Coronary ArteriosclerosisPhase 3iPROGRESSNCT04043377
68Ga-DOTATATE PET-CTA Imaging for the Early Detection of Progressing Coronary Atherosclerosis
A Phase 3 study testing injection of 68Ga-DOTATATE in people with Coronary Arteriosclerosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
68Ga-DOTATATE is a PET radiotracer with high affinity and selectivity for somatostatin receptor 2 (SSTR 2) and is approved clinically for the evaluation of patients with neuroendocrine tumors. The SSTR2 receptor is also highly expressed at the surface of human macrophages and lymphocytes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arteriosclerosis
- What is being tested?
- injection of 68Ga-DOTATATE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2019to 13 Sep 2021
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a coronary artery calcium score (CACS) measured with a low-dose CT between 100 and 1000 and absence of significant ischemia (≥ 12 % of the myocardium) on myocardial perfusion scintigraphy.
- Age ≥ 18 years
- Affiliation to a social security regime
- Signed informed consent.
Who cannot join
- Previous acute coronary syndrome or coronary revascularisation
- LVEF < 40 %
- Previous severe adverse reaction to iodinated contrast agent
- Irregular heart rhythm (chronic atrial fibrillation, numerous extrasystoles)
- Severe asthma
- Chronic kidney disease (eGFR < 45 ml/min/1.73 m2)
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- Waldenstrom disease
- Multiple myeloma
- Autoimmune / inflammatory disease requiring immunosuppressive treatment.
- Active cancer.
- Confirmed or suspected pregnancy
- Breast feeding
- Impossibility to stay immobile and maintain the supine position during 30 minutes.
- Patient deprived of liberty or under legal protection measure
- Participation to an interventional trial involving the use of radiation during the two years of the study.
- Participation to an interventional trial with the use of new drugs between the inclusion and one month after injecting 68Ga-DOTATATE.
Trial locations and contacts
1 site in 1 country.
About this study
68Ga-DOTATATE is a PET radiotracer with high affinity and selectivity for somatostatin receptor 2 (SSTR 2) and is approved clinically for the evaluation of patients with neuroendocrine tumors. The SSTR2 receptor is also highly expressed at the surface of human macrophages and lymphocytes. In comparison to FDG, 68Ga-DOTATATE presents the advantage of fast clearance from tissues, which are not expressing somatostatin receptors, in particular muscular and myocardial tissues, and the level of blood glucose does not influence its uptake.
Accumulation of 68Ga-DOTATATE has already been detected in coronary and carotid plaques and is associated with the number of activated macrophages present in plaques obtained after carotid endarterectomy. In a recent study, Tarkin et al. confirmed the preferential uptake of 68Ga-DOTATATE by macrophages in atherosclerotic plaques. In addition, the intensity of 68Ga-DOTATATE was higher in culprit lesions in the carotid and coronary arteries than in stable lesions. The evaluation of 68Ga-DOTATATE uptake in coronary arteries was also strongly facilitated in comparison to FDG thanks to the absence of spillover signal from the myocardium.
AAA has developed a new kit that has markedly simplified the synthesis of 68Ga-DOTATATE and has obtained in the US marketing authorization for the kit (Netspot; kit for the preparation of Gallium-68-DOTATATE injection for intravenous use) on June 1st 2016 (NDA 208547) for evaluation of patients with neuro-endocrine tumors. The Netspot kit will be used in this study for the detection of progressing coronary atherosclerosis.
Read the detailed description
Design of the trial :
iPROGRESS is a prospective interventional study. The primary objective of this study will be to test the association between the intensity of 68Ga-DOTATATE uptake in coronary plaques quantified with PET at M0 and the absolute progression rate of coronary artery calcium scoring (CACS) measured between the CT acquired at M0 and after 2 years.
Patients will be screened until 1 month before the inclusion (M0) visit. Thereafter, 3 visits specifics to the study will be performed.
