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Completed

NCT Number: NCT03523130

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imaging

Diagnostic Test

Macrophage-specific inflammation

Primary outcomes

  1. Aortic uptake of intravenously administered 99mTc tilmanocept on SPECT/CT

    Time frame: within 6 weeks of screening visit

Secondary outcomes

  1. Aortic plaque burden and morphology on CT angiography

    Time frame: within 6 weeks of screening visit

    Aortic plaque burden and morphology will be assessed through measurement of total, calcified, and non-calcified aortic plaque volume (mm3).

  2. Traditional markers of cardiovascular disease (CVD) risk in relation to cardiovascular imaging outcomes

    Time frame: within 6 weeks of screening visit

    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.

  3. Inflammatory markers in relation to cardiovascular imaging outcomes

    Time frame: within 6 weeks of screening visit

    The following inflammatory markers will be evaluated: soluble CD163 (ng/ml) , soluble CD 14 (ng/ml) , and Lp-PLA2 (ng/ml).

  4. Imaging assessments of the coronary vasculature

    Time frame: within 6 weeks of screening visit

    Cardiac CT angiography will be used to assess the coronary vasculature. Total, calcified, and non-calcified coronary plaque volume (mm3) will be measured.

  5. Comparison of imaging assessments between HIV-infected participants and non-HIV-infected participants

    Time frame: within 6 weeks of screening visit

    We will compare the standardized uptake values on SPECT/CT of HIV-infected participants and non-HIV-infected participants.

  6. Uptake of intravenously administered 99mTc tilmanocept on SPECT/CT in regions other than the aorta

    Time frame: within 6 weeks of screening visit

    Uptake of tilmanocept on SPECT/CT will determined by calculating a standardized uptake value.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 14, 2018
Registry last updated
Feb 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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