NCT02812849

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

June 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2020

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

3.4 years

First QC Date

June 22, 2016

Last Update Submit

October 12, 2020

Conditions

Cardiac Sarcoidosis

Outcome Measures

Primary Outcomes (2)

  • Sensitivity to detect cardiac sarcoidosis

    1 day at PET/CT examination

  • Specificity to detect cardiac sarcoidosis

    1 day at PET/CT examination

Study Arms (3)

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

Cu-64 DOTATATEDRUG
Known cardiac sarcoidosisOther inflammatory cardiac diseaseSuspected cardiac sarcoidosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Infection Pregnancy Severe claustrophobia Weight \>140 kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Interventions

copper dotatate CU-64

Study Officials

  • Rasmus S Ripa, MD, DMSc

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, DMSc

Study Record Dates

First Submitted

June 22, 2016

First Posted

June 24, 2016

Study Start

June 1, 2016

Primary Completion

November 1, 2019

Study Completion

February 27, 2020

Last Updated

October 14, 2020

Record last verified: 2020-10

Locations

DK(1)