Study Stopped
Problem of supply of the experimental product (radio tracer).
99m Tc-ANNexin-V-128 Scintigraphy for the Identification of Complicated Carotid Atherosclerotic Plaques
ANNICA
2 other identifiers
interventional
N/A
0 countries
N/A
Brief Summary
The aim of this trial will be to test and validate the value of scintigraphy with injection of 99mTc-Annexin-V-128 for the detection of complicated carotid plaques
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2018
CompletedFirst Posted
Study publicly available on registry
August 15, 2018
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedOctober 20, 2021
October 1, 2021
1.6 years
August 10, 2018
October 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
assess the concordance between the detection of 99mTc-Annexin-V-128 uptake on scintigraphy in carotid plaques with SPECT and the presence of complicated plaques on histology obtained after carotid endarterectomy
Concordance will be assessed by Cohen's kappa coefficient between: \- detection of 99mTc-Annexin-V-128 uptake on scintigraphy in the carotid bulb localized using the CTA 90 minutes after injection of the radiotracer ipsi-lateral to the carotid endarterectomy. And \- presence of complicated atherosclerotic plaques after carotid endarterectomy validated by an Endpoint Adjudication Committee composed of vascular surgeons and pathologists that will review macroscopical aspects of carotid specimen and histology of all explanted carotid plaques.
no later than one month after baseline.
Secondary Outcomes (5)
to evaluate the correlation between the intensity of 99mTc-Annexin-V-128 uptake detected on SPECT and the expression of Annexin-V on immuno-histology of carotid plaques
no later than one month after baseline.
to evaluate the relationship between the intensity of 99mTc-Annexin-V-128 uptake detected on SPECT and the morphological aspects of plaques on histology
no later than one month after baseline.
to assess diagnostic performance of 99mTc-Annexin-V-128 scintigraphy for the detection of complicated carotid plaques detected on histology in patients referred for carotid endarterectomy.
no later than one month after baseline.
to compare the intensity of the 99mTc-Annexin-V-128 uptake in ipsilateral (symptomatic) and contralateral (asymptomatic) carotid artery.
no later than one month after baseline.
to test the intra- and inter-operator reproducibility of the analysis of 99mTc-Annexin-V-128 uptake in carotid bulb
no later than one month after baseline.
Study Arms (1)
99mTc-Annexin-V-128 uptake on scintigraphy
EXPERIMENTALInterventions
An intravenous catheter will be placed in the forearm and a dose of 370 Mega-Becquerels of 99mTc-Annexin-V-128 (1-2 ml) over 10 seconds will be injected through the catheter. The patient will wait for 90 minutes in semi-supine position for the clearance of the radiotracer from blood. At 90 minutes p.i., the patient will be placed in a supine position on the bed of a SPECT-CT gamma-camera. A SPECT acquisition including the heart and the brain will be performed over 20 minutes. At the end of the SPECT acquisition, the bed will move to the CT of the imaging system. A CT angiography will be acquired during the intravenous injection of 30-40 ml of iodinated CT contrast agent from the heart to the brain to localize the signal on the SPECT images. The iodinated contrast agent that is currently available at Bichat Hospital for CTA is Iomeron 400 provided by Bracco Imaging. The total duration of the imaging study will be 2 hours.
Eligibility Criteria
You may qualify if:
- years ≤ Age ≤ 90 years
- Patients with clinical indications to carotid endarterectomy
- Signed the consent form.
- Affiliation of a social security regime
You may not qualify if:
- Non-menopausal women
- Chronic kidney disease (eGFR \< 45 ml/min/1.73 m2)
- Waldenstrom disease
- Multiple myeloma
- Previous severe adverse reaction to iodinated contrast agent
- Impossibility to stay immobile and maintain the supine position during 20 minutes.
- Altered consciousness or inability to understand the consent form.
- Urinary incontinence without implantation of urinary catheter (risk of urinary contamination).
- Non-atherosclerotic carotid stenosis (history of cervical radiation).
- Patient deprived of liberty or under legal protection measure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre AMARENCO, MD PhD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2018
First Posted
August 15, 2018
Study Start
September 1, 2018
Primary Completion
April 1, 2020
Study Completion
April 1, 2020
Last Updated
October 20, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share