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

NCT04483167 | Unknown Phase 1 DMC

• 1 other identifier: 38RC19.051
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Diseases; Atherosclerosis

Keywords

99mTc-cAbVCAM1-5; intravenous injection

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  Total bilirubin

  24 hours for healthy volonteers, 6 hours for patients.

• Evaluation of 99mTc-cAbVCAM1-5 adverse events as assessed by Electrocardiogram.

  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.

  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.

  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 Outcomes (3)

• Assessment of biodistribution in all subjects included in the study (healthy volunteers + patients)

  24 hours for healthy volonteers, 6 hours for patients.

• Dosimetry evaluation of 99mTc-cAbVCAM1-5 in healthy volunteers and patients.

  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.

  3 hours after injection

Study Arms (1)

99mTccAbVCAM1-5

EXPERIMENTAL

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

Interventions

99mTccAbVCAM1-5 injection DRUG

intravenous injection of 99mTccAbVCAM1-5 with dose increase

99mTccAbVCAM1-5

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers:
• Ages 18-55
• 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
• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Grenoble Alpes University Hospital

Grenoble, 38043, France

Location

Related Publications (2)

• GBD 2016 Causes of Death Collaborators. Global, regional, and national age-sex specific mortality for 264 causes of death, 1980-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1151-1210. doi: 10.1016/S0140-6736(17)32152-9.

  PMID: 28919116 BACKGROUND

• Little WC, Constantinescu M, Applegate RJ, Kutcher MA, Burrows MT, Kahl FR, Santamore WP. Can coronary angiography predict the site of a subsequent myocardial infarction in patients with mild-to-moderate coronary artery disease? Circulation. 1988 Nov;78(5 Pt 1):1157-66. doi: 10.1161/01.cir.78.5.1157.

  PMID: 3180375 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Nicolas DE LEIRIS

  Grenoble Alpes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 7 healthy volunteers (1+3+3) and 6 asymptomatic patients

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: July 23, 2020
• Study Start: September 15, 2020
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)