Clinical Transfer of a Vulnerable Atherosclerotic Plaque Tracer : 99mTc-cAbVCAM1-5 (ATHENA) (ATHENA)

May 22, 2023 updated by: University Hospital, Grenoble

Phase I Study, Prospective, Monocentric, Uncontrolled, Non-randomized, Open, Interventional. First Human Administration of an Inflammation Tracer (99mTc-cAbVCAM1-5) Using the Scintigraphy in Healthy Volunteers and Asymptomatic Patients.

Clinical Transfer of a Tracer of the Vulnerable Atheroma Plate: 99mTc-cAbVCAM1-5. (ATHENA).

This is a phase I/IIa, prospective, monocentric, non-controlled, non-randomized, open-label, interventional study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cardiovascular disease (CVD) is the leading cause of death worldwide with more than 17.6 million deaths. Of these 17.6 millions deaths, 15 millions (85.1%) are attributable to coronary heart disease and cerebrovascular disease, and in both cases the main etiology is atherosclerosis.

In the coronary arteries, while the presence of a stenosing atherosclerotic plate can be detected by the coronary angiography technique that allows visualization of the lumen of the vessels, the same cannot be said of a plate that is vulnerable to eccentric remodeling. Indeed, this plate has little or no effect on the lumen of the artery. As a result, it is undetectable on coronary angiography. These vulnerable coronary atheromatous plaques are characterized by intense inflammatory phenomena leading to the formation of a large lipidic and necrotic heart covered by a thin fibrous capsule. They are prone to rupture, with the immediate consequence of the formation of a thrombus that can cause ischemia and necrosis of the downstream myocardial territory. In practice, 68% of myocardial infarctions are caused by the rupture of vulnerable plaques resulting in stenosis of less than 50% of the vascular lumen. In addition, in two-thirds of cases the infarction is the inaugural clinical event of coronary artery disease.

Currently, there are no validated non-invasive techniques for diagnosing vulnerable atheroma plate. In this context, the Laboratory Radiopharmaceutiques Biocliniques (LRB, UMR_S1039), has selected Vascular Cell Adhesion Molecule 1 (VCAM-1) as a potential target for molecular imaging of vulnerable plate. Indeed, in the arterial tree, its expression is restricted to atheromatous plates presenting an inflammatory phenotype which is considered a major vulnerability criterion. A radiopharmaceutical targeting VCAM-1 (99mTccAbVCAM1-5) has therefore been developed and validated in preclinical studies.

The final objective of this project is to evaluate in clinical practice the potential of this new imaging agent for the non invasive diagnosis of the vulnerable atheroma plates.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Grenoble, France, 38043
        • Grenoble Alpes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Healthy volunteers:

  • Ages 18-55
  • No nuclear imaging or CT scans in the year prior to inclusion
  • A person not exposed to ionizing radiation according to the labour code.

Patients:

  • Ages between 18 and 80
  • Atherosclerosis with asymptomatic carotid atheroma plate.
  • Indication of carotid endarterectomy.

All:

  • Person affiliated with or benefiting from social security
  • Person who has given written informed consent

Non inclusion Criteria:

  • Woman of childbearing potential in the absence of highly effective contraception or man of childbearing potential without mechanical contraception.
  • Medical history that significantly interferes with biodistribution
  • History of disease which may impair the absorption, diffusion and excretion of the radiopharmaceutical: Crohn's disease, celiac disease.
  • Known allergy to one of the constituents of the product.
  • Intoxication with alcohol or drugs on purpose
  • Grade 3 haematological toxicity for the following parameters : Hemoglobin, platelets, leukocytes and neutrophil polynuclear cells.
  • Grade 2 renal toxicity for the following parameters: Urea and creatinine and/or Glomerular filtration rate according to the CPK-EPI formula < 60mL/min/1.73m².
  • Grade 2 liver toxicity for the following parameters : AST, ALT, GGT, PAL and bilirubin.
  • Grade 2 pancreatic toxicity for the following parameter: lipase.
  • Blood or urine pregnancy test (confirmed in blood) inconclusive or positive for women of childbearing potential.
  • Participation in other research involving the type 1 or 2 human being at the same time
  • Person in a period of exclusion from other research involving the human person
  • Living conditions suggesting an inability to follow all the visits provided for in the protocol.
  • Subject who would receive more than 4,500 euros in compensation as a result of participation in other research involving the human person in the 12 months preceding this study.
  • Subject not contactable in case of emergency
  • Protected person (Sections L1121-5 to L1121-8 of the CSP)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 99mTccAbVCAM1-5