M0 (baseline): Injection of 68Ga-DOTATATE followed by PET-scan and a CCTA-scan M12 et M24(follow-up): Consultation and low-dose cardiac CT for coronary calcium scoring performed
- Conditions
- Coronary Arteriosclerosis
- Being tested
- injection of 68Ga-DOTATATE
- Keywords
- Coronary atherosclerosis, 68Ga-DOTATATE, PET-CTA imaging, No significant myocardial ischemia
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of 68Ga-DOTATATEDrug
PET after injection of 68Ga-DOTATATE 2 MBq/kg (Max. 200 MBq); intra-venous; single injection, at M0 followed by a coronary CTA to localize the signal in coronary arteries Consultation and low-dose cardiac CT for coronary calcium scoring performed at M12 and M24 after inclusion.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | Not described Receives: Drug: injection of 68Ga-DOTATATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute increase in calcium artery calcium scoring (CACS) per year.
The volume of calcium along coronary arteries will be measured on low-dose gated CT acquisitions using a dedicated software. The increase in CACS will be measured as the difference between the CACS measured at baseline and 2 years later and a yearly increase rate of CACS will be calculated.
Measured: 2 years
Secondary outcomes (8)
Combined end point including cardiovascular death, acute coronary syndrome and ischemia-driven coronary revascularization.
Two years after the inclusion, the patient will be interviewed for the occurrence of cardiovascular events. In case of a suspicion of cardiovascular event, the report of the hospital will be collected or the physician in charge of the patient will be contacted.
Measured: 2 years
Characterization of coronary plaques 1
Coronary CTA will be analysed using a dedicated software. Each coronary plaque detected on the CCTA will be characterized as:
- non-calcified
- mixed
- calcified High-risk plaques will be defined on CCTA as non-calcified plaque with hypodense region and positive remodelling.
Measured: 2 years
Characterization of coronary plaques 2
Coronary CTA will be analysed using a dedicated software. Each coronary plaque detected on the CCTA will be characterized as:
- presence of hypodense region
- absence of hypodense region (< 30 HU), High-risk plaques will be defined on CCTA as non-calcified plaque with hypodense region and positive remodelling.
Measured: 2 years
Characterization of coronary plaques 3
Coronary CTA will be analysed using a dedicated software. Each coronary plaque detected on the CCTA will be characterized by: maximal plaque surface.
High-risk plaques will be defined on CCTA as non-calcified plaque with hypodense region and positive remodelling.
Measured: 2 years
Characterization of coronary plaques 4
Coronary CTA will be analysed using a dedicated software. Each coronary plaque detected on the CCTA will be characterized by: plaque remodelling ratio.
High-risk plaques will be defined on CCTA as non-calcified plaque with hypodense region and positive remodelling.
Measured: 2 years
Characterization of coronary plaques 5
Coronary CTA will be analysed using a dedicated software. Each coronary plaque detected on the CCTA will be characterized by: degree of luminal stenosis (%).
High-risk plaques will be defined on CCTA as non-calcified plaque with hypodense region and positive remodelling.
Measured: 2 years
MDS TBR of coronary arteries and global TBR of the thoracic aorta.
The most-diseased segment (MDS) will be defined as the max. TBR value with the highest signal along coronary arteries for each patient. Global TBR of the thoracic aorta will be calculated as the average of max. TBR measured on 2D ROI placed on the thoracic aorta.
Measured: 2 years
68Ga-DOTATATE uptake in the parodontal bone.
The intensity of 68Ga-DOTATATE uptake in periodontal bone will be measured on the PET acquired at M0 as average of four TBR max. values measured in each quadrant of the mouth.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start21 Nov 2019
- Primary completion13 Sep 2021
- Study completion13 Sep 2021
Why it stopped: Financial issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary ArteriosclerosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabien HYAFIL, Doctor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043377
- Sponsor's protocol ID
- P 171103
- Other IDs
- 2017-004793-34, 2017
- Acronym
- iPROGRESS
- Status last verified
- Jun 2022
- First submitted
- 23 Jul 2019
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-DOTATATE PET-CTA Imaging for the Early Detection of Progressing Coronary Atherosclerosis
- ClinicalTrials.gov ID
- NCT04043377
- Acronym / sponsor ID
- iPROGRESS / P 171103
- Conditions
- Coronary Arteriosclerosis
- Keywords
- Coronary atherosclerosis, 68Ga-DOTATATE, PET-CTA imaging, No significant myocardial ischemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Financial issues
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 13 Sep 2021 (actual)
- Study completion
- 13 Sep 2021 (actual)
- First posted
- 2 Aug 2019 (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.
