Use of 99mTc Tilmanocept for Imaging Arterial Inflammation

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02542371
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Massachusetts General Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Steven Grinspoon, M.D.
Principal Investigator Affiliation Massachusetts General Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherIndustryOther
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

HIV
Additional Details

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.

Arms & Interventions

Arms

: HIV infected with known subclinical atherosclerosis

: HIV infected without known subclinical atherosclerosis

: Non-HIV infected with known subclinical atherosclerosis

: Non-HIV infected without known subclinical atherosclerosis

Interventions

Other: - Arterial Imaging

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Massachusetts General Hospital, Boston, Massachusetts

Status

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114