Healthy volunteers and asymptomatic patients

  1. Pré-screening of the volunteers by the CIC or the Vascular Surgeon and sending or handing over the newsletter
  2. Visit 0 Selection: Validation of IC / NIC + Consent collection + additional exams
  3. Visit 1 Inclusion: J0 Scintigraphic imaging following injection 99mTc-cAbVCAM1-5 (370 MBq - 550 MBq - 750 MBq depend of the SAE or AE )
  4. Visit 2: Follow-up visit (Day 14 +/- 7 days post injection)
  5. Visit 3: End of the study, follow-up visit (70 days +/- 10 days post injection)
Drug: 99mTccAbVCAM1-5 injection
intravenous injection of 99mTccAbVCAM1-5 with dose increase

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of 99mTc-cAbVCAM1-5 adverse events as assessed by all adverse event according to the NCI Common Terminology Criteria for Adverse Events (CTCAE)_v5.0_2017-11-27.
Time Frame: 70 days after IP injection +/- 10 days
All Adverse events reported according to according to the NCI Common Terminology Criteria for Adverse Events (CTCAE)_v5.0_2017-11-27.
70 days after IP injection +/- 10 days
Evaluation of 99mTc-cAbVCAM1-5 adverse events as assessed by biological parameters.
Time Frame: 24 hours for healthy volonteers, 6 hours for patients.
Total Cholesterol (g/L)
24 hours for healthy volonteers, 6 hours for patients.
Evaluation of 99mTc-cAbVCAM1-5 adverse events as assessed by biological parameters.
Time Frame: 24 hours for healthy volonteers, 6 hours for patients.
Liver enzymes (ASAT - ALAT - GGT)
24 hours for healthy volonteers, 6 hours for patients.
Evaluation of 99mTc-cAbVCAM1-5 adverse events as assessed by biological parameters.
Time Frame: 24 hours for healthy volonteers, 6 hours for patients.
Total bilirubin
24 hours for healthy volonteers, 6 hours for patients.
Evaluation of 99mTc-cAbVCAM1-5 adverse events as assessed by Electrocardiogram.
Time Frame: 24 hours for healthy volonteers, 6 hours for patients and 14 days after IP injection +/- 7 days + 70 days after IP injection for each group
ECG (P Wave, QRS Complex, QT Interval)
24 hours for healthy volonteers, 6 hours for patients and 14 days after IP injection +/- 7 days + 70 days after IP injection for each group
Evaluation of 99mTc-cAbVCAM1-5 adverse events as assessed by vital signs.
Time Frame: 24 hours for healthy volonteers, 6 hours for patients and 14 days after IP injection +/- 7 days + 70 days after IP injection for each group
Blood preasure (mmHg)
24 hours for healthy volonteers, 6 hours for patients and 14 days after IP injection +/- 7 days + 70 days after IP injection for each group
Evaluation of 99mTc-cAbVCAM1-5 adverse events as assessed by vital signs.
Time Frame: 24 hours for healthy volonteers, 6 hours for patients and 14 days after IP injection +/- 7 days + 70 days after IP injection for each group
Heart rate (beats/min)
24 hours for healthy volonteers, 6 hours for patients and 14 days after IP injection +/- 7 days + 70 days after IP injection for each group

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of biodistribution in all subjects included in the study (healthy volunteers + patients)
Time Frame: 24 hours for healthy volonteers, 6 hours for patients.
Radioactive activity (MBq) measured in urine, blood and stool + full body images
24 hours for healthy volonteers, 6 hours for patients.
Dosimetry evaluation of 99mTc-cAbVCAM1-5 in healthy volunteers and patients.
Time Frame: 24 hours for healthy volonteers, 6 hours for patients.
Dosimetry mesured in healthy subjects and patients in the different organs
24 hours for healthy volonteers, 6 hours for patients.
Evaluation of the feasibility of the technique using 99mTccAbVCAM1-5 as a tracer for the vulnerable atheroma plate.
Time Frame: 3 hours after injection
Verification of the concordance between the expression of VCAM-1 in imaging and on operative part of carotid endarterectomy in patients. Comparison between the intensity of the 99mTc-cAbVCAM1-5 signal observed at the level of the carotids and the level of expression of VCAM-1 determined on an operative endarterectomy part of the carotid concerned, by immunohistochemistry and / or ELISA assay.
3 hours after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Grenoble

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicolas DE LEIRIS, Grenoble Alpes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 38RC19.051

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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