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Trial record 40 of 1326 for:    Recruiting, Not yet recruiting, Available Studies | "Head and Neck Neoplasms"

Oxygen Enhanced MRI Measurement in Head and Neck Cancer: Validation and Efficacy of Response.

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ClinicalTrials.gov Identifier: NCT03646747
Recruitment Status : Not yet recruiting
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Collaborator:
University of Manchester
Information provided by (Responsible Party):
Sally Falk, The Christie NHS Foundation Trust

Brief Summary:
This is a prospective pilot study to investigate the potential clinical value of oxygen-enhanced magnetic resonance (OE-MRI) biomarkers in head and neck radiotherapy.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Diagnostic Test: MRI scan Not Applicable

Detailed Description:

This is a prospective pilot study funded by the NIHR. Healthy participants and patients will be recruited in The Christie NHS Foundation Trust and will be asked to undergo oxygen-enhanced magnetic resonance imaging (OE-MRI) and dynamic contrast-enhanced MRI (DCE-MRI). This study builds on the work recently been completed in lung cancer. Clinical data will be collected from patients notes.

Tumour hypoxia is common in solid tumours and associated with poor response to radiotherapy, poor loco-regional control and survival outcomes in head and neck cancer. There is a need to develop non-invasive tests that can measure tumour hypoxia to improve radiotherapy for these patients. The study will involve 3 components:

  1. Reproducibility and feasibility: The reproducibility of OE-MRI in head and neck cancer is unknown. Ten healthy participants will be asked to undergo two baseline OE-MRI scans with either nasal cannula or facial mask to breathe air and oxygen throughout. The order of which non-invasive breathing method will be used first will be randomized.

    Following this initial pilot OE-MRI will be tested in 30 patients with solid head and neck tumours. To assess reproducibility in patients 2 OE-MRI will be performed at baseline.

  2. Effect of radiotherapy on tumour and normal tissue: OE-MRI and DCE-MRI signals will be measured at baseline before standard radiotherapy treatment begins and at the end of week 2 week and week 4 following the start of radiotherapy. Comparison of hypoxia measurements will be taken.
  3. Biological validation: All 30 patients will undergo a diagnostic biopsy as standard of care at their local hospital. Tissue samples will be requested and multi-gene hypoxia signatures will be tested. OE-MRI signals will be compared with tissue sample from the same patient and the presence of changes in tumour known to be associated with hypoxia will be analysed.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single site, non-randomised basic science study
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Oxygen Enhanced MRI Measurement in Head and Neck Cancer: Validation and Efficacy of Response.
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MRI scan

10 healthy participants will be asked to undergo two baseline OE-MRI scans with either nasal cannula or facial mask to breathe air and oxygen throughout.

Following this initial pilot, OE-MRI will be tested in 30 patients with solid head and neck tumours.

Diagnostic Test: MRI scan
Additional imaging using MRI scan




Primary Outcome Measures :
  1. Assessment of hypoxia in head and neck squamous cell cancer using oxygen enhanced Magnetic resonance imaging (using a range of different MR sequences) [ Time Frame: 3 years ]
    Assessment of hypoxia in head and neck squamous cell cancer using oxygen enhanced Magnetic resonance imaging (using a range of different MR sequences)


Secondary Outcome Measures :
  1. Optimal MRI sequence to image participants with head and neck cancer, based on tumour and organ at risk visualisation. [ Time Frame: 3 years ]
    Optimal MRI sequence to image participants with head and neck cancer, based on tumour and organ at risk visualisation.

  2. Treatment response in a number of participants with head and neck cancer treated with radiotherapy +/- systemic therapy [ Time Frame: 3 years ]
    Treatment response in a number of participants with head and neck cancer treated with radiotherapy +/- systemic therapy

  3. Treatment related toxicities in a number of participants with head and neck cancer as assessed during and after treatment completion [ Time Frame: 3 years ]
    Treatment related toxicities in a number of participants with head and neck cancer as assessed during and after treatment completion

  4. Survival outcomes in a number of participants treated with radiotherapy +/- systemic therapy for head and neck cancer [ Time Frame: 3 years ]
    Survival outcomes in a number of participants treated with radiotherapy +/- systemic therapy for head and neck cancer



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Aged 18 or over
  2. Able to receive and understand verbal and written information regarding the study and given written informed consent
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  4. Adequate renal function: Calculated creatinine clearance (Cockcroft-Gault) ≥30mL/min
  5. Be able to lie comfortably on back for up to 1 hour
  6. Be able to tolerate a thermoplastic shell
  7. Female patients must meet one of the following criteria:

    i. Postmenopausal for a minimum of one year ii. Surgically sterile iii. Not pregnant, confirmed by B-HCG blood test. iv. Not breastfeeding

  8. Cohort A (healthy participants): Up to 10 will be recruited to validate the use of nasal cannula
  9. Cohort B (patients): Any patient with HNSCC who is due to start definitive radiotherapy +/- chemotherapy. Up to 30 will be recruited. Each patient prior to recruitment will undergo a diagnostic biopsy at their local hospital as standard of care. The formalin fixed paraffin embedded (FFPE) tumour biopsy sample blocks will be requested from each site and stored in the Manchester Cancer Research Centre (MRCR) and tested for a multi-gene signature.

Exclusion Criteria:

Healthy volunteers or patients with any contraindications to MRI scanning (i.e heart valve replacement, pacemaker, metal implants not approved for MRI, neurostimulators), history of contrast (Gadolinium) allergy or pregnancy.


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): NCT03646747


Contacts
Contact: Sally Falk 0044 161 446 8318 ext 8318 sally.falk@christie.nhs.uk
Contact: Christina Hague 0044 161 446 8318 ext 8318 christina.hague@christie.nhs.uk

Sponsors and Collaborators
Sally Falk
University of Manchester
Investigators
Principal Investigator: James O'Connor University of Manchester

Responsible Party: Sally Falk, Research Project Manager, The Christie NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03646747     History of Changes
Other Study ID Numbers: 18_RADIO_133
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sally Falk, The Christie NHS Foundation Trust:
head and neck
radiotherapy
magnetic resonance imaging

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms