Intestinal FDG Uptake
Conditions
Brief summary
Patients who undergo PET-CT scans to look for cancer are given an intravenous contrast (FDG) that is taken-up by active cells such as cancer cells. This contrast can then be seen in the body using the PET-CT scanner. However, cells in the colon also take up the FDG, and can produce false positive signals from the colon. Our hypothesis is that much of this signal comes from bacteria that are present in high concentrations in the colon. If this is the case, using an antibiotic to suppress the activity of bacteria may improve the ability of PET-CT to distinguish abnormal cells from normal cells in the colon.
Interventions
DRUGRifaximin
550mg BID for 2 days
Sponsors
Bausch Health Americas, Inc.
Beth Israel Deaconess Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing clinically-indicated PET-CT scan for non-GI lymphoma
Exclusion criteria
* Patients with known Inflammatory Bowel Disease * Patients with known colon cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SUVmax of FDG in Each Colonic Segment | Day 2 |
Secondary
| Measure | Time frame |
|---|---|
| SUVavg in Each Colonic Segment | Day 2 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rifaximin Rifaximin: 550mg BID for 2 days | 38 |
| Control Randomly-selected matched PET-CT scans performed on same day as intervention group. | 30 |
| Total | 68 |
Baseline characteristics
| Characteristic | Rifaximin | Control | Total |
|---|---|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 19 | 56 years STANDARD_DEVIATION 19 | 56 years STANDARD_DEVIATION 19 |
| Region of Enrollment United States | 38 participants | 30 participants | 68 participants |
| Sex: Female, Male Female | 17 Participants | 15 Participants | 32 Participants |
| Sex: Female, Male Male | 21 Participants | 15 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
SUVmax of FDG in Each Colonic Segment
Time frame: Day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rifaximin | SUVmax of FDG in Each Colonic Segment | 4.6 SUV | Standard Deviation 2.3 |
| Control | SUVmax of FDG in Each Colonic Segment | 4.3 SUV | Standard Deviation 2.7 |
Secondary
SUVavg in Each Colonic Segment
Time frame: Day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rifaximin | SUVavg in Each Colonic Segment | 1.6 SUV | Standard Deviation 0.9 |
| Control | SUVavg in Each Colonic Segment | 1.8 SUV | Standard Deviation 0.9 |