NCT03646747

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable head-and-neck-cancer

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

First Submitted

Initial submission to the registry

May 3, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

August 24, 2018

Status Verified

August 1, 2018

Enrollment Period

3.3 years

First QC Date

May 3, 2018

Last Update Submit

August 23, 2018

Conditions

Head and Neck Cancer

Keywords

head and neckradiotherapymagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • Assessment of hypoxia in head and neck squamous cell cancer using oxygen enhanced Magnetic resonance imaging (using a range of different MR sequences)

    Assessment of hypoxia in head and neck squamous cell cancer using oxygen enhanced Magnetic resonance imaging (using a range of different MR sequences)

    3 years

Secondary Outcomes (4)

  • Optimal MRI sequence to image participants with head and neck cancer, based on tumour and organ at risk visualisation.

    3 years

  • Treatment response in a number of participants with head and neck cancer treated with radiotherapy +/- systemic therapy

    3 years

  • Treatment related toxicities in a number of participants with head and neck cancer as assessed during and after treatment completion

    3 years

  • Survival outcomes in a number of participants treated with radiotherapy +/- systemic therapy for head and neck cancer

    3 years

Study Arms (1)

MRI scan

EXPERIMENTAL

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

Interventions

MRI scanDIAGNOSTIC_TEST

Additional imaging using MRI scan

MRI scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 or over
  • Able to receive and understand verbal and written information regarding the study and given written informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate renal function: Calculated creatinine clearance (Cockcroft-Gault) ≥30mL/min
  • Be able to lie comfortably on back for up to 1 hour
  • Be able to tolerate a thermoplastic shell
  • 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
  • Cohort A (healthy participants): Up to 10 will be recruited to validate the use of nasal cannula
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • James O'Connor

    University of Manchester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sally Falk

CONTACT

0044 161 446 8318sally.falk@christie.nhs.uk

Christina Hague

CONTACT

0044 161 446 8318christina.hague@christie.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Single site, non-randomised basic science study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Project Manager

Study Record Dates

First Submitted

May 3, 2018

First Posted

August 24, 2018

Study Start

September 1, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

August 24, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share