Use of 99mTc Tilmanocept for Imaging Arterial Inflammation
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| HIV infected with known subclinical atherosclerosis
|
Other: Arterial Imaging
|
| HIV infected without known subclinical atherosclerosis
|
Other: Arterial Imaging
|
| Non-HIV infected with known subclinical atherosclerosis
|
Other: Arterial Imaging
|
| Non-HIV infected without known subclinical atherosclerosis
|
Other: Arterial Imaging
|
Outcome Measures
Primary Outcome Measures
- Aortic 99mTc-Tilmanocept uptake on SPECT/CT scanning in HIV Patients [within 6 weeks of screening visit]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts General Hospital
- Navidea Biopharmaceuticals
- Havard University Center for AIDS Research
Investigators
- Principal Investigator: Steven Grinspoon, M.D., Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2014P001832