Use of 99mTc Tilmanocept for Imaging Arterial Inflammation
NCT ID: NCT02542371
Last Updated: 2022-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2015-09-30
2021-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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HIV infected with known subclinical atherosclerosis
Arterial Imaging
HIV infected without known subclinical atherosclerosis
Arterial Imaging
Non-HIV infected with known subclinical atherosclerosis
Arterial Imaging
Non-HIV infected without known subclinical atherosclerosis
Arterial Imaging
Interventions
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Arterial Imaging
Eligibility Criteria
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Inclusion Criteria
* current use of antiretroviral therapy (ART), with no changes to regimen within last 3 months
* history of subclinical atherosclerosis on CCTA
* 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
* men and women, ages 18+, without documented HIV infection
* history of subclinical atherosclerosis on CCTA
* men and women, ages 18+, without documented HIV infection
* history of clean aorta/coronaries on CCTA
Exclusion Criteria
* 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:
HIV negative subjects with known subclinical atherosclerosis:
* 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:
18 Years
80 Years
ALL
Yes
Sponsors
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Navidea Biopharmaceuticals
INDUSTRY
Havard University Center for AIDS Research
UNKNOWN
Massachusetts General Hospital
OTHER
Responsible Party
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Steven K. Grinspoon, MD
Professor of Medicine
Principal Investigators
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Steven Grinspoon, M.D.
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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Toribio M, Wilks MQ, Hedgire S, Lu MT, Cetlin M, Wang M, Alhallak I, Durbin CG, White KS, Wallis Z, Schnittman SR, Stanley TL, El-Fakhri G, Lee H, Autissier P, Zanni MV, Williams KC, Grinspoon SK. Increased Macrophage-Specific Arterial Infiltration Relates to Noncalcified Plaque and Systemic Immune Activation in People With Human Immunodeficiency Virus. J Infect Dis. 2022 Nov 11;226(10):1823-1833. doi: 10.1093/infdis/jiac301.
Zanni MV, Toribio M, Wilks MQ, Lu MT, Burdo TH, Walker J, Autissier P, Foldyna B, Stone L, Martin A, Cope F, Abbruzzese B, Brady T, Hoffmann U, Williams KC, El-Fakhri G, Grinspoon SK. Application of a Novel CD206+ Macrophage-Specific Arterial Imaging Strategy in HIV-Infected Individuals. J Infect Dis. 2017 Apr 15;215(8):1264-1269. doi: 10.1093/infdis/jix095.
Other Identifiers
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2014P001832
Identifier Type: -
Identifier Source: org_study_id
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