NCT02988531

Brief Summary

To determine whether PET-MRI can obtain comparable images to PET-CT in those with coronary artery disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 23, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 9, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

February 9, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2017

Completed
Last Updated

May 21, 2024

Status Verified

October 1, 2017

Enrollment Period

10 months

First QC Date

September 23, 2016

Last Update Submit

May 20, 2024

Conditions

MRIPET ScanPositron-Emission TomographyCardiovascular DiseaseCoronary Artery DiseaseMagnetic Resonance Imaging

Keywords

PETMRIAttenuationCorrectionCardiovascularcoronarydisease

Outcome Measures

Primary Outcomes (1)

  • The standard uptake values (SUV's) of volumes of interest (VOI's) on corresponding PET-CT and PET-MR images will be evaluated by expert. The distribution of PET positive VOI's will be compared using a cut-off of 1.6 for tissue to background ratio (TBR).

    7 months

Secondary Outcomes (1)

  • Standard breath-held MR-based attenuation correction will be compared to a novel free-breathing approach. Impact on PET image artifacts and the interpretation of vascular uptake will be evaluated semi-quantitatively by expert readers.

    7 months

Study Arms (1)

PET/MR

EXPERIMENTAL

Participants to have PET/MR scan

Other: PET/MR scan

Interventions

PET/MR scanOTHER

Patients to undergo PET/MR scanning after PET/CT scan. Patients will have had an injection of 18F Sodium Fluoride for their PET/CT therefore will not need another dose of radiotracer prior to their PET/MR scan.

PET/MR

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing thoracic PET-CT scans (this can include NHS and patients enrolled in other research studies)
  • Aged over 50 years old. No upper age limit
  • Provision of informed consent prior to any study specific procedures

You may not qualify if:

  • Inability or unwilling to give informed consent.
  • Major intercurrent illness with life-expectancy \<2 years.
  • Contra-indication to Magnetic resonance imaging.
  • Permanent or persistent atrial fibrillation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Edinburgh

Edinburgh, Lothian, EH16 4SB, United Kingdom

Location

Related Publications (3)

  • Dweck MR, Chow MW, Joshi NV, Williams MC, Jones C, Fletcher AM, Richardson H, White A, McKillop G, van Beek EJ, Boon NA, Rudd JH, Newby DE. Coronary arterial 18F-sodium fluoride uptake: a novel marker of plaque biology. J Am Coll Cardiol. 2012 Apr 24;59(17):1539-48. doi: 10.1016/j.jacc.2011.12.037.

    PMID: 22516444BACKGROUND

  • Dweck MR, Khaw HJ, Sng GK, Luo EL, Baird A, Williams MC, Makiello P, Mirsadraee S, Joshi NV, van Beek EJ, Boon NA, Rudd JH, Newby DE. Aortic stenosis, atherosclerosis, and skeletal bone: is there a common link with calcification and inflammation? Eur Heart J. 2013 Jun;34(21):1567-74. doi: 10.1093/eurheartj/eht034. Epub 2013 Feb 7.

    PMID: 23391586BACKGROUND

  • Joshi NV, Vesey AT, Williams MC, Shah AS, Calvert PA, Craighead FH, Yeoh SE, Wallace W, Salter D, Fletcher AM, van Beek EJ, Flapan AD, Uren NG, Behan MW, Cruden NL, Mills NL, Fox KA, Rudd JH, Dweck MR, Newby DE. 18F-fluoride positron emission tomography for identification of ruptured and high-risk coronary atherosclerotic plaques: a prospective clinical trial. Lancet. 2014 Feb 22;383(9918):705-13. doi: 10.1016/S0140-6736(13)61754-7. Epub 2013 Nov 11.

    PMID: 24224999BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary Artery DiseaseDisease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

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

September 23, 2016

First Posted

December 9, 2016

Study Start

February 9, 2017

Primary Completion

December 7, 2017

Study Completion

December 7, 2017

Last Updated

May 21, 2024

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

No plans to share patient specific data

Locations

GB(1)