Metabolic PreparationNCT04437927
Impact of 100mL Lipid Emulsion for Intravenous for Suppression of Myocardial Glucose Metabolism in 18F-FDG PET/CT
An observational study of Metabolic Preparation and Myocardial Inflammation, run by Centre Hospitalier Princesse Grace at 1 site in Monaco.
Trial summary
There is increasing evidence that [18F]-2-fluoro-2-deoxy-D-glucose (18F-FDG) PET/CT is useful in the identification and treatment of disease processes that involve cardiac inflammation and infection. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Metabolic Preparation, Myocardial Inflammation
- How many people
- 51 participants
- Where
- 1 siteMonaco
- Study dates
- 7 Apr 2020to 6 Nov 2020
- How long will I take part?
- 1 Day
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Group of 30 consecutive patients with cardiac FDG PET prescribed, prospectively enrolled, compared to a group with the last 30 patients referred for cardiac FDG PET.
Who may be able to join
- Patients with an FDG PET/CT prescribed to explore cardiac disease process
Who cannot join
- renal insufficiency,
- uncompensated diabetes mellitus,
- pancreatitis,
- liver insufficiency,
- hypothyroidism
- metabolic disorders
- sepsis.
- soy protein allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of 100mL Lipid Emulsion for Intravenous for Suppression of Myocardial Glucose
There is increasing evidence that [18F]-2-fluoro-2-deoxy-D-glucose (18F-FDG) PET/CT is useful in the identification and treatment of disease processes that involve cardiac inflammation and infection. Current applications include imaging intra-cardiac device and prosthetic valve infections, evaluating patients with known or suspected cardiac sarcoidosis or other inflammatory cardiomyopathies.
However, because normal myocardium can metabolize both glucose and free fatty acids (FFAs), physiological accumulation of FDG in the myocardium can interfere with the recognition of abnormal FDG uptake.
Read more
The use of a low-carbohydrate diet with a prolonged fast ≥ 12 h nutrition followed by a fast of at least four hours is the effective preparation recommended to suppress physiological myocardial FDG uptake.
However, the rate of suppression of physiological accumulation of FDG with this method in our center is only 50%.
Read the detailed description
Methodology :
Group of 30 consecutive patients with cardiac FDG PET prescribed, prospectively enrolled, compared to a group with the last 30 patients referred for cardiac FDG PET in the nuclear medicine department of the Centre Hospitalier Princesse Grace.
Procedures :
Infusion of 100mL lipid emulsion for intravenous two hours before cardiac FDG PET/CT:
- Infusion rate will be 20 mL/hour during the initial 10 minutes (3 mL Intralipid)
- The dose will be then increased to 40 mL/hour for the next 10 minutes (6 mL Intralipid)
- Finally, for the next 50 minutes the dose will be increased to 100 mL/hour (83mL Intralipid)
- Conditions
- Metabolic Preparation, Myocardial Inflammation
- Medical subject headings
- Myocarditis
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 |
|---|---|---|
| Prospective patients | 30 consecutive patients with cardiac FDG PET prescribed | |
| Control | 30 patients referred for cardiac FDG PET in the nuclear medicine department of the Centre Hospitalier Princesse Grace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake in the heart scoring according to a visual scale
- Score of 0: complete myocardial suppression
- Score of 1: incomplete myocardial suppression with increased myocardial FDG uptake hampering myocardial interpretation but not cardiac valves.
- Score of 2: incomplete myocardial suppression with increased myocardial FDG uptake hampering myocardial and mitral or aortic valve interpretations.
- Score of 3: incomplete myocardial suppression with increased myocardial FDG uptake hampering myocardial and both mitral and aortic valves interpretations.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start7 Apr 2020
- Primary completion6 Nov 2020
- Study completion6 Nov 2020
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 Metabolic PreparationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Princesse Grace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437927
- Sponsor's protocol ID
- 20-11
- Status last verified
- Jun 2020
- First submitted
- 16 Jun 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dietz M, Paulmier B, Berthier F, Civaia F, Mocquot F, Serrano B, Nataf V, Hugonnet F, Faraggi M. An Intravenous 100-mL Lipid Emulsion Infusion Dramatically Improves Myocardial Glucose Metabolism Extinction in Cardiac FDG PET Clinical Practice. Clin Nucl Med. 2021 Jun 1;46(6):e317-e324. doi: 10.1097/RLU.0000000000003556.
PubMed 33630808
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of 100mL Lipid Emulsion for Intravenous for Suppression of Myocardial Glucose
- ClinicalTrials.gov ID
- NCT04437927
- Acronym / sponsor ID
- 20-11
- Conditions
- Metabolic Preparation, Myocardial Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Centre Hospitalier Princesse GraceUniversity, hospital or other
- Study start
- 7 Apr 2020 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 18 Jun 2020 (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.
There is increasing evidence that [18F]-2-fluoro-2-deoxy-D-glucose (18F-FDG) PET/CT is useful in the identification and treatment of disease processes that involve cardiac inflammation and infection. Current applications include imaging intra-cardiac device and prosthetic valve infections, evaluating patients with known or suspected cardiac sarcoidosis or other inflammatory cardiomyopathies.
However, because normal myocardium can metabolize both glucose and free fatty acids (FFAs), physiological accumulation of FDG in the myocardium can interfere with the recognition of abnormal FDG uptake.
The use of a low-carbohydrate diet with a prolonged fast ≥ 12 h nutrition followed by a fast of at least four hours is the effective preparation recommended to suppress physiological myocardial FDG uptake.
However, the rate of suppression of physiological accumulation of FDG with this method in our center is only 50%.
Detailed description
Methodology :
Group of 30 consecutive patients with cardiac FDG PET prescribed, prospectively enrolled, compared to a group with the last 30 patients referred for cardiac FDG PET in the nuclear medicine department of the Centre Hospitalier Princesse Grace.
Procedures :
Infusion of 100mL lipid emulsion for intravenous two hours before cardiac FDG PET/CT:
- Infusion rate will be 20 mL/hour during the initial 10 minutes (3 mL Intralipid)
- The dose will be then increased to 40 mL/hour for the next 10 minutes (6 mL Intralipid)
- Finally, for the next 50 minutes the dose will be increased to 100 mL/hour (83mL Intralipid)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective patients | – | –30 consecutive patients with cardiac FDG PET prescribed |
| Control | – | –30 patients referred for cardiac FDG PET in the nuclear medicine department of the Centre Hospitalier Princesse Grace |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Group of 30 consecutive patients with cardiac FDG PET prescribed, prospectively enrolled, compared to a group with the last 30 patients referred for cardiac FDG PET.
Key inclusion criteria (1 listed)
- Patients with an FDG PET/CT prescribed to explore cardiac disease process
Key exclusion criteria (8 listed)
- renal insufficiency,
- uncompensated diabetes mellitus,
- pancreatitis,
- liver insufficiency,
- hypothyroidism
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
Uptake in the heart scoring according to a visual scale
Time frame: day 1
* Score of 0: complete myocardial suppression * Score of 1: incomplete myocardial suppression with increased myocardial FDG uptake hampering myocardial interpretation but not cardiac valves. * Score of 2: incomplete myocardial suppression with increased myocardial FDG uptake hampering myocardial and mitral or aortic valve interpretations. * Score of 3: incomplete myocardial suppression with increased myocardial FDG uptake hampering myocardial and both mitral and aortic valves interpretations.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Derived from this study: PubMed 33630808Dietz M, Paulmier B, Berthier F, Civaia F, Mocquot F, Serrano B, Nataf V, Hugonnet F, Faraggi M. An Intravenous 100-mL Lipid Emulsion Infusion Dramatically Improves Myocardial Glucose Metabolism Extinction in Cardiac FDG PET Clinical Practice. Clin Nucl Med. 2021 Jun 1;46(6):e317-e324. doi: 10.1097/RLU.0000000000003556.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Preparation and Myocardial Inflammation, run by Centre Hospitalier Princesse Grace at 1 site in Monaco.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 9 Nov 2020. 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 Monaco. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Uptake in the heart scoring according to a visual scale (time frame: day 1). 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 NCT04437927, 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 9 Nov 2020.