Trial Outcomes & Findings for PET/CT Quantitative Assessment of Myocardial Blood Flow Changes in Oncologic Patients Receiving Checkpoint Inhibitor Therapy (NCT NCT04538950)
NCT ID: NCT04538950
Last Updated: 2023-09-13
Results Overview
Number of subjects to develop microvascular damage/endothelial dysfunction as determined by the PET/CT scan. PET-CT MFR used to assess dynamic changes in MFR that occur pre and post initiation of ICI and thereby potentially identify early cardiotoxicity in patients who might be more prone to more devastating IRAEs such as myocarditis.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
6 participants
Primary outcome timeframe
6 weeks
Results posted on
2023-09-13
Participant Flow
Participant milestones
| Measure |
Checkpoint Inhibitor (ICI)
Subjects diagnosed with cancer and will be receiving immune checkpoint inhibitors as treatment standard of care will have a PET/CT scan before and after therapy. PET/CT scan is done for study purposes only.
PET/CT: Positron emission tomography-computed tomography is an image test that helps show detail about how tissues and organs are functioning.
radioactive drug (tracer): A radioactive drug (tracer) is used in the PET scan.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Checkpoint Inhibitor (ICI)
Subjects diagnosed with cancer and will be receiving immune checkpoint inhibitors as treatment standard of care will have a PET/CT scan before and after therapy. PET/CT scan is done for study purposes only.
PET/CT: Positron emission tomography-computed tomography is an image test that helps show detail about how tissues and organs are functioning.
radioactive drug (tracer): A radioactive drug (tracer) is used in the PET scan.
|
|---|---|
|
Overall Study
Pulmonary Issues
|
2
|
|
Overall Study
illness
|
2
|
Baseline Characteristics
PET/CT Quantitative Assessment of Myocardial Blood Flow Changes in Oncologic Patients Receiving Checkpoint Inhibitor Therapy
Baseline characteristics by cohort
| Measure |
Checkpoint Inhibitor (ICI)
n=6 Participants
Subjects diagnosed with cancer and will be receiving immune checkpoint inhibitors as treatment standard of care will have a PET/CT scan before and after therapy. PET/CT scan is done for study purposes only.
PET/CT: Positron emission tomography-computed tomography is an image test that helps show detail about how tissues and organs are functioning.
radioactive drug (tracer): A radioactive drug (tracer) is used in the PET scan.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
|
Age, Continuous
|
68.17 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 6 weeksNumber of subjects to develop microvascular damage/endothelial dysfunction as determined by the PET/CT scan. PET-CT MFR used to assess dynamic changes in MFR that occur pre and post initiation of ICI and thereby potentially identify early cardiotoxicity in patients who might be more prone to more devastating IRAEs such as myocarditis.
Outcome measures
| Measure |
Checkpoint Inhibitor (ICI)
n=2 Participants
Subjects diagnosed with cancer and will be receiving immune checkpoint inhibitors as treatment standard of care will have a PET/CT scan before and after therapy. PET/CT scan is done for study purposes only.
PET/CT: Positron emission tomography-computed tomography is an image test that helps show detail about how tissues and organs are functioning.
radioactive drug (tracer): A radioactive drug (tracer) is used in the PET scan.
|
|---|---|
|
Microvascular Damage/Endothelial Dysfunction
|
0 Participants
|
Adverse Events
Checkpoint Inhibitor (ICI)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Checkpoint Inhibitor (ICI)
n=6 participants at risk
Subjects diagnosed with cancer and will be receiving immune checkpoint inhibitors as treatment standard of care will have a PET/CT scan before and after therapy. PET/CT scan is done for study purposes only.
PET/CT: Positron emission tomography-computed tomography is an image test that helps show detail about how tissues and organs are functioning.
radioactive drug (tracer): A radioactive drug (tracer) is used in the PET scan.
|
|---|---|
|
Infections and infestations
Moderate Sepsis
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 6 weeks on all participants.
|
|
Gastrointestinal disorders
Mild vomiting
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 6 weeks on all participants.
|
|
Cardiac disorders
Moderate chest pain
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 6 weeks on all participants.
|
|
Cardiac disorders
Mild atrial fibrillation
|
33.3%
2/6 • Number of events 2 • Adverse events were collected from baseline to end of study participation for a total of approximately 6 weeks on all participants.
|
|
Gastrointestinal disorders
Mild Ileus
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 6 weeks on all participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place