PET/MR for Rectal Cancer Treatment Monitoring and Surveillance

Not Applicable

Terminated

• Conditions: Cancer of the Rectum; Rectal Cancer
• Interventions: Device: FDG PET/MRI

• Registration Number: NCT04150705
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-10-31
• Study First Posted: 2019-11-05
• Study Start: 2020-06-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01
• Results First Submitted: 2022-12-15
• Results First Submitted QC: 2023-01-17
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-12
• Results First Posted: 2023-02-13
• Last Update Posted: 2023-02-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• At least 18 years of age
• Biopsy-proven rectal adenocarcinoma of the rectum with clinically suspected or previously known stage I-IIIB (cT1-4, N0-2, M0) disease
• Anticipated or prior chemoradiation as part of an NOM treatment strategy
• Ability to understand and willingness to sign an IRB-approved written informed consent document

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Exclusion Criteria

• Prior surgical resection of rectal cancer (endoscopic or TME)
• Contraindication to MRI
• Comorbidities that would limit patient's ability to cooperate with a PET/MRI examination (e.g. dementia, inability to follow commands, claustrophobia, tremors, requirement for oxygen by nasal cannula, etc...).
• Implanted devices or materials that may interfere with MRI imaging or create significant artifact
• Pregnancy
• Contraindication to gadolinium contrast or FDG
• End-stage renal disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FDG PET/MRI	FDG PET/MRI	-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.

Primary Outcome Measures

Name	Time	Method
Technical Feasibility of PET/MRI as Measured by the Completion of the Study With Acceptable Image Quality in ≥70% of Scans	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), 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.

Secondary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States