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Use of 99mTc Tilmanocept for Imaging Arterial Inflammation

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ClinicalTrials.gov Identifier: NCT02542371
Recruitment Status : Completed
First Posted : September 7, 2015
Last Update Posted : April 6, 2022
Sponsor:
Collaborators:
Navidea Biopharmaceuticals
Havard University Center for AIDS Research
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital

Study Description
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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
HIV Other: Arterial Imaging

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
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Use of 99mTc Tilmanocept for Imaging Arterial Inflammation
Actual Study Start Date : September 2015
Actual Primary Completion Date : August 2021
Actual Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Tilmanocept

Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Aortic 99mTc-Tilmanocept uptake on SPECT/CT scanning in HIV Patients [ Time Frame: within 6 weeks of screening visit ]

Secondary Outcome Measures :
  1. Aortic plaque burden and morphology on CCTA in HIV Patients [ Time Frame: within 6 weeks of screening visit ]
  2. Traditional markers of cardiovascular disease (CVD) risk and inflammatory markers in relation to cardiovascular imaging outcomes [ Time Frame: within 6 weeks of screening visit ]
  3. Imaging assessments in the coronary vasculature in HIV patients [ Time Frame: within 6 weeks of screening visit ]
  4. 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 [ Time Frame: within 6 weeks of screening visit ]
  5. 99mTc-Tilmanocept uptake on SPECT/CT in regions other than the aorta [ Time Frame: within 6 weeks of screening visit ]

Biospecimen Retention:   Samples Without DNA
whole blood, plasma and serum

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
HIV-infected subjects and HIV non-infected subjects
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
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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): NCT02542371


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Navidea Biopharmaceuticals
Havard University Center for AIDS Research
Investigators
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Principal Investigator: Steven Grinspoon, M.D. Massachusetts General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Steven K. Grinspoon, MD, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02542371    
Other Study ID Numbers: 2014P001832
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: April 2022
Keywords provided by Steven K. Grinspoon, MD, Massachusetts General Hospital:
HIV
Atherosclerosis
Tilmanocept
Additional relevant MeSH terms:
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Arteritis
Inflammation
Pathologic Processes
 Vasculitis
Vascular Diseases
Cardiovascular Diseases