68Ga-DOTATATE is a PET radiotracer with high affinity and selectivity for somatostatin receptor 2 (SSTR 2) and is approved clinically for the evaluation of patients with neuroendocrine tumors. The SSTR2 receptor is also highly expressed at the surface of human macrophages and lymphocytes. In comparison to FDG, 68Ga-DOTATATE presents the advantage of fast clearance from tissues, which are not expressing somatostatin receptors, in particular muscular and myocardial tissues, and the level of blood glucose does not influence its uptake.
Accumulation of 68Ga-DOTATATE has already been detected in coronary and carotid plaques and is associated with the number of activated macrophages present in plaques obtained after carotid endarterectomy. In a recent study, Tarkin et al. confirmed the preferential uptake of 68Ga-DOTATATE by macrophages in atherosclerotic plaques. In addition, the intensity of 68Ga-DOTATATE was higher in culprit lesions in the carotid and coronary arteries than in stable lesions. The evaluation of 68Ga-DOTATATE uptake in coronary arteries was also strongly facilitated in comparison to FDG thanks to the absence of spillover signal from the myocardium.
AAA has developed a new kit that has markedly simplified the synthesis of 68Ga-DOTATATE and has obtained in the US marketing authorization for the kit (Netspot; kit for the preparation of Gallium-68-DOTATATE injection for intravenous use) on June 1st 2016 (NDA 208547) for evaluation of patients with neuro-endocrine tumors. The Netspot kit will be used in this study for the detection of progressing coronary atherosclerosis.
Detailed description
Design of the trial :
iPROGRESS is a prospective interventional study. The primary objective of this study will be to test the association between the intensity of 68Ga-DOTATATE uptake in coronary plaques quantified with PET at M0 and the absolute progression rate of coronary artery calcium scoring (CACS) measured between the CT acquired at M0 and after 2 years.
Patients will be screened until 1 month before the inclusion (M0) visit. Thereafter, 3 visits specifics to the study will be performed.
M0 (baseline): Injection of 68Ga-DOTATATE followed by PET-scan and a CCTA-scan M12 et M24(follow-up): Consultation and low-dose cardiac CT for coronary calcium scoring performed
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Drug: injection of 68Ga-DOTATATE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a coronary artery calcium score (CACS) measured with a low-dose CT between 100 and 1000 and absence of significant ischemia (≥ 12 % of the myocardium) on myocardial perfusion scintigraphy.
- Age ≥ 18 years
- Affiliation to a social security regime
- Signed informed consent.
Key exclusion criteria (16 listed)
- Previous acute coronary syndrome or coronary revascularisation
- LVEF < 40 %
- Previous severe adverse reaction to iodinated contrast agent
- Irregular heart rhythm (chronic atrial fibrillation, numerous extrasystoles)
- Severe asthma
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 |
|---|---|---|
| injection of 68Ga-DOTATATEPET after injection of 68Ga-DOTATATE 2 MBq/kg (Max. 200 MBq); intra-venous; single injection, at M0 followed by a coronary CTA to localize the signal in coronary arteries Consultation and low-dose cardiac CT for coronary calcium scoring performed at M12 and M24 after inclusion. | Drug | All patients |
Primary outcome
Absolute increase in calcium artery calcium scoring (CACS) per year.
Time frame: 2 years
The volume of calcium along coronary arteries will be measured on low-dose gated CT acquisitions using a dedicated software. The increase in CACS will be measured as the difference between the CACS measured at baseline and 2 years later and a yearly increase rate of CACS will be calculated.
8 secondary outcomes
Combined end point including cardiovascular death, acute coronary syndrome and ischemia-driven coronary revascularization.
Time frame: 2 years
Characterization of coronary plaques 1
Time frame: 2 years
Characterization of coronary plaques 2
Time frame: 2 years
Characterization of coronary plaques 3
Time frame: 2 years
Characterization of coronary plaques 4
Time frame: 2 years
Characterization of coronary plaques 5
Time frame: 2 years
MDS TBR of coronary arteries and global TBR of the thoracic aorta.
Time frame: 2 years
68Ga-DOTATATE uptake in the parodontal bone.
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Financial issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
Fabien HYAFIL, Doctor principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing injection of 68Ga-DOTATATE in people with Coronary Arteriosclerosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 16 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 30 Jun 2022. 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 France. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: Financial 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?
Absolute increase in calcium artery calcium scoring (CACS) per year. (time frame: 2 years). 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 30 Jun 2022.