Regional Lung Imaging Using Hyperpolarized Xenon Gas

NCT02112929 | Completed Phase 1

• 2 other identifiers: HPX-2011-0012011-002027-17
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to use hyperpolarized xenon gas magnetic resonance imaging (MRI) and computed tomography to develop a new technique capable of objectively and quantitatively describing regional and structural lung abnormality. Since this is a relatively novel technique, the investigators first need to acquire imaging and clinical data from a group of participants with normal lungs. The investigators hope to generate an "atlas" of normality, which will form the foundation of future studies to compare with patients suffering from chronic respiratory disease. The investigators also aim to validate the new technique in terms of intra-subject reproducibility.

Conditions

Lung Disease

Keywords

Magnetic Resonance Imaging; Lung Diseases

Outcome Measures

Primary Outcomes (1)

• Imaging parameters from MRI scan after inhalation of hyperpolarized xenon gas

  Maps of Apparent Diffusion Coefficient and objective measures of regional lung Production of Xe-129 ADC maps co-registered to CT and objective measures of regional lung anatomy, ventilation and perfusion in normals with hyperpolarized Xe-129 MR imaging (ADC quantification in cm2s-1). Derivation of reproducibility data

  Up to one year after first scan

Secondary Outcomes (2)

• To produce and confirm reliability of maps to show regional blood perfusion in the lung area

  On entry to the study and one year later

• Repeatability of the 129-Xe MR scans

  On study entry and one year later

Study Arms (1)

Inhalation of hyperpolarized xenon

EXPERIMENTAL

One litre of hyperpolarized xenon to be inhaled during MRI scan of the lungs

Drug: Hyperpolarized xenon

Interventions

Hyperpolarized xenon DRUG

Inhalation of up to one litre of polarized xenon gas, up to four inhalations per day are permitted.

Inhalation of hyperpolarized xenon

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Male, aged \> 18 years.
• Patients with previous histologically verified testicular germ cell tumour who have successfully undergone resection and do not and have never had metastatic disease.
• Normal chest CT, confirmed subjectively by a Consultant Thoracic radiologist (Dr F. Gleeson or R. Benamore or their nominated representative), and no evidence of emphysema on CT density mapping to have been performed no more than one year prior to proposed hyperpolarized Xe-129 MR scan.
• Normal spirometry indices (\>80% predicted FEV1 \[forced expiratory volume in one second\]for age and height) and normal arterial oxygen saturations (SaO2), normal carbon monoxide transfer factor, and generally in good health with no subjective exercise limitation.
• Current non-smokers with no significant smoking history (≤10 pack years) and no history of respiratory disease.
• WHO performance status 0.
• Able (in the Investigators opinion) and willing to comply with all study requirements.
• Willing to allow his General Practitioner and consultant, if appropriate, to be notified of participation in the study.

You may not qualify if:

• Inability to give written informed consent.
• Patients with a history of nodal or metastatic germ cell tumour.
• Patients with a prior history of chemotherapy or radiotherapy at study entry.
• Prior history of thoracic surgery or significant chest trauma
• Prior history of significant smoking or respiratory disease.
• The presence of another malignancy, where the extent of disease or treatment for that condition may interfere with the study endpoints.
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
• Inability to lie flat for imaging.
• Contra-indications to receiving iodine-based contrast during thoracic CT - those with marked renal failure not on dialysis, known allergy to contrast medium, history of anaphylaxis, known or suspected thyroid carcinoma and inability to gain intra-venous access.
• Contraindications to MRI examination including indwelling pacemaker, non-MRI compatible metallic implant, severe claustrophobia, intra-ocular foreign body.
• Epilepsy requiring on-going medical treatment, or a seizure within the past year.

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead
• National Institute for Health Research, United Kingdom: collaborator
• University of Sheffield: collaborator

Study Sites (1)

Oxford University Hospitals NHS Trust

Oxford, England, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Fergus V Gleeson

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: April 14, 2014
• Study Start: April 1, 2012
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: February 23, 2022

Record last verified: 2021-10

Locations

GB (1)