Cancer
Conditions
Brief summary
Researchers are trying to determine the side effects on the heart from immune checkpoint inhibitor (ICI) treatment in patients with cancer.
Interventions
DIAGNOSTIC_TESTPET/CT
Positron emission tomography-computed tomography is an image test that helps show detail about how tissues and organs are functioning.
DRUGradioactive drug (tracer)
A radioactive drug (tracer) is used in the PET scan.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* First time administration of ICI * Willing and able to return in 4-6 weeks for follow-up study * Patients with previous heart conditions included (while this may impact MFR the delta MFR is what we are assessing)
Exclusion criteria
* Age \< 18 years * Women who are pregnant, or breast-feeding. * Unable or unwilling to give consent to undergo PET/CT.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microvascular Damage/Endothelial Dysfunction | 6 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | illness | 2 |
| Overall Study | Pulmonary Issues | 2 |
Baseline characteristics
| Characteristic | Checkpoint Inhibitor (ICI) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 68.17 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 4 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Microvascular Damage/Endothelial Dysfunction
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.
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Checkpoint Inhibitor (ICI) | Microvascular Damage/Endothelial Dysfunction | 0 Participants |