NCT04150705

PET/MR for Rectal Cancer Treatment Monitoring and Surveillance

Terminated NA Results posted Last updated 14 February 2023

What this trial tests

NA trial testing FDG PET/MRI in Rectal Cancer in 14 participants. Terminated before completion.

Timeline

1 June 2020

Primary endpoint
1 September 2022

1 September 2022

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	14
Start date	1 June 2020
Primary completion	1 September 2022
Estimated completion	1 September 2022
Sites	1 location across United States

Drugs / interventions tested

• FDG PET/MRI

Conditions studied

• Rectal Cancer — all drugs for Rectal Cancer →
• Cancer of the Rectum — all drugs for Cancer of the Rectum →

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Rectal Cancer or Cancer of the Rectum. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Technical Feasibility of PET/MRI as Measured by the Completion of the Study With Acceptable Image Quality in ≥70% of Scans Primary · Up to 12 months after completion of enrollment of all patients (26 months)

-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),

Group	Value	95% CI
FDG PET/MRI	95.65

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 Secondary · Up to 12 months after completion of enrollment of all patients (26 months)

* 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

Group	Value	95% CI
FDG PET/MRI	18.18

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected for a period of 24 hours following the administration of the radiotracer FDG.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

FDG PET/MRI

Serious: 0/14 (0%)

Deaths: 0/14

Other adverse events (1 terms — click to expand)

Reaction	System	FDG PET/MRI
Nausea	Gastrointestinal disorders	—

Data from ClinicalTrials.gov NCT04150705 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.