Application of IV 99mTc-tilmanocept for Imaging of Macrophage-specific Inflammation

HIV Clinical Trial

Official title:

Application of IV 99mTc-tilmanocept for Imaging of Macrophage-specific Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03523130
• Other study ID #: 2018P000146
• Status: Completed
• Start date: May 3, 2018
• Est. completion date: October 30, 2020

Study information

• Verified date: February 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate uptake of intravenously administered 99mTc-tilmanocept using single photon emission computed tomography (SPECT/CT) scanning in individuals with HIV and individuals without HIV.

Description:

People living with HIV (PLWH) have an increased risk of cardiovascular disease (CVD) compared to individuals without HIV. Increased systemic immune activation and arterial inflammation are thought to contribute to this increased risk by affecting the highly inflammatory process of atherosclerotic plaque formation and progression. This study will evaluate whether intravenous administration of a macrophage-specific imaging agent, 99mTc-tilmanocept, followed by SPECT/CT scanning can permit quantification of aortic 99mTc-tilmanocept uptake, reflective of aortic macrophage-specific inflammation among participants with HIV. We will also compare aortic 99mTc-tilmanocept uptake in participants with HIV to participants without HIV. Immunology parameters such as markers of immune activation and traditional CVD parameters will be assessed in relation to imaging assessments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

HIV-infected participants:

Inclusion Criteria:

• men and women, ages 18 to 80, with documented HIV infection
• current use of antiretroviral therapy (ART), with no changes to regimen within last 3 months

Exclusion Criteria:

• pregnancy or breastfeeding
• known active opportunistic infection requiring ongoing medical therapy (not including Hepatitis B/C)
• CD4 count < 50 cells/mm3
• history of myocardial infarction,acute coronary syndrome, or coronary artery stenting or surgery
• stable or unstable angina
• recent and/or current treatment with prescription, systemic steroids or anti-inflammatory/immune suppressant medical therapies
• current use of statin or use of statin for > 1 month within the last 6 months
• known allergy to dextrans and/or DTPA and/or radiometals
• eGFR < 60 ml/min/1.73 m2 calculated by CKD-EPI
• known severe allergy to iodinated contrast media
• contraindication to nitroglycerin
• significant radiation exposure (>2 CT angiograms) received within the past 12 months
• reported active illicit drug use
• concurrent enrollment in another research study judged by the study investigators to interfere with the current study Non-HIV-infected participant: Inclusion criteria: -men and women, ages 18 to 80, without HIV infection

Exclusion Criteria:

• pregnancy or breastfeeding
• history of myocardial infarction, acute coronary syndrome, or coronary artery stenting or surgery
• stable or unstable angina
• recent and/or current treatment with prescription, systemic steroids or anti-inflammatory/immune suppressant medical therapies
• current use of statin or use of statin for > 1 month within the last 6 months
• known allergy to dextrans and/or DTPA and/or radiometals
• eGFR < 60 ml/min/1.73 m2 calculated by CKD-EPI
• known severe allergy to iodinated contrast media
• contraindication to nitroglycerin
• significant radiation exposure (>2 CT angiograms) received within the past 12 months
• reported active illicit drug use
• concurrent enrollment in another research study judged by the study investigators to interfere with the current study

Related Conditions & MeSH terms

• HIV
• Inflammation

Intervention

Diagnostic Test:
• Imaging
Macrophage-specific inflammation

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aortic uptake of intravenously administered 99mTc tilmanocept on SPECT/CT		within 6 weeks of screening visit
Secondary	Aortic plaque burden and morphology on CT angiography	Aortic plaque burden and morphology will be assessed through measurement of total, calcified, and non-calcified aortic plaque volume (mm3).	within 6 weeks of screening visit
Secondary	Traditional markers of cardiovascular disease (CVD) risk in relation to cardiovascular imaging outcomes	We will calculate a risk score of future CVD risk (%) which will take into account traditional markers of CVD risk such as blood pressure, lipid levels, and age.	within 6 weeks of screening visit
Secondary	Inflammatory markers in relation to cardiovascular imaging outcomes	The following inflammatory markers will be evaluated: soluble CD163 (ng/ml) , soluble CD 14 (ng/ml) , and Lp-PLA2 (ng/ml).	within 6 weeks of screening visit
Secondary	Imaging assessments of the coronary vasculature	Cardiac CT angiography will be used to assess the coronary vasculature. Total, calcified, and non-calcified coronary plaque volume (mm3) will be measured.	within 6 weeks of screening visit
Secondary	Comparison of imaging assessments between HIV-infected participants and non-HIV-infected participants	We will compare the standardized uptake values on SPECT/CT of HIV-infected participants and non-HIV-infected participants.	within 6 weeks of screening visit
Secondary	Uptake of intravenously administered 99mTc tilmanocept on SPECT/CT in regions other than the aorta	Uptake of tilmanocept on SPECT/CT will determined by calculating a standardized uptake value.	within 6 weeks of screening visit