Use of 99mTc Tilmanocept for Imaging Arterial Inflammation

HIV Clinical Trial

Official title:

Use of 99mTc Tilmanocept for Imaging Arterial Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02542371
• Other study ID #: 2014P001832
• Status: Completed
• Start date: September 2015
• Est. completion date: August 2021

Study information

• Verified date: April 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

HIV infected subjects with known subclinical atherosclerosis:

Inclusion criteria:

• men and women, ages 18+, with documented HIV infection

• current use of antiretroviral therapy (ART), with no changes to regimen within last 3 months

• history of subclinical atherosclerosis on CCTA

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 angina, myocardial infarction, acute coronary syndrome, or coronary artery stenting or surgery

• 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 DPTA and/or radiometals and/or iodinated contrast media

• eGFR < 60 ml/min/1.73 m2 calculated by CDK-EPI

• contraindications to beta blockers or nitroglycerin

• significant radiation exposure (>2 CT angiograms) received within the past 12 months

• BMI > 35 kg/m2 or waist circumference > 70 cm (scanner limitations)

HIV infected subjects without known subclinical atherosclerosis:

Inclusion criteria:

• men and women, ages 18+, with documented HIV infection

• current use of antiretroviral therapy (ART), with no changes to regimen within last 3 months

• history of clean aorta/ coronaries on CCTA

Exclusion criteria:

• Same as exclusion criteria for HIV infected subjects with known subclinical atherosclerosis

HIV negative subjects with known subclinical atherosclerosis:

Inclusion criteria:

• men and women, ages 18+, without documented HIV infection

• history of subclinical atherosclerosis on CCTA

Exclusion criteria:

• pregnancy or breastfeeding

• history of angina, myocardial infarction, acute coronary syndrome, or coronary artery stenting or surgery

• 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 DPTA and/or radiometals and/or iodinated contrast media

• eGFR < 60 ml/min/1.73 m2 calculated by CDK-EPI

• contraindications to beta blockers or nitroglycerin

• significant radiation exposure (>2 CT angiograms) received within the past 12 months

• BMI > 35 kg/m2 or waist circumference > 70 cm (scanner limitations)

HIV negative subjects without known subclinical atherosclerosis:

Inclusion criteria:

• men and women, ages 18+, without documented HIV infection

• history of clean aorta/coronaries on CCTA

Exclusion criteria:

• Same as exclusion criteria for HIV negative subjects with known subclinical atherosclerosis

Related Conditions & MeSH terms

• Arteritis
• HIV
• Inflammation

Intervention

Other:
• Arterial Imaging

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Havard University Center for AIDS Research, Navidea Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aortic 99mTc-Tilmanocept uptake on SPECT/CT scanning in HIV Patients		within 6 weeks of screening visit
Secondary	Aortic plaque burden and morphology on CCTA in HIV Patients		within 6 weeks of screening visit
Secondary	Traditional markers of cardiovascular disease (CVD) risk and inflammatory markers in relation to cardiovascular imaging outcomes		within 6 weeks of screening visit
Secondary	Imaging assessments in the coronary vasculature in HIV patients		within 6 weeks of screening visit
Secondary	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
Secondary	99mTc-Tilmanocept uptake on SPECT/CT in regions other than the aorta		within 6 weeks of screening visit