PET/MR Imaging In Patients With Cardiac Sarcoidosis | NCT03705884

Studies
PET/MR Imaging In Patients With Cardiac Sarcoidosis

NCT03705884

Sponsor

University of Edinburgh

Status

Completed

Last Update Posted

May 17, 2024Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Cardiac Sarcoidosis

Interventions

18F-FDG
Prednisolone

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 30, 2017Actual

Primary Completion Date

Dec 1, 2018Actual

Completion Date

Dec 1, 2018Actual

First Submitted Date

Aug 8, 2018

First Submission Date that Met QC Criteria

Oct 12, 2018

First Posted Date

Oct 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2024

Last Update Posted Date

May 17, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

PET scanning (positron emission tomography) is a well-established technique used to identify areas of interest within the body. It involves injecting a radioactive tracer which highlights abnormal areas. It has recently been combined with CT (computed tomography) and MRI (magnetic resonance imaging) scanning to more accurately identify abnormalities within the heart. Cardiac sarcoidosis, a condition which causes scarring and inflammation within the heart muscle, is of particular interest.

The study makes use of hybrid PET/MR scanning using a designated scanner which enables PET scanning combined with MRI scanning. This will allow imaging of abnormal areas within the heart in this condition alongside treatment regimens in a way which hasn't been done before. If successful, this imaging method will play a key role in diagnosing, quantifying and monitoring these conditions.

All participants will undergo PET scanning, where a radioactive tracer is injected into a vein before the scan. The radioactive substance only lasts for a short time and is safe, passed out of the body in urine. The scan will be performed twice; once before treatment and once after treatment has been established. A cohort of healthy volunteers will undergo scanning in exactly the same way to enable us to compare the results with hearts of people who don't have cardiac sarcoidosis.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cardiac Sarcoidosis	Other	Patients with an established diagnosis of cardiac sarcoidosis.	Other: 18F-FDG Drug: Prednisolone
Healthy volunteers	Other	Healthy volunteer subjects of similar age and gender to patient cohort.	Other: 18F-FDG Drug: Prednisolone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
18F-FDG	Other	Hybrid 18F-FDG PET/MR imaging for observational diagnostic purposes.	Cardiac Sarcoidosis Healthy volunteers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Myocardial 18F-FDG uptake	Quantification of myocardial PET tracer uptake before steroid therapy	Within 1 year
Myocardial 18F-FDG uptake	Quantification of myocardial PET tracer uptake after steroid therapy	Within 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cardiac Sarcoidosis Patients:

Aged over 40 years
Completion of informed consent
Established diagnosis of cardiac sarcoidosis
Established diagnosis as per HRS recommended diagnostic criteria

Healthy Volunteers:

Aged over 40
Completion of informed consent

Exclusion Criteria:

All participants:
Inability or unwilling to give informed consent
Women who are pregnant, breastfeeding or of child-bearing potential (women who have experienced menarche, are pre-menopausal and have not been sterilised) will not be enrolled into the trial.
Major intercurrent illness with life-expectancy <2 years.
Renal dysfunction (eGFR less than or equal to 30ml/min/1.73m2)
Adverse reaction or hypersensitivity to 18F-FDG PET tracer
NYHA Class IV heart failure
Patients with atrial fibrillation and poor rate control
Contraindications to MRI scanning
Previous history of contrast allergy of adverse reactions (Gadolinium-containing agents)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc R Dweck, MD PhD	University of Edinburgh	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen's Medical Research Institute		Edinburgh	Midlothian	EH16 4TJ	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019788	Fluorodeoxyglucose F18
D011239	Prednisolone

Ancestor Terms

ID	Term
D003847	Deoxyglucose
D003837	Deoxy Sugars
D002241	Carbohydrates
D011246	Pregnadienetriols

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

Patients and healthy subjects will be allocated in a non-randomised fashion to either corticosteroid or control arms, for parallel comparison within the two groups. The corticosteroid is recognised treatment for the condition and is being used to observe the impact on diagnostic imaging; no treatment effects are being studied or are endpoints of the study (i.e. the study is not a clinical trial of treatment in cardiac sarcoidosis with corticosteroid).