An interventional study of FDG PET/MRI in Rectal Cancer and Cancer of the Rectum, sponsored by Washington University School of Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-14.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Diagnostic
The goal of pilot study is to assess the feasibility of FDG-PET/MRI for monitoring rectal cancer disease status in the setting of rectal cancer non-operative management (NOM). Data from this study will be used to guide the design of future clinical trials involving FDG-PET/MRI for rectal cancer NOM.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 14 is below the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
-Patients will undergo FDG-PET/MRI in lieu of the standard pelvic MRI at up to 6 time-points at which it would normally be performed in their care for the period of time extending 30-36 months from the time of enrollment (depending on enrollment point). In the surveillance period, when patients typically undergo pelvic MRI every 3 months, the FDG-PET/MRI will be done in lieu of the standard pelvic MRI on an approximately every-other-scan basis. In other words, the FDG-PET/MRI will occur roughly once every 6 months.
Device: FDG PET/MRI
-All patients will undergo a simultaneous list mode PET and MR acquisition beginning 55-65 minutes after administration of FDG according to a standard weight-based scale.
Technical Feasibility of PET/MRI as Measured by the Completion of the Study With Acceptable Image Quality in ≥70% of Scans
-For patients imaged at multiple time points after enrollment, all available PET/MRIs will be included in the feasibility analysis. Patients able to remain on the scanner for the full duration of the planned data acquisition without any serious adverse events will be considered to have completed the PET/MRI rectal cancer protocol. Image quality will be assessed by the Principal Investigator on review at a dedicated workstation with specialized PET/MR software. A standardized Likert-based scoring scheme will be utilized to capture subjective assessments of image contrast (1 = worst; 5 = best), image resolution (1 = worst; 5 = best), and image artifact 'freeness' (1 = worst; 5 = best). Image sets scoring ≥ 3 in all three categories will be considered of acceptable quality.
Time frame: Up to 12 months after completion of enrollment of all patients (26 months)
Percentage of Scans With Changes in Perceived Disease Status as Measured by PET/MRI Tumor Regression Grade Relative to the Conventional MRI Only Tumor Regression Grade
* The study reader will interpret the MRI for the tumor regression grade and then will interpret the PET/MRI for the tumor regression grade. * The tumor regression grade is a five-tier imaging-based scoring system based on the ability to distinguish between tumor and fibrosis. mrTRG 1, low signal fibrosis only, no tumor signal; mrTRG 2, more than 75 per cent fibrosis and minimal tumor signal intensity; mrTRG 3, 50 per cent tumor/fibrosis; mrTRG 4, less than 25 per cent fibrosis, predominant tumor signal; and mrTRG 5, no fibrosis
Time frame: Up to 12 months after completion of enrollment of all patients (26 months)
| Milestone | FDG PET/MRI |
|---|---|
| Started | 14 |
| Completed | 14 |
| Not completed | 0 |
-For patients imaged at multiple time points after enrollment, all available PET/MRIs will be included in the feasibility analysis. Patients able to remain on the scanner for the full duration of the planned data acquisition without any serious adverse events will be considered to have completed the PET/MRI rectal cancer protocol. Image quality will be assessed by the Principal Investigator on review at a dedicated workstation with specialized PET/MR software. A standardized Likert-based scoring scheme will be utilized to capture subjective assessments of image contrast (1 = worst; 5 = best), image resolution (1 = worst; 5 = best), and image artifact 'freeness' (1 = worst; 5 = best). Image sets scoring ≥ 3 in all three categories will be considered of acceptable quality.
| percentage of scans that were acceptable | FDG PET/MRI |
|---|---|
| Technical Feasibility of PET/MRI as Measured by the Completion of the Study With Acceptable Image Quality in ≥70% of Scans | 95.65 |
* The study reader will interpret the MRI for the tumor regression grade and then will interpret the PET/MRI for the tumor regression grade. * The tumor regression grade is a five-tier imaging-based scoring system based on the ability to distinguish between tumor and fibrosis. mrTRG 1, low signal fibrosis only, no tumor signal; mrTRG 2, more than 75 per cent fibrosis and minimal tumor signal intensity; mrTRG 3, 50 per cent tumor/fibrosis; mrTRG 4, less than 25 per cent fibrosis, predominant tumor signal; and mrTRG 5, no fibrosis
| percentage of scans | FDG PET/MRI |
|---|---|
| Percentage of Scans With Changes in Perceived Disease Status as Measured by PET/MRI Tumor Regression Grade Relative to the Conventional MRI Only Tumor Regression Grade | 18.18 |
Collected over Adverse events were collected for a period of 24 hours following the administration of the radiotracer FDG.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FDG PET/MRI | 0/14 (0%) | 0/14 (0%) | 2/14 (14.3%) |
| Event | FDG PET/MRI |
|---|---|
| NauseaGastrointestinal disorders | 2/14 |
| Age, Continuous(years) | FDG PET/MRI |
|---|---|
| Median | 51.6 (38.4 to 83.3) |
| Sex: Female, Male(Participants) | FDG PET/MRI |
|---|---|
| Female | 7 |
| Male | 7 |
| Ethnicity (NIH/OMB)(Participants) | FDG PET/MRI |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 14 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | FDG PET/MRI |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 13 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | FDG PET/MRI |
|---|---|
| United States | 14 |
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Washington University School of Medicine