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

NCT03523130 | Completed FDA Drug

• 1 other identifier: 2018P000146
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

Macrophage-specific inflammation; Arterial inflammation; Neuroinflammation; SPECT/CT; Tilmanocept

Outcome Measures

Primary Outcomes (1)

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

  within 6 weeks of screening visit

Secondary Outcomes (6)

• Aortic plaque burden and morphology on CT angiography

  within 6 weeks of screening visit

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

  within 6 weeks of screening visit

• Inflammatory markers in relation to cardiovascular imaging outcomes

  within 6 weeks of screening visit

• Imaging assessments of the coronary vasculature

  within 6 weeks of screening visit

• Comparison of imaging assessments between HIV-infected participants and non-HIV-infected participants

  within 6 weeks of screening visit

Study Arms (2)

HIV-infected

Diagnostic Test: Imaging

non-HIV-infected

Diagnostic Test: Imaging

Interventions

Imaging DIAGNOSTIC_TEST

Macrophage-specific inflammation

HIV-infected; non-HIV-infected

Eligibility Criteria

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

Study Population

HIV-infected participants and non-HIV-infected participants

You may qualify if:

• 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

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 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:

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Arteritis; Neuroinflammatory Diseases

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Harvard Medical School

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: May 14, 2018
• Study Start: May 3, 2018
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: February 26, 2021

Record last verified: 2021-02

Locations

US (1)