Trial Outcomes & Findings for Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Detecting Lactate and Bicarbonate in Participants With Central Nervous System Tumors (NCT NCT03565367)
NCT ID: NCT03565367
Last Updated: 2023-12-21
Results Overview
The measurement of this drug is the number of participants with Grade 2 or higher related adverse events (except for asymptomatic lab increases)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
2 days (+/-2) after the scan
Results posted on
2023-12-21
Participant Flow
Participant milestones
| Measure |
Healthy Volunteers
Participants undergo MRI over 45 minutes at baseline, then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes.
|
Known CNS Malignancy
Participants undergo MRI over 45 minutes at baseline, then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes (participants may receive gadolinium at the discretion of the protocol director).
|
|---|---|---|
|
Overall Study
Received Interventions
|
3
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
STARTED
|
7
|
2
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Healthy Volunteers
Participants undergo MRI over 45 minutes at baseline, then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes.
|
Known CNS Malignancy
Participants undergo MRI over 45 minutes at baseline, then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes (participants may receive gadolinium at the discretion of the protocol director).
|
|---|---|---|
|
Overall Study
No scan due to technical issues
|
4
|
0
|
Baseline Characteristics
Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Detecting Lactate and Bicarbonate in Participants With Central Nervous System Tumors
Baseline characteristics by cohort
| Measure |
Healthy Volunteers
n=3 Participants
Participants undergo MRI over 45 minutes at baseline, then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes.
|
Known CNS Malignancy
n=2 Participants
Participants undergo MRI over 45 minutes at baseline, then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes (participants may receive gadolinium at the discretion of the protocol director).
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 days (+/-2) after the scanThe measurement of this drug is the number of participants with Grade 2 or higher related adverse events (except for asymptomatic lab increases)
Outcome measures
| Measure |
Healthy Volunteers
n=3 Participants
Participants undergo MRI over 45 minutes at baseline, then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes.
|
Known CNS Malignancy
n=2 Participants
Participants undergo MRI over 45 minutes at baseline, then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes (participants may receive gadolinium at the discretion of the protocol director).
|
|---|---|---|
|
Number of Participants With Grade 2 or Higher Toxicities
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Imaging timepoint (up to 15 minutes to obtain scan)The outcome is defined as the number of participants with hyperpolarized carbon C 13 pyruvate magnetic resonance signal detection above background noise level of both lactate and bicarbonate in all tumors screened.
Outcome measures
Outcome data not reported
Adverse Events
Known CNS Malignancy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Volunteers
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Known CNS Malignancy
n=2 participants at risk
Participants undergo MRI over 45 minutes at baseline, then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes (participants may receive gadolinium at the discretion of the protocol director).
|
Healthy Volunteers
n=3 participants at risk
Participants undergo MRI over 45 minutes at baseline, then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes.
|
|---|---|---|
|
Nervous system disorders
Anosmia
|
0.00%
0/2 • Up to 4 days
|
33.3%
1/3 • Up to 4 days
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/2 • Up to 4 days
|
33.3%
1/3 • Up to 4 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place