Use of 99mTc Tilmanocept for Imaging Arterial Inflammation

Completed

• Conditions: HIV
• Interventions: Other: Arterial Imaging

• Registration Number: NCT02542371
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The purpose of this study is to measure arterial 99mTc-Tilmanocept uptake using single photon emission computed tomography (SPECT/CT) scanning in HIV infected subjects known to have subclinical coronary atherosclerosis as assessed by contrast-enhanced coronary computed tomography angiography (CCTA).

Detailed Description

Detailed Description:

Patients with HIV have been shown to have increased atherosclerotic risk compared to age-matched controls, and this risk is thought to be related to increased systemic immune activation. Specifically, systemic immune activation may contribute to destabilizing coronary atherosclerotic plaque, leading to plaque rupture and myocardial infarction. This study is intended to measure arterial uptake of the macrophage specific marker 99mTc-Tilmanocept using single photon emission computed tomography, applied initially to a group of HIV-infected patients with known subclinical coronary atherosclerosis on CCTA. Moreover, traditional markers of CVD risk and inflammatory markers will be assessed in relation to CV imaging outcomes. Positive findings in the index HIV group with known subclinical atherosclerosis will prompt subsequent study of three comparison groups, as above.

Study Timeline

• Study First Submitted: 2015-08-26
• Study Start: 2015-09
• Study First Submitted QC: 2015-09-04
• Study First Posted: 2015-09-07
• Primary Completion: 2021-08
• Study Completion: 2021-08
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-HIV infected with known subclinical atherosclerosis	Arterial Imaging	-
HIV infected with known subclinical atherosclerosis	Arterial Imaging	-
HIV infected without known subclinical atherosclerosis	Arterial Imaging	-
Non-HIV infected without known subclinical atherosclerosis	Arterial Imaging	-

Primary Outcome Measures

Name	Time	Method
Aortic 99mTc-Tilmanocept uptake on SPECT/CT scanning in HIV Patients	within 6 weeks of screening visit

Secondary Outcome Measures

Name	Time	Method
Aortic plaque burden and morphology on CCTA in HIV Patients	within 6 weeks of screening visit
Traditional markers of cardiovascular disease (CVD) risk and inflammatory markers in relation to cardiovascular imaging outcomes	within 6 weeks of screening visit
Imaging assessments in the coronary vasculature in HIV patients	within 6 weeks of screening visit
Comparison of imaging assessments b/ HIV patients w/ known subclinical atherosclerosis, HIV patients w/o known subclinical atherosclerosis, non HIV patients w/ known subclinical atherosclerosis and non HIV patients w/o known subclinical atherosclerosis	within 6 weeks of screening visit
99mTc-Tilmanocept uptake on SPECT/CT in regions other than the aorta	within 6 weeks of screening visit

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States