Clinical trial · Interventional

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

NCT03646747CI-TRIAL-00034561unknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Head and Neck Cancer	Malignant Head and Neck Neoplasm	ALIAS	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
MRI scan	Diagnostic Test	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
MRI scan
description
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.
interventionNames
1. Diagnostic Test: MRI scan

Primary outcomes (1)

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

Secondary outcomes (4)

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

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.