64Cu-DOTATATE PET-CT-skanning and Infective Endocarditis.

NCT05432427 | Completed DMC

• 1 other identifier: H-21040764
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that the 64Cu-DOTATATE will show uptake in the infected vegetations on the prosthetic heart valves and increase the accuracy of the right diagnosis - thus increasing the sensitivity and specificity compared to 18F-FDG PET/CT

Conditions

Endocarditis; Endocarditis;Chronic; Endocarditis Acute

Outcome Measures

Primary Outcomes (1)

• The number(percentege) of agreement between the two scan modalities in overall population

  x

  2 year

Secondary Outcomes (1)

• Compare the number of agreement in the uptake between the two scan modalities in infected patients versus newly operated patients

  2 year

Study Arms (1)

Group A, B, C, D, E, F, G

EXPERIMENTAL

Scans

Radiation: 64Cu-DOTATATE and 18F-FDG

Interventions

64Cu-DOTATATE and 18F-FDG RADIATION

All participants will get a 64Cu-DOTATATE-PET and 18F-FDG-PET/CT.

Group A, B, C, D, E, F, G

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Be able to understand given information and sign informered consent
• Group A: native heart valves without clinical or paraclinical sign of infection
• Group B: native heart valves with verified endocarditis (according to modified Duke-criteria)
• Group C: prothethic heart valves(mechanical or biological) without clinical or paraclinical sign of infection and more \>1 year sind the heart operation
• Group D: infected prothethic heart valves, in addition clinical and paraclinical signs of infection (blood cultures and samples) and echocardiography
• Group E: newly operated in the heart valves without infection (6 months since operation)
• Group F: newly heart valve operation due to endocarditis (6 monts since operation)
• Group G: chronical infection in the aortic valce - lifelong antibiotics.

You may not qualify if:

• allergi for 64Cu-DOTATATE or 18-FDG
• obesity(weight over 140 kg)
• critically ill, and PET scan not possible
• Pregnancy or suspected pregnancy - negativ hCG will be required for fertile women
• severe claustrophobia
• diabetes - defined by farmacological treatment
• recent heart operation(\<4 weeks)

Sponsors & Collaborators

• Emil Loldrup Fosbol: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

Location

MeSH Terms

Conditions

Endocarditis

Interventions

64Cu-DOTATATE; Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Emil L Fosbøl, MD,Ph.d.

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician, ph.d.

Model Details: Controlled prospectiv cohort study. Patients in the trial get a 64Cu-DOTATATEPET/ CT and/or 18F-FDG-PET/CT

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 27, 2022
• Study Start: April 28, 2022
• Primary Completion: September 29, 2023
• Study Completion: September 29, 2023
• Last Updated: December 27, 2024

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)