InflammationPhase 1/2NCT01608516
Multimodal Imaging Assessment of the Inflammatory Atheromatous Plaque
A Phase 1/2 study testing 68Ga-NODAGA-RGD PET/CT in people with Inflammation and Atheromatous Plaques, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
The present study aims at assessing the ability of 68Ga-NODAGA-RGD PET/CT for the detection of inflammatory atheromatous plaques in the carotid arteries, compared to 18F-FDG PET/CT, MRI and US and to determine the contribution of each imaging technique. Current gold standard for inflammation is histopathology. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Inflammation, Atheromatous Plaques, Carotid Artery Diseases
- What is being tested?
- 68Ga-NODAGA-RGD PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2012to Jul 2026
- Phase
- Phase 1/2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age <= 85 years
- Karnofsky >= 80%
- patient with indication ofr carotid endarterectomy
- signed consent form
Who cannot join
- indication for surgery other than endarterectomy <14 days
- contraindication to surgery
- contraindication to MRI
- contraindication to gadolinium injection (stage 4/5 kidney insufficiency, GFR<30ml/min/1.73m2)
- pregnancy, breastfeeding
- lack of discernment
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
About this study
Official title: Multimodal Assessment of the Inflammatory Atheromatous Plaque : Comparison Between 68Ga-NODAGA-RGD PET/CT, 18F-FDG PET/CT, MRI AND US
The present study aims at assessing the ability of 68Ga-NODAGA-RGD PET/CT for the detection of inflammatory atheromatous plaques in the carotid arteries, compared to 18F-FDG PET/CT, MRI and US and to determine the contribution of each imaging technique. Current gold standard for inflammation is histopathology.
Hypothesis : 68Ga-NODAGA-RGD might give a better initial evaluation of patients with atheromatous plaques in the carotid artery eligible for endarterectomy.
Read the detailed description
Patients with indication for endarterectomy will be presented the present protocol. If inclusion criteria are fulfilled, patients will have a 18F-FDG PET/CT + carotid US performed 6 to 2 days before endarterectomy and 68Ga-NODAGA-RGD PET/CT + MRI performed the day before endarterectomy. Histopathological sample will be analyzed to measure plaque inflammation.
All imaging results and histopathology results will be pooled and compared.
- Conditions
- Inflammation, Atheromatous Plaques, Carotid Artery Diseases
- Being tested
- 68Ga-NODAGA-RGD PET/CT
- Keywords
- PET/CT, 68Ga-NODAGA-RGD, 18F-FDG, MRI, US ultrasound, inflammatory atheromatous plaque, endarterectomy
- Medical subject headings
- Inflammation, Plaque, Atherosclerotic, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NODAGA-RGD PET/CTDrug
200 MBq 68 Ga-NODAGA-RGD will be administered i.v. and images centred on the carotid area acquired
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-NODAGA-RGD radiotracer | Experimental | All patients will undergo a 68Ga-NODAGA-RGD PET/CT, a 18F-FDG PET/CT, a MRI and a US. Receives: Drug: 68Ga-NODAGA-RGD PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of each method of imaging for the detection of inflammatory atheromatous plaques
The potential of each of the methods of imaging for the detection of inflammatory atheromatous plaques will be compared. For that purpose, the capacity of every criterion of primary assessment to determine the presence of an unstable plaque will be studied compared with the histopathological sample.
Measured: Within1 month of endarterectomy
Secondary outcomes (2)
Comparison of AUC of the imaging methods
A comparison of the AUC will be realized to determine the superiority of a method compared with the other one, by a non parametric test comparing AUC , ROC curves respectively.
Measured: Within1 month of endarterectomy
Analysis of histopathological sample of endarterectomy
The histopathological analysis will be the degree of local inflammation estimated by the macrophagic infiltration as well as the degree of neovascularization.
Measured: Within1 month of endarterectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2026
- Study completionJul 2026
Why it stopped: studdy stopped because of patient recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Heart Foundation
- Responsible party
- Principal investigator, John O. Prior, University of Lausanne Hospitals
- Investigators
- John O. Prior, PhD, MD, Principal investigator, Lausanne University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608516
- Sponsor's protocol ID
- 80/10
- Status last verified
- Jul 2026
- First submitted
- 16 Apr 2012
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gnesin S, Mitsakis P, Cicone F, Deshayes E, Dunet V, Gallino AF, Kosinski M, Baechler S, Buchegger F, Viertl D, Prior JO. First in-human radiation dosimetry of 68Ga-NODAGA-RGDyK. EJNMMI Res. 2017 Dec;7(1):43. doi: 10.1186/s13550-017-0288-x. Epub 2017 May 18.
