Trial Outcomes & Findings for The Influence of Pressure Pain on [11C]Diprenorphine Binding Potentials (NCT NCT01546155)

NCT ID: NCT01546155

Last Updated: 2017-04-11

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: day one
• Results posted on: 2017-04-11

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	11
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure

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.

Overall Study could not tolerate long scan duration

3

Baseline Characteristics

The Influence of Pressure Pain on [11C]Diprenorphine Binding Potentials

Baseline characteristics by cohort

Measure	Healthy Volunteers n=11 Participants 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.
Age, Continuous	24.1 years STANDARD_DEVIATION 2.7 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Controls n=8 Participants PET imaging: Up to a 120 minute PET scan using \[11C\]diprenorphine as the radiotracer
PET/MRI Brain Activation	0.21 percentage BOLD signal change Standard Deviation 0.13

Adverse Events

Healthy Volunteers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jian Kong

Massachusetts General Hospital

Phone: 617-726-7893

Email: JKONG2@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place