Use of 99mTc Tilmanocept for Imaging Arterial Inflammation

NCT02542371 | Completed

• 1 other identifier: 2014P001832
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

HIV

Keywords

HIV; Atherosclerosis; Tilmanocept

Outcome Measures

Primary Outcomes (1)

• Aortic 99mTc-Tilmanocept uptake on SPECT/CT scanning in HIV Patients

  within 6 weeks of screening visit

Secondary Outcomes (5)

• 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

Study Arms (4)

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

Interventions

Arterial Imaging OTHER

HIV infected with known subclinical atherosclerosis; HIV infected without known subclinical atherosclerosis; Non-HIV infected with known subclinical atherosclerosis; Non-HIV infected without known subclinical atherosclerosis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-infected subjects and HIV non-infected subjects

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Navidea Biopharmaceuticals: collaborator
• Havard University Center for AIDS Research: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• 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.

  PMID: 35856671 DERIVED

• 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.

  PMID: 28204544 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, plasma and serum

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Steven Grinspoon, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: September 7, 2015
• Study Start: September 1, 2015
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-04

Locations

US (1)