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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| healthy controls | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET imaging | Radiation | Up to a 120 minute PET scan using [11C]diprenorphine as the radiotracer |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | day one |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jian Kong, MD (equiv), MS, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Charlestown | Massachusetts | 02139 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Volunteers | The PET/fMRI scan session will last up to 120 minutes. Subjects will have 2 MR-PET scan sessions, each lasting up to 120 minutes, with a break between scan sessions. Approximately nine venous blood samples will be taken per scan session with a maximum of 48mL of blood drawn per scan session. Intermittent cuff pain, based on the previously determined Strong ratings, will be applied during one of the two scan sessions. Subjects will rate the pain they feel as a result of the cuff stimuli using the Gracely scale. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Volunteers | The PET/fMRI scan session will last up to 120 minutes. Subjects will have 2 MR-PET scan sessions, each lasting up to 120 minutes, with a break between scan sessions. Approximately nine venous blood samples will be taken per scan session with a maximum of 48mL of blood drawn per scan session. Intermittent cuff pain, based on the previously determined Strong ratings, will be applied during one of the two scan sessions. Subjects will rate the pain they feel as a result of the cuff stimuli using the Gracely scale. The additional scan session for subjects will be performed under no pain, "control" conditions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percentage BOLD signal change | day one |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Volunteers | PET imaging: Up to a 120 minute PET scan using [11C]diprenorphine as the radiotracer |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jian Kong | Massachusetts General Hospital | 617-726-7893 | JKONG2@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 11 |
| 0 |
| 11 |
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