Application of IV 99mTc-tilmanocept for Imaging of Macrophage-specific Inflammation
NCT ID: NCT03523130
Last Updated: 2021-02-26
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
9 participants
OBSERVATIONAL
2018-05-03
2020-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HIV-infected
Imaging
Macrophage-specific inflammation
non-HIV-infected
Imaging
Macrophage-specific inflammation
Interventions
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Imaging
Macrophage-specific inflammation
Eligibility Criteria
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Inclusion Criteria
* current use of antiretroviral therapy (ART), with no changes to regimen within last 3 months
-men and women, ages 18 to 80, without HIV infection
Exclusion Criteria
* 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:
* 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
18 Years
80 Years
ALL
Yes
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Steven K. Grinspoon, MD
Professor of Medicine, Harvard Medical School
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2018P000146
Identifier Type: -
Identifier Source: org_study_id
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