Healthy ControlsNCT01546155
The Influence of Pressure Pain on [11C]Diprenorphine Binding Potentials
A study testing PET imaging in people with Healthy Controls, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Healthy volunteers aged 21 to 50 are needed for a research study investigating whether pain will alter the binding properties of ([11C]diprenorphine), a molecule that can be used during brain imaging. Positron Emission Tomography (PET) and functional Magnetic Resonance (fMRI) imaging will be used in this study. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Controls
- What is being tested?
- PET imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female adults, 21 to 50 years of age
- No contraindications to fMRI and PET scanning
- Within 15% of ideal body mass index (BMI)
Who cannot join
- Current significant medical, neurological, or psychiatric illness as assessed by the Physician Investigators
- Women who are pregnant or breast feeding, have gone through menopause, and/or have irregular menstrual cycles
- Claustrophobia
- History of head trauma
- Instability of responses to experimental pain (See Study Procedure Section Part II)
- History of asthma
Show all 10Show fewer
- Use of psychotropic drugs or hormone treatments (including hormonal birth control) within one year of date of consent
- History of smoking
- Routine exercise in excess of one hour per day and/or three times per week
- Non-fluent English speaker
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Charlestown, Massachusetts, 02139
About this study
Healthy volunteers aged 21 to 50 are needed for a research study investigating whether pain will alter the binding properties of ([11C]diprenorphine), a molecule that can be used during brain imaging. Positron Emission Tomography (PET) and functional Magnetic Resonance (fMRI) imaging will be used in this study.
- Conditions
- Healthy Controls
- Being tested
- PET imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET imagingRadiation
Up to a 120 minute PET scan using [11C]diprenorphine as the radiotracer
| Study group | Role | What they receive |
|---|---|---|
| healthy controls | Experimental | Not described Receives: Radiation: PET imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET/MRI Brain Activation
Simultaneously collect fMRI-PET data in humans to investigate the change between bold signal evoked by pressure pain and bold signal evoked by non-painful pressure.
The PET analyses generates one value per 120 minutes. This value is compared to the other 120 minute scan PET value in order to reflect the change.
Measured: day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startDec 2011
- Primary completionOct 2012
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy ControlsStudies of the same condition, open and under way.
- More trials run by Massachusetts General 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Kong, Massachusetts General Hospital
- Investigators
- Jian Kong, MD (equiv), MS, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546155
- Sponsor's protocol ID
- 2011P0022171
- Status last verified
- Jan 2017
- First submitted
- 24 Feb 2012
- Last updated
- 11 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Pressure Pain on [11C]Diprenorphine Binding Potentials
- ClinicalTrials.gov ID
- NCT01546155
- Acronym / sponsor ID
- 2011P0022171
- Conditions
- Healthy Controls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Posted 11 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Healthy volunteers aged 21 to 50 are needed for a research study investigating whether pain will alter the binding properties of ([11C]diprenorphine), a molecule that can be used during brain imaging. Positron Emission Tomography (PET) and functional Magnetic Resonance (fMRI) imaging will be used in this study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy controls | Experimental | Radiation: PET imaging |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and female adults, 21 to 50 years of age
- No contraindications to fMRI and PET scanning
- Within 15% of ideal body mass index (BMI)
Key exclusion criteria (10 listed)
- Current significant medical, neurological, or psychiatric illness as assessed by the Physician Investigators
- Women who are pregnant or breast feeding, have gone through menopause, and/or have irregular menstrual cycles
- Claustrophobia
- History of head trauma
- Instability of responses to experimental pain (See Study Procedure Section Part II)
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 imagingUp to a 120 minute PET scan using [11C]diprenorphine as the radiotracer | Radiation | healthy controls |
Primary outcome
PET/MRI Brain Activation
Time frame: day one
Simultaneously collect fMRI-PET data in humans to investigate the change between bold signal evoked by pressure pain and bold signal evoked by non-painful pressure. The PET analyses generates one value per 120 minutes. This value is compared to the other 120 minute scan PET value in order to reflect the change.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jian Kong, MD (equiv), MS, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET imaging in people with Healthy Controls, run by Massachusetts General Hospital at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 11 Apr 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 11 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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/MRI Brain Activation (time frame: day one). 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 11 Apr 2017.