PET/MR for Rectal Cancer Treatment Monitoring and Surveillance

Rectal Cancer Clinical Trial

Official title:

A Pilot Study of PET/MR for Rectal Cancer Treatment Monitoring and Surveillance

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04150705
• Other study ID #: 201