PubMed 28523582
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Assessment of the Inflammatory Atheromatous Plaque : Comparison Between 68Ga-NODAGA-RGD PET/CT, 18F-FDG PET/CT, MRI AND US
- ClinicalTrials.gov ID
- NCT01608516
- Acronym / sponsor ID
- 80/10
- Conditions
- Inflammation, Atheromatous Plaques, Carotid Artery Diseases
- Keywords
- PET/CT, 68Ga-NODAGA-RGD, 18F-FDG, MRI, US ultrasound, inflammatory atheromatous plaque, endarterectomy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: studdy stopped because of patient recruitment issues
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Collaborators
- Swiss Heart Foundation
- Study start
- Apr 2012 (actual)
- Primary completion
- Jul 2026 (actual)
- Study completion
- Jul 2026 (actual)
- First posted
- 31 May 2012 (estimated)
- 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 present study aims at assessing the ability of 68Ga-NODAGA-RGD PET/CT for the detection of inflammatory atheromatous plaques in the carotid arteries, compared to 18F-FDG PET/CT, MRI and US and to determine the contribution of each imaging technique. Current gold standard for inflammation is histopathology.
Hypothesis : 68Ga-NODAGA-RGD might give a better initial evaluation of patients with atheromatous plaques in the carotid artery eligible for endarterectomy.
Detailed description
Patients with indication for endarterectomy will be presented the present protocol. If inclusion criteria are fulfilled, patients will have a 18F-FDG PET/CT + carotid US performed 6 to 2 days before endarterectomy and 68Ga-NODAGA-RGD PET/CT + MRI performed the day before endarterectomy. Histopathological sample will be analyzed to measure plaque inflammation.
All imaging results and histopathology results will be pooled and compared.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-NODAGA-RGD radiotracer | Experimental | Drug: 68Ga-NODAGA-RGD PET/CTAll patients will undergo a 68Ga-NODAGA-RGD PET/CT, a 18F-FDG PET/CT, a MRI and a US. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age <= 85 years
- Karnofsky >= 80%
- patient with indication ofr carotid endarterectomy
- signed consent form
Key exclusion criteria (6 listed)
- indication for surgery other than endarterectomy <14 days
- contraindication to surgery
- contraindication to MRI
- contraindication to gadolinium injection (stage 4/5 kidney insufficiency, GFR<30ml/min/1.73m2)
- pregnancy, breastfeeding
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 |
|---|---|---|
| 68Ga-NODAGA-RGD PET/CT200 MBq 68 Ga-NODAGA-RGD will be administered i.v. and images centred on the carotid area acquired | Drug | 68Ga-NODAGA-RGD radiotracer |
Primary outcome
Comparison of each method of imaging for the detection of inflammatory atheromatous plaques
Time frame: Within1 month of endarterectomy
The potential of each of the methods of imaging for the detection of inflammatory atheromatous plaques will be compared. For that purpose, the capacity of every criterion of primary assessment to determine the presence of an unstable plaque will be studied compared with the histopathological sample.
2 secondary outcomes
Comparison of AUC of the imaging methods
Time frame: Within1 month of endarterectomy
Analysis of histopathological sample of endarterectomy
Time frame: Within1 month of endarterectomy
Results and safety
The study was stopped early (reason given: studdy stopped because of patient recruitment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Derived from this study: PubMed 28523582Gnesin S, Mitsakis P, Cicone F, Deshayes E, Dunet V, Gallino AF, Kosinski M, Baechler S, Buchegger F, Viertl D, Prior JO. First in-human radiation dosimetry of 68Ga-NODAGA-RGDyK. EJNMMI Res. 2017 Dec;7(1):43. doi: 10.1186/s13550-017-0288-x. Epub 2017 May 18.
- Individual participant dataSharing planned: No
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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.
John O. Prior, PhD, MD principal investigator
Lausanne University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 68Ga-NODAGA-RGD PET/CT in people with Inflammation and Atheromatous Plaques, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 16 Jul 2026. 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 Switzerland. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: studdy stopped because of patient recruitment issues). Results are not available in the source record.
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?
Comparison of each method of imaging for the detection of inflammatory atheromatous plaques (time frame: Within1 month of endarterectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01608516, which also lists 1 linked publication.
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 16 Jul 2026.