NCT02497586

Brief Summary

Lung cancer is commonly characterised either with a surgical procedure or by taking a tissue sample with a needle. Unfortunately, these invasive approaches may be unsafe in many patients with lung cancer, who often have co-existing illnesses such as emphysema. Magnetic resonance spectroscopy (MRS) is a type of scan which offers the possibility of assessing tumour function by measuring concentrations of chemicals (metabolites) within the abnormal tissue. It is a well-established technique in imaging brain cancers. It has also been more recently studied in assessing prostate, liver and heart. There has been very little exploration of the potential role of MRS in lung cancer. The proposed feasibility study will recruit 15 patients with proven lung cancer to undergo an MRS scan. The reliability of the technique for metabolite measurement will be determined by comparing repeated scans from the same region in the same tumour. Further scans from different regions in the same tumour, normal lung around the tumour and tumour regions in different patients will be used to look for any patterns in the cancer metabolites which may indicate avenues for potential future research.

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
15

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable lung-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

June 15, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
18 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 14, 2015

Status Verified

July 1, 2015

Enrollment Period

11 months

First QC Date

June 15, 2015

Last Update Submit

July 10, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Presence of metabolite peaks

    Presence of metabolite peaks in MR spectra obtained from lung tumours using a 3T MR system.

    Data collected on day 1

Secondary Outcomes (2)

  • Reproducability of metabolite peaks

    Data collected on day 1

  • Metabolite peak-clinical parameter colleration

    Data collected on day 1

Study Arms (1)

MRS

EXPERIMENTAL

Magnetic resonance spectroscopy (MRS) is a type of scan which offers the possibility of assessing tumour function by measuring concentrations of chemicals (metabolites) within the abnormal tissue. This is a prospective feasibility study, aiming to recruit 15 consecutive patients with lung cancer to undergo proton MRS. The feasibility and repeatability of the technique will be assessed by analysis of the MR spectra obtained.

Radiation: Magnetic resonance spectroscopy

Interventions

Magnetic resonance spectroscopy (MRS) is a type of scan which offers the possibility of assessing tumour function by measuring concentrations of chemicals (metabolites) within the abnormal tissue. It is a well-established technique in imaging brain cancers.

MRS

Eligibility Criteria

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

You may qualify if:

  • biopsy-confirmed small cell or non-small cell lung cancer
  • solid intrapulmonary tumour of at least 3 cm in long and short axis diameters on transverse CT images
  • ECOG performance status ≤ 2
  • able to provide written informed consent and respond appropriately to verbal instructions for scan acquisition
  • age 18 years or older

You may not qualify if:

  • chemotherapy within the preceding 12 months
  • previous radiotherapy to the tumour
  • cardiac pacemaker/defibrillator, internal pacing wires, cerebral aneurysm clip, incompatible metallic heart valve replacements, other incompatible implants/prostheses, claustrophobia or other MRI contraindication
  • history of metal entering the body or eye, unless residual metal in the affected area likely to cause harm has been adequately excluded by X-ray in the opinion of Dr Cowell or Dr Stobo
  • intractable cough, inability to lie flat or other impediment to acquisition of breath-held MR images
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Castillo M, Kwock L, Mukherji SK. Clinical applications of proton MR spectroscopy. AJNR Am J Neuroradiol. 1996 Jan;17(1):1-15. No abstract available.

    PMID: 8770242BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • David B Stobo, Dr

    NHS Greater Glasgow and Clyde

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2015

First Posted

July 14, 2015

Study Start

August 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 14, 2015

Record last verified: 2015-07