Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03523130
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
HIV Diagnostic Test: Imaging

Detailed Description:
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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Application of IV 99mTc-tilmanocept for Imaging of Macrophage-specific Inflammation
Actual Study Start Date : May 3, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Tilmanocept

Group/Cohort Intervention/treatment
HIV-infected Diagnostic Test: Imaging
Macrophage-specific inflammation

non-HIV-infected Diagnostic Test: Imaging
Macrophage-specific inflammation




Primary Outcome Measures :
  1. Aortic uptake of intravenously administered 99mTc tilmanocept on SPECT/CT [ Time Frame: within 6 weeks of screening visit ]

Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
HIV-infected participants and non-HIV-infected participants
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523130


Contacts
Layout table for location contacts
Contact: Steven Grinspoon, MD 617-724-9109 sgrinspoon@mgh.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Steven K. Grinspoon, MD    617-724-9109    sgrinspoon@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Layout table for additonal information
Responsible Party: Steven K. Grinspoon, MD, Professor of Medicine, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03523130    
Other Study ID Numbers: 2018P000146
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Steven K. Grinspoon, MD, Massachusetts General Hospital:
Macrophage-specific inflammation
Arterial inflammation
Neuroinflammation
SPECT/CT
Tilmanocept
Additional relevant MeSH terms:
Layout table for MeSH terms
Inflammation
Pathologic Processes