Trial Outcomes & Findings for Feasibility - Infinitome (NCT NCT04563767)
NCT ID: NCT04563767
Last Updated: 2021-02-17
Results Overview
Percent of subjects who complete the sequence of the fMRI protocol. Range: 0-100. Higher percentage indicates more completion.
Recruitment status
COMPLETED
Target enrollment
4 participants
Primary outcome timeframe
4 months
Results posted on
2021-02-17
Participant Flow
Participant milestones
| Measure |
Infinitome
All patients will be in the same cohort. No intervention will be administered. Patients will undergo a structural magnetic resonance imaging (MRI) as part of their standard of care. Added on will be the resting state fMRI (rs-fMRI). The rs-fMRI data will be analyzed.
Infinitome: Added sequence of rs-fMRI.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Infinitome
n=4 Participants
All patients will be in the same cohort. No intervention will be administered. Patients will undergo a structural magnetic resonance imaging (MRI) as part of their standard of care. Added on will be the resting state fMRI (rs-fMRI). The rs-fMRI data will be analyzed.
Infinitome: Added sequence of rs-fMRI.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPercent of subjects who complete the sequence of the fMRI protocol. Range: 0-100. Higher percentage indicates more completion.
Outcome measures
| Measure |
Infinitome
n=4 Participants
All patients will be in the same cohort. No intervention will be administered. Patients will undergo a structural magnetic resonance imaging (MRI) as part of their standard of care. Added on will be the resting state fMRI (rs-fMRI). The rs-fMRI data will be analyzed.
Infinitome: Added sequence of rs-fMRI.
|
|---|---|
|
Number of Participants Who Completed Rs-fMRI
|
4 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPercent of subjects whose images were uploaded and analyzed by the Infinitome program. Range: 0-100. Higher percentage indicates more completion.
Outcome measures
| Measure |
Infinitome
n=4 Participants
All patients will be in the same cohort. No intervention will be administered. Patients will undergo a structural magnetic resonance imaging (MRI) as part of their standard of care. Added on will be the resting state fMRI (rs-fMRI). The rs-fMRI data will be analyzed.
Infinitome: Added sequence of rs-fMRI.
|
|---|---|
|
Number of Subjects Whose Images Completed Analysis
|
4 Participants
|
Adverse Events
Infinitome
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place