Nuclear MedicineNCT06180200
Study of the in Vivo Expression of MU Opioid Receptors Using PET and the Selective Tracer [C-11] Carfentanil in Normal Weight and Obese Subjects
An observational study of Nuclear Medicine, run by IRCCS San Raffaele.
Trial summary
Positron emission tomography (PET) is a nuclear medicine technique that allows the measurement, in vivo in humans, with a non-invasive method, of the regional distribution of substances marked with positron emission isotopes such as C-11, in different districts bodily. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Nuclear Medicine
- What is being tested?
- PET for the analysis of mu opioid receptor expression.
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 22 Oct 2004to 1 Dec 2007
- 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 40 years
- Men only
- Adult
Study population: For the study, 10 normal male subjects and 10 obese subjects not affected by mental or physical pathological alterations will be recruited.
Who may be able to join
- aged between 18 and 40 years;
- structured sports activity < 2 hours per week
Who cannot join
- drug allergy;
- clinical evidence of neuropsychiatric pathologies.
About this study
Positron emission tomography (PET) is a nuclear medicine technique that allows the measurement, in vivo in humans, with a non-invasive method, of the regional distribution of substances marked with positron emission isotopes such as C-11, in different districts bodily. Using this method it is therefore possible to directly measure at the level of the brain the distribution of receptors, enzymes, reuptake sites, as well as their interaction with various classes of drugs and the related modifications that may be present during the pathology.
The evaluation of the endogenous opiate receptor system will be implemented by comparing the in vivo binding maps of 11C carfentanil in the two groups of subjects under examination (normal weight, NOR and obese, OB, based on body mass index, BMI); in fact, experimental data deriving from previous studies support the hypothesis that the basis of obesity and incorrect eating behaviors is a dysregulation of the endogenous ligand-mu opioid receptor interaction. The comparison of the data deriving from the analysis of the PET exams performed on the two groups of subjects will therefore allow us to evaluate the alterations of the opioid system possibly present in obese subjects.
- Conditions
- Nuclear Medicine
- Being tested
- PET for the analysis of mu opioid receptor expression.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET for the analysis of mu opioid receptor expression.Diagnostic test
PET for the analysis of the expression of mu opioid receptors and to directly measure the distribution of the receptors and enzyme reuptake sites at the brain level.
What is being measured
The primary outcome is the main question the study is designed to answer.
PET with 11C CARFENTANIL for the analysis of the expression of mu opioid receptors.
Study of the expression of mu opioid receptors in normal weight and obese subjects
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start22 Oct 2004
- Primary completion1 Dec 2007
- Study completion1 Dec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nuclear MedicineStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiti Arturo, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180200
- Sponsor's protocol ID
- CARF-2
- Status last verified
- Mar 2024
- First submitted
- 12 Dec 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the in Vivo Expression of MU Opioid Receptors Using PET and the Selective Tracer [C-11] Carfentanil in Normal Weight and Obese Subjects
- ClinicalTrials.gov ID
- NCT06180200
- Acronym / sponsor ID
- CARF-2
- Conditions
- Nuclear Medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 22 Oct 2004 (actual)
- Primary completion
- 1 Dec 2007 (actual)
- Study completion
- 1 Dec 2007 (actual)
- First posted
- 22 Dec 2023 (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.
Positron emission tomography (PET) is a nuclear medicine technique that allows the measurement, in vivo in humans, with a non-invasive method, of the regional distribution of substances marked with positron emission isotopes such as C-11, in different districts bodily. Using this method it is therefore possible to directly measure at the level of the brain the distribution of receptors, enzymes, reuptake sites, as well as their interaction with various classes of drugs and the related modifications that may be present during the pathology.
The evaluation of the endogenous opiate receptor system will be implemented by comparing the in vivo binding maps of 11C carfentanil in the two groups of subjects under examination (normal weight, NOR and obese, OB, based on body mass index, BMI); in fact, experimental data deriving from previous studies support the hypothesis that the basis of obesity and incorrect eating behaviors is a dysregulation of the endogenous ligand-mu opioid receptor interaction. The comparison of the data deriving from the analysis of the PET exams performed on the two groups of subjects will therefore allow us to evaluate the alterations of the opioid system possibly present in obese subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- For the study, 10 normal male subjects and 10 obese subjects not affected by mental or physical pathological alterations will be recruited.
Key inclusion criteria (2 listed)
- aged between 18 and 40 years;
- structured sports activity < 2 hours per week
Key exclusion criteria (2 listed)
- drug allergy;
- clinical evidence of neuropsychiatric pathologies.
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 |
|---|---|---|
| PET for the analysis of mu opioid receptor expression.PET for the analysis of the expression of mu opioid receptors and to directly measure the distribution of the receptors and enzyme reuptake sites at the brain level. | Diagnostic test | – |
Primary outcome
PET with 11C CARFENTANIL for the analysis of the expression of mu opioid receptors.
Time frame: 3 years
Study of the expression of mu opioid receptors in normal weight and obese subjects
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 6 Mar 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Nuclear Medicine, run by IRCCS San Raffaele.
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 2 inclusion and 2 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 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
PET with 11C CARFENTANIL for the analysis of the expression of mu opioid receptors. (time frame: 3 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 6 Mar 2024.