HIVNCT03523130
Application of IV 99mTc-tilmanocept for Imaging of Macrophage-specific Inflammation
An observational study of HIV, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Imaging
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2018to 30 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV-infected participants and non-HIV-infected participants
Who may be able to join
- 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
- -men and women, ages 18 to 80, without HIV infection
Who cannot join
- 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
Show all 27Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- HIV
- Being tested
- Imaging
- Keywords
- Macrophage-specific inflammation, Arterial inflammation, Neuroinflammation, SPECT/CT, Tilmanocept
- Medical subject headings
- Arteritis, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImagingDiagnostic test
Macrophage-specific inflammation
| Study group | Role | What they receive |
|---|---|---|
| HIV-infected | Not described Receives: Diagnostic Test: Imaging | |
| non-HIV-infected | Not described Receives: Diagnostic Test: Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic uptake of intravenously administered 99mTc tilmanocept on SPECT/CT
Measured: within 6 weeks of screening visit
Secondary outcomes (6)
Aortic plaque burden and morphology on CT angiography
Aortic plaque burden and morphology will be assessed through measurement of total, calcified, and non-calcified aortic plaque volume (mm3).
Measured: within 6 weeks of screening visit
Traditional markers of cardiovascular disease (CVD) risk in relation to cardiovascular imaging outcomes
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.
Measured: within 6 weeks of screening visit
Inflammatory markers in relation to cardiovascular imaging outcomes
The following inflammatory markers will be evaluated: soluble CD163 (ng/ml) , soluble CD 14 (ng/ml) , and Lp-PLA2 (ng/ml).
Measured: within 6 weeks of screening visit
Imaging assessments of the coronary vasculature
Cardiac CT angiography will be used to assess the coronary vasculature. Total, calcified, and non-calcified coronary plaque volume (mm3) will be measured.
Measured: within 6 weeks of screening visit
Comparison of imaging assessments between HIV-infected participants and non-HIV-infected participants
We will compare the standardized uptake values on SPECT/CT of HIV-infected participants and non-HIV-infected participants.
Measured: within 6 weeks of screening visit
Uptake of intravenously administered 99mTc tilmanocept on SPECT/CT in regions other than the aorta
Uptake of tilmanocept on SPECT/CT will determined by calculating a standardized uptake value.
Measured: within 6 weeks of screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start3 May 2018
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven K. Grinspoon, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523130
- Sponsor's protocol ID
- 2018P000146
- Status last verified
- Feb 2021
- First submitted
- 17 Apr 2018
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of IV 99mTc-tilmanocept for Imaging of Macrophage-specific Inflammation
- ClinicalTrials.gov ID
- NCT03523130
- Acronym / sponsor ID
- 2018P000146
- Conditions
- HIV
- Keywords
- Macrophage-specific inflammation, Arterial inflammation, Neuroinflammation, SPECT/CT, Tilmanocept
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 3 May 2018 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-infected | – | Diagnostic Test: Imaging |
| non-HIV-infected | – | Diagnostic Test: Imaging |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected participants and non-HIV-infected participants
Key inclusion criteria (3 listed)
- 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
- -men and women, ages 18 to 80, without HIV infection
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImagingMacrophage-specific inflammation | Diagnostic test | HIV-infected, non-HIV-infected |
Primary outcome
Aortic uptake of intravenously administered 99mTc tilmanocept on SPECT/CT
Time frame: within 6 weeks of screening visit
6 secondary outcomes
Aortic plaque burden and morphology on CT angiography
Time frame: within 6 weeks of screening visit
Traditional markers of cardiovascular disease (CVD) risk in relation to cardiovascular imaging outcomes
Time frame: within 6 weeks of screening visit
Inflammatory markers in relation to cardiovascular imaging outcomes
Time frame: within 6 weeks of screening visit
Imaging assessments of the coronary vasculature
Time frame: within 6 weeks of screening visit
Comparison of imaging assessments between HIV-infected participants and non-HIV-infected participants
Time frame: within 6 weeks of screening visit
Uptake of intravenously administered 99mTc tilmanocept on SPECT/CT in regions other than the aorta
Time frame: within 6 weeks of screening visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aortic uptake of intravenously administered 99mTc tilmanocept on SPECT/CT (time frame: within 6 weeks of screening visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.