimonidazole to demarcate hypoxia regions in the tumour

Drug: Pimonidazole

Interventions

Pimonidazole DRUG

Pimonidazole will be administered orally and will serve to demarcate the hypoxic areas in the tumour

Also known as: Oral Hypoxyprobe

Pimonidazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Malignancy in head and/or neck region only
• For patients with reproductive potential (e.g. female participants who are surgically sterilised/hysterectomised or post-menopausal for longer than 2 years are not considered as beig of child bearing potential), a willingness to use adequate contraceptive measures to prevent pregnancy during the project.

You may not qualify if:

• Pregnant or breastfeeding
• Suffers from claustrophobia
• Known allergy to Pimonidazole
• Participation in a study with an investigational drug within the 30 days preceding and during this project
• Tumour size smaller than 1cm
• Has symptomatic Chronic Obstructive Pulmonary Disease (COPD)
• Patient refuses or is unable to give a written informed consent
• Previous treatment for head and/or neck cancer
• Inability to follow the procedures of the project e.g. due to language problems, psychological disorders, dementia, etc. of the participant.

Sponsors & Collaborators

• Marius Gustav Bredell: lead

Study Sites (1)

Department of Cranio-, Maxillofacial and Oral Surgery

Zurich, 8090, Switzerland

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Hypoxia

Interventions

pimonidazole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marius Bredell

  Department of Cranio-, Maxillofacial and Oral Surgery, University Hospital Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Hager

CONTACT

christine.hager@usz.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 10, 2015
• Study Start: April 1, 2015
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: June 17, 2016

Record last verified: 2016-06

Locations

CH (1)