Somatostatin Receptor Imaging in Cardiac Sarcoidosis | NCT02812849

Studies
Somatostatin Receptor Imaging in Cardiac Sarcoidosis

NCT02812849

Sponsor

Rigshospitalet, Denmark

Status

Withdrawn

Last Update Posted

Oct 14, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Cardiac Sarcoidosis

Interventions

Cu-64 DOTATATE

Countries

Denmark

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

Oct 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Logistic reasons

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Nov 2019Estimated

Completion Date

Feb 27, 2020Actual

First Submitted Date

Jun 22, 2016

First Submission Date that Met QC Criteria

Jun 23, 2016

First Posted Date

Jun 24, 2016Estimated

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

Oct 12, 2020

Last Update Posted Date

Oct 14, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of the trial is to determine the accuracy of Cu-64 labelled DOTATATE for diagnosing cardiac sarcoidosis using PET/CT or PET/MRI.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Suspected cardiac sarcoidosis	Cu-64 DOTATATE PET/CT or PET/MRI	Drug: Cu-64 DOTATATE
Known cardiac sarcoidosis	Cu-64 DOTATATE PET/CT or PET/MRI	Drug: Cu-64 DOTATATE
Other inflammatory cardiac disease	Cu-64 DOTATATE PET/CT or PET/MRI	Drug: Cu-64 DOTATATE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cu-64 DOTATATE	Drug		Known cardiac sarcoidosis Other inflammatory cardiac disease Suspected cardiac sarcoidosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity to detect cardiac sarcoidosis		1 day at PET/CT examination
Specificity to detect cardiac sarcoidosis		1 day at PET/CT examination

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Group A: Suspected cardiac sarcoidosis Group B: Known cardiac sarcoidosis, clinical follow-up Group C: Myocarditis or dilated cardiomyopathy (Non-cardiac sarcoidosis)

Exclusion Criteria:

Infection Pregnancy Severe claustrophobia Weight >140 kg

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with suspected or known cardiac sarcoidosis or with myocarditis/dilated cardiomyopathy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rasmus S Ripa, MD, DMSc	Rigshospitalet, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet		Copenhagen			Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000718307	copper dotatate CU-64

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided