Cardiovascular DiseaseCAMONANCT01724749
Cardiovascular Molecular Calcification Assessed by 18F-NaF PET CT
An observational study of Cardiovascular Disease and Atherosclerosis, run by Odense University Hospital at 2 sites in Denmark.
Trial summary
The purpose of the CAMONA study is to demonstrate the feasibility of cardiovascular molecular calcification (CMC) assessment by means of 18F-sodium-fluoride (18F-NaF) positron emission tomography (PET) computed tomography (CT) in a prospective cohort of healthy control subjects and subjects with cardiovascular disease. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Atherosclerosis, Angina Pectoris
- How many people
- 144 participants
- Where
- 2 sitesDenmark
- Study dates
- Nov 2012to Dec 2016
- Phase
- Observational
- 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy control subjects will be recruited from a random sample of Danish citizens. To secure timely inclusion of healthy controls, blood donors will be approached for inclusion as well. Subjects with symptoms suggesting angina pectoris will be recruited from the Department of Cardiology, Odense University Hospital. Each patient referred for symptoms suggesting angina pectoris and eligibility for a coronary artery calcium scoring (CACS) will be eligible for inclusion in the investigators study.
Who may be able to join
- Age: 21 - 80 years
- Healthy controls: No prior history or symptoms of cardiovascular disease
- Cardiology subjects: Eligibility for CACS due to symptoms suggesting angina pectoris.
- Cardiology subjects: HeartSCORE > 0%.
Who cannot join
- Pregnancy
- Extensive physical activity or extensive partying passed 24 hours
- History of malignant neoplasms with past 5 years
- Known immunodeficiencies
- History of deep vein thrombosis or acute pulmonary embolism within the previous three months
- History of alcohol abuses, illicit drug use, or drug abuse, or significant mental illness
Show all 10Show fewer
- Initiation of statin-therapy within 3 months prior to consideration of study enrolment
- History of autoimmune disease, such as systemic lupus erythematosus, inflammatory bowel disease, sarcoidosis, rheumatoid arthritis, or psoriasis.
- Participation in any clinical trial of an investigational drug, device, or medical procedure within 30 days prior to baseline of the study
- Enrolment or planned enrolment in another clinical trial during the study period
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Department of Cardiology, Odense University Hospital
Odense, Region Syddanmark, 5000
Axel Diederichsen, MD, Axel.Diederichsen@ouh.regionsyddanmark.dk
- Recruiting
Department of Nuclear Medicine, Odense University Hospital
Odense, Region Syddanmark, 5000
Poul F Høilund-Carlsen, MD, DMSc, pfhc@ouh.regionsyddanmark.dk
Björn A Blomberg, MD, MSc
About this study
Official title: Cardiovascular Molecular Calcification Assessed by 18F-NaF PET CT: The CAMONA Study
The purpose of the CAMONA study is to demonstrate the feasibility of cardiovascular molecular calcification (CMC) assessment by means of 18F-sodium-fluoride (18F-NaF) positron emission tomography (PET) computed tomography (CT) in a prospective cohort of healthy control subjects and subjects with cardiovascular disease.
Read the detailed description
Atherosclerosis associated cardiovascular disease (CVD) remains a significant cause of morbidity and mortality. Asymptomatic individuals with a moderate to high-risk of developing acute atherosclerotic cardiovascular events will benefit most from intensive evidence-based medical interventions.
The traditional approach to identify patients with moderate to high-risk of CVD involves quantifying the presence of CVD risk factors. Based on gender, age, smoking, systolic blood pressure and cholesterol levels, risk stratification algorithms such as the Framingham Risk Score (FRS) and the European SCORE system can predict the 10-year risk of cardiovascular death.
However, these algorithms are associated with several limitations, including misclassification of women and individuals with high levels of a single risk factor. The risk is underestimated in these individuals. Therefore, these individuals are not eligible for treatment by current criteria of CVD prevention guidelines. Several studies indicate that the traditional risk score models leave room for improvement, as they work reasonably well for populations, but remain suboptimal for individual subjects.
New risk parameters are discovered on a regular basis. One of these parameters is cardiovascular molecular calcification (CMC). This entity can be detected and quantified by 18F-NaF PET CT. It has been hypothesized that CMC can be detected years, maybe even decades, before coronary artery calcium scoring (CACS) can be detected by conventional imaging modalities like multislice CT. Theoretically, this tool can detect patients at a very early stage of the disease. Providing evidence-based treatment to these individuals can, theoretically, improve the prevention of CVD. Before this hypothesises can be tested, the feasibility of 18F-NaF PET CT has to be demonstrated in both healthy controls as well as in subjects with cardiovascular disease.
- Conditions
- Cardiovascular Disease, Atherosclerosis, Angina Pectoris
- Keywords
- Atherosclerosis, Sodium-Fluoride, 18F-Sodium Fluoride, 18F-NaF, fluorodeoxyglucose, 18F-FDG, FDG, Positron emission tomography, PET
- Medical subject headings
- Cardiovascular Diseases, Atherosclerosis, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy control subjects | 1. Age: 21 - 80 years 2. No prior history or symptoms of cardiovascular disease The investigators aim to include equal numbers of females and males. Furthermore, the investigators aim to include patients in six different age strata: 21-30, 31-40, 41-50, 51-60, 61-70, 71-80. | |
| Subjects with cardiovascular disease | 1. Age: 21 - 80 years 2. HeartSCORE > 0% 3. Symptoms of angina pectoris The investigators aim to include equal numbers of females and males. Furthermore, the investigators aim to include patients in six different age strata: 21-30, 31-40, 41-50, 51-60, 61-70, 71-80. Also, the investigators aim to include patients in 3 strata of HeartSCORE risk: low risk (1-4%), mild risk (5-9%) and high risk (> 9%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized uptake value (SUV) of 18F-NaF
The SUV is a validated semi-quantitative assessment of PET radiotracer uptake. The SUV of 18F-NaF will be determined in the aorta, carotid arteries, coronary arteries, iliac arteries and the femoral arteries.
Measured: Up to 7 days after the day of PET CT acquisition
Target to background ratio (TBR) of 18F-NaF
The TBR is a validated semi-quantitative assessment of PET radiotracer uptake. The TBR of 18F-NaF will be determined in the aorta, carotid arteries, coronary arteries, iliac arteries and the femoral arteries.
Measured: Up to 7 days after the day of PET CT acquisition
Secondary outcomes (14)
Standardized uptake value (SUV) of 18F-Fluorodeoxyglucose (18F-FDG)
The SUV is a validated semi-quantitative assessment of PET radiotracer uptake. The SUV of 18F-FDG will be determined in the aorta, carotid arteries, iliac arteries and the femoral arteries.
Measured: Up to 7 days after the day of PET CT acquisition
Target to background ratio (TBR) of 18F-FDG
The TBR is a validated semi-quantitative assessment of PET radiotracer uptake. The TBR of 18F-FDG will be determined in the aorta, carotid arteries, iliac arteries and the femoral arteries.
Measured: Up to 7 days after the day of PET CT acquisition
Correlation between the TBR of 18F-NaF/18F-FDG and traditional cardiovascular risk factors.
The traditional cardiovascular risk factors consist of:
- Smoking, pack years;
- Alcohol, units/week;
- Blood pressure, mean arterial pressure, mmHg;
- Body mass index, kg/m2;
- Waist circumference, cm;
- History of cardiovascular disease;
- Family history of cardiovascular disease;
- Medication usage;
- Age;
- Gender.
Measured: The cardiovascular risk factors will be determined, on average, 1 hour before 18F-NaF / 18F-FDG injection; which ever comes first
Correlation between the TBR of 18F-NaF/18F-FDG and blood markers of atherosclerosis.
Blood markers:
- Total cholesterol, mmol/L;
- LDL cholesterol, mmol/L;
- HDL cholesterol, mmol/L;
- Triglycerides, mmol/L;
- Homocysteine, mmol/L;
- Fasting plasma glucose, mmol/L;
- HBA1c, mmol/mol;
- High sensitivity C-reactive protein, nmol/L;
- Fibrinogen, umol/L;
- Leukocyte differentiation, cells/L;
- Creatinine, umol/L;
Measured: The blood draw will be performed, on average, 1 hour before the 18F-FDG PET CT scan and the blood markers will determined in upto 48 hours after the 18F-FDG PET CT scan
Correlations between 18F-NaF TBR, 18F-FDG TBR, and CT calcification scoring
Correlation between the degree of 18F-NaF uptake, 18F-FDG uptake, CT-Calcification scoring and the various arterial segments (aorta, carotid arteries, iliac arteries and the femoral arteries.
Measured: Up to 7 days after the day of PET CT acquisition
Target to background ratio (TBR) of 18F-NaF
18F-NaF PET/CT images will be acquired at 45, 90 and 180 minutes after intravenous injection of the compound in a subset of 40 patients. The TBR of 18F-NaF will be determined at each time point and compared to allow determining the optimum tracer circulation time for maximum contrast between the vessel wall and blood pool.
Measured: Up to 7 days after the day of PET CT acquisition
Target to background ratio (TBR) of 18F-FDG
18F-FDG PET/CT images will be acquired at 90 and 180 minutes after intravenous injection of the compound in a subset of 40 patients. The TBR of 18F-NaF will be determined at both time points and compared to allow determining the optimum tracer circulation time for maximum contrast between the vessel wall and blood pool.
Measured: Up to 7 days after the day of PET CT acquisition
Correlation between 18F-NaF / 18F-FDG uptake and 18F-FDG uptake in the brain
18F-FDG uptake in the brain will be quantified by calculating the mean and maximum partial-volume corrected SUV.
Measured: Up to 7 days after the day of PET CT acquisition
Correlation between 18F-NaF TBR and 18F-NaF TBR two years after the baseline scan.
The TBR will be determined in various segments of the arterial tree.
Measured: 2 years
Correlation between 18F-FDG TBR and 18F-FDG TBR two years after the baseline scan.
The TBR will be determined in various segments of the arterial tree.
Measured: 2 years
Correlation between the TBR of 18F-NaF/18F-FDG and HeartSCORE
The HeartSCORE will be calculated according to the current HeartSCORE protocol for Denmark.
Measured: Up to 7 days after the day of PET CT acquisition
Correlation between the TBR of 18F-NaF/18F-FDG and Framingham Risk Score
The Framingham Risk Score will be calculated according to the current recommendations by the Framingham Heart Study group
Measured: Up to 7 days after the day of PET CT acquisition
Correlation between 18F-NaF / 18F-FDG uptake and 18F-NaF / 18F-FDG uptake in the vertebral body
18F-NaF uptake in the 1st, 3rd and 5th lumbar vertebral body will be quantified by calculating the mean and maximum partial-volume corrected SUV.
Measured: Up to 7 days after the day of PET CT acquisition
Arterial Calcification Score
Arterial Calcification Scoring will be determined in Agatston Units as well as in volumetric units in all segments of the arterial tree (coronary arteries, aorta, carotid arteries, iliac and femoral arteries.
Measured: Up to 7 days after the day of PET CT acquisition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2014 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Björn A Blomberg, Odense University Hospital
- Investigators
- Poul F Høilund-Carlsen, MD, DMSc, Study chair, Odense University HospitalBjörn A Blomberg, MD, MSc, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724749
- Sponsor's protocol ID
- s-20120056
- Acronym
- CAMONA
- Status last verified
- Nov 2012
- First submitted
- 6 Nov 2012
- Last updated
- 12 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee WK, Patil S, Patel DH, Li Z, Fanta O, Gandhi OH, Werner TJ, Hoilund-Carlsen PF, Alavi A. Automated joint segmentation enables quantitative molecular imaging of degeneration with [(1)(8)F]FDG and [(1)(8)F]NaF PET/CT. Eur J Nucl Med Mol Imaging. 2026 Aug 21. doi: 10.1007/s00259-026-08139-z. Online ahead of print.
PubMed 42625055Patil S, Lee W, Patel R, Gerlach A, Patel D, Kata R, Fanta O, Khan T, Jeevika F, Ayubcha C, Gujral J, Gandhi OH, Werner T, Wulff Christensen H, Hoilund-Carlsen PF, Alavi A. Evaluation of physiological bone metabolic activity in the spine with 18F-fluorodeoxyglucose and 18F-sodium fluoride PET: associations with degenerative risk factors. Nucl Med Commun. 2026 Mar 10. doi: 10.1097/MNM.0000000000002134. Online ahead of print.
PubMed 41805263Patil S, Patel D, Lee W, Patel R, Bhave A, Gujral J, Gandhi OH, Jeevika F, Fanta O, Subtirelu R, Werner TJ, Hoilund-Carlsen PF, Alavi A. Determinants of intracranial microcalcification assessed by 18 F-sodium fluoride PET. Nucl Med Commun. 2026 May 1;47(5):588-593. doi: 10.1097/MNM.0000000000002121. Epub 2026 Feb 19.
PubMed 41709668Patil S, Kata R, Teichner E, Subtirelu R, Ghonim M, Ghonim M, Al-Daoud O, Ismoilov M, Herpin L, Ayubcha C, Werner T, Hoilund-Carlsen PF, Alavi A. Associations of subclinical microcalcification and inflammation with carotid atheroma development: a dual-tracer PET/CT study. Eur J Nucl Med Mol Imaging. 2025 Jun;52(7):2502-2512. doi: 10.1007/s00259-025-07127-z. Epub 2025 Feb 13.
PubMed 39939531Sorci O, Batzdorf AS, Mayer M, Rhodes S, Peng M, Jankelovits AR, Hornyak JN, Gerke O, Hoilund-Carlsen PF, Alavi A, Rajapakse CS. 18F-sodium fluoride PET/CT provides prognostic clarity compared to calcium and Framingham risk scoring when addressing whole-heart arterial calcification. Eur J Nucl Med Mol Imaging. 2020 Jul;47(7):1678-1687. doi: 10.1007/s00259-019-04590-3. Epub 2019 Nov 16.
PubMed 31734781Pourhassan Shamchi S, Khosravi M, Taghvaei R, Zirakchian Zadeh M, Paydary K, Emamzadehfard S, Werner TJ, Hoilund-Carlsen PF, Alavi A. Normal patterns of regional brain 18F-FDG uptake in normal aging. Hell J Nucl Med. 2018 Sep-Dec;21(3):175-180. doi: 10.1967/s002449910902. Epub 2018 Nov 10.
PubMed 30411727
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Molecular Calcification Assessed by 18F-NaF PET CT: The CAMONA Study
- ClinicalTrials.gov ID
- NCT01724749
- Acronym / sponsor ID
- CAMONA / s-20120056
- Conditions
- Cardiovascular Disease, Atherosclerosis, Angina Pectoris
- Keywords
- Atherosclerosis, Sodium-Fluoride, 18F-Sodium Fluoride, 18F-NaF, fluorodeoxyglucose, 18F-FDG, FDG, Positron emission tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 12 Nov 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 purpose of the CAMONA study is to demonstrate the feasibility of cardiovascular molecular calcification (CMC) assessment by means of 18F-sodium-fluoride (18F-NaF) positron emission tomography (PET) computed tomography (CT) in a prospective cohort of healthy control subjects and subjects with cardiovascular disease.
Detailed description
Atherosclerosis associated cardiovascular disease (CVD) remains a significant cause of morbidity and mortality. Asymptomatic individuals with a moderate to high-risk of developing acute atherosclerotic cardiovascular events will benefit most from intensive evidence-based medical interventions.
The traditional approach to identify patients with moderate to high-risk of CVD involves quantifying the presence of CVD risk factors. Based on gender, age, smoking, systolic blood pressure and cholesterol levels, risk stratification algorithms such as the Framingham Risk Score (FRS) and the European SCORE system can predict the 10-year risk of cardiovascular death.
However, these algorithms are associated with several limitations, including misclassification of women and individuals with high levels of a single risk factor. The risk is underestimated in these individuals. Therefore, these individuals are not eligible for treatment by current criteria of CVD prevention guidelines. Several studies indicate that the traditional risk score models leave room for improvement, as they work reasonably well for populations, but remain suboptimal for individual subjects.
New risk parameters are discovered on a regular basis. One of these parameters is cardiovascular molecular calcification (CMC). This entity can be detected and quantified by 18F-NaF PET CT. It has been hypothesized that CMC can be detected years, maybe even decades, before coronary artery calcium scoring (CACS) can be detected by conventional imaging modalities like multislice CT. Theoretically, this tool can detect patients at a very early stage of the disease. Providing evidence-based treatment to these individuals can, theoretically, improve the prevention of CVD. Before this hypothesises can be tested, the feasibility of 18F-NaF PET CT has to be demonstrated in both healthy controls as well as in subjects with cardiovascular disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy control subjects | – | –1. Age: 21 - 80 years 2. No prior history or symptoms of cardiovascular disease The investigators aim to include equal numbers of females and males. Furthermore, the investigators aim to include patients in six different age strata: 21-30, 31-40, 41-50, 51-60, 61-70, 71-80. |
| Subjects with cardiovascular disease | – | –1. Age: 21 - 80 years 2. HeartSCORE > 0% 3. Symptoms of angina pectoris The investigators aim to include equal numbers of females and males. Furthermore, the investigators aim to include patients in six different age strata: 21-30, 31-40, 41-50, 51-60, 61-70, 71-80. Also, the investigators aim to include patients in 3 strata of HeartSCORE risk: low risk (1-4%), mild risk (5-9%) and high risk (> 9%) |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy control subjects will be recruited from a random sample of Danish citizens. To secure timely inclusion of healthy controls, blood donors will be approached for inclusion as well. Subjects with symptoms suggesting angina pectoris will be recruited from the Department of Cardiology, Odense University Hospital. Each patient referred for symptoms suggesting angina pectoris and eligibility for a coronary artery calcium scoring (CACS) will be eligible for inclusion in the investigators study.
Key inclusion criteria (4 listed)
- Age: 21 - 80 years
- Healthy controls: No prior history or symptoms of cardiovascular disease
- Cardiology subjects: Eligibility for CACS due to symptoms suggesting angina pectoris.
- Cardiology subjects: HeartSCORE > 0%.
Key exclusion criteria (10 listed)
- Pregnancy
- Extensive physical activity or extensive partying passed 24 hours
- History of malignant neoplasms with past 5 years
- Known immunodeficiencies
- History of deep vein thrombosis or acute pulmonary embolism within the previous three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Standardized uptake value (SUV) of 18F-NaF
Time frame: Up to 7 days after the day of PET CT acquisition
The SUV is a validated semi-quantitative assessment of PET radiotracer uptake. The SUV of 18F-NaF will be determined in the aorta, carotid arteries, coronary arteries, iliac arteries and the femoral arteries.
Target to background ratio (TBR) of 18F-NaF
Time frame: Up to 7 days after the day of PET CT acquisition
The TBR is a validated semi-quantitative assessment of PET radiotracer uptake. The TBR of 18F-NaF will be determined in the aorta, carotid arteries, coronary arteries, iliac arteries and the femoral arteries.
14 secondary outcomes
Standardized uptake value (SUV) of 18F-Fluorodeoxyglucose (18F-FDG)
Time frame: Up to 7 days after the day of PET CT acquisition
Target to background ratio (TBR) of 18F-FDG
Time frame: Up to 7 days after the day of PET CT acquisition
Correlation between the TBR of 18F-NaF/18F-FDG and traditional cardiovascular risk factors.
Time frame: The cardiovascular risk factors will be determined, on average, 1 hour before 18F-NaF / 18F-FDG injection; which ever comes first
Correlation between the TBR of 18F-NaF/18F-FDG and blood markers of atherosclerosis.
Time frame: The blood draw will be performed, on average, 1 hour before the 18F-FDG PET CT scan and the blood markers will determined in upto 48 hours after the 18F-FDG PET CT scan
Correlations between 18F-NaF TBR, 18F-FDG TBR, and CT calcification scoring
Time frame: Up to 7 days after the day of PET CT acquisition
Target to background ratio (TBR) of 18F-NaF
Time frame: Up to 7 days after the day of PET CT acquisition
Target to background ratio (TBR) of 18F-FDG
Time frame: Up to 7 days after the day of PET CT acquisition
Correlation between 18F-NaF / 18F-FDG uptake and 18F-FDG uptake in the brain
Time frame: Up to 7 days after the day of PET CT acquisition
Correlation between 18F-NaF TBR and 18F-NaF TBR two years after the baseline scan.
Time frame: 2 years
Correlation between 18F-FDG TBR and 18F-FDG TBR two years after the baseline scan.
Time frame: 2 years
Correlation between the TBR of 18F-NaF/18F-FDG and HeartSCORE
Time frame: Up to 7 days after the day of PET CT acquisition
Correlation between the TBR of 18F-NaF/18F-FDG and Framingham Risk Score
Time frame: Up to 7 days after the day of PET CT acquisition
Correlation between 18F-NaF / 18F-FDG uptake and 18F-NaF / 18F-FDG uptake in the vertebral body
Time frame: Up to 7 days after the day of PET CT acquisition
Arterial Calcification Score
Time frame: Up to 7 days after the day of PET CT acquisition
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2012.
- Derived from this study: PubMed 42625055Lee WK, Patil S, Patel DH, Li Z, Fanta O, Gandhi OH, Werner TJ, Hoilund-Carlsen PF, Alavi A. Automated joint segmentation enables quantitative molecular imaging of degeneration with [(1)(8)F]FDG and [(1)(8)F]NaF PET/CT. Eur J Nucl Med Mol Imaging. 2026 Aug 21. doi: 10.1007/s00259-026-08139-z. Online ahead of print.
- Derived from this study: PubMed 41805263Patil S, Lee W, Patel R, Gerlach A, Patel D, Kata R, Fanta O, Khan T, Jeevika F, Ayubcha C, Gujral J, Gandhi OH, Werner T, Wulff Christensen H, Hoilund-Carlsen PF, Alavi A. Evaluation of physiological bone metabolic activity in the spine with 18F-fluorodeoxyglucose and 18F-sodium fluoride PET: associations with degenerative risk factors. Nucl Med Commun. 2026 Mar 10. doi: 10.1097/MNM.0000000000002134. Online ahead of print.
- Derived from this study: PubMed 41709668Patil S, Patel D, Lee W, Patel R, Bhave A, Gujral J, Gandhi OH, Jeevika F, Fanta O, Subtirelu R, Werner TJ, Hoilund-Carlsen PF, Alavi A. Determinants of intracranial microcalcification assessed by 18 F-sodium fluoride PET. Nucl Med Commun. 2026 May 1;47(5):588-593. doi: 10.1097/MNM.0000000000002121. Epub 2026 Feb 19.
- Derived from this study: PubMed 39939531Patil S, Kata R, Teichner E, Subtirelu R, Ghonim M, Ghonim M, Al-Daoud O, Ismoilov M, Herpin L, Ayubcha C, Werner T, Hoilund-Carlsen PF, Alavi A. Associations of subclinical microcalcification and inflammation with carotid atheroma development: a dual-tracer PET/CT study. Eur J Nucl Med Mol Imaging. 2025 Jun;52(7):2502-2512. doi: 10.1007/s00259-025-07127-z. Epub 2025 Feb 13.
- Derived from this study: PubMed 31734781Sorci O, Batzdorf AS, Mayer M, Rhodes S, Peng M, Jankelovits AR, Hornyak JN, Gerke O, Hoilund-Carlsen PF, Alavi A, Rajapakse CS. 18F-sodium fluoride PET/CT provides prognostic clarity compared to calcium and Framingham risk scoring when addressing whole-heart arterial calcification. Eur J Nucl Med Mol Imaging. 2020 Jul;47(7):1678-1687. doi: 10.1007/s00259-019-04590-3. Epub 2019 Nov 16.
- Derived from this study: PubMed 30411727Pourhassan Shamchi S, Khosravi M, Taghvaei R, Zirakchian Zadeh M, Paydary K, Emamzadehfard S, Werner TJ, Hoilund-Carlsen PF, Alavi A. Normal patterns of regional brain 18F-FDG uptake in normal aging. Hell J Nucl Med. 2018 Sep-Dec;21(3):175-180. doi: 10.1967/s002449910902. Epub 2018 Nov 10.
Related trials for Cardiovascular Disease
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
Poul F Høilund-Carlsen, MD, DMSc study chair
Odense University Hospital
Björn A Blomberg, MD, MSc principal investigator
Odense University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease and Atherosclerosis, run by Odense University Hospital at 2 sites in Denmark.
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 10 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: status not confirmed, as of the sponsor's last update on 12 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Poul F Høilund-Carlsen, MD, DMSc (0045 2521 5445, pfhc@ouh.regionsyddanmark.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized uptake value (SUV) of 18F-NaF (time frame: Up to 7 days after the day of PET CT acquisition). The study lists 2 primary outcomes in all. 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 NCT01724749, which also lists 6 linked publications.
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 12 Nov 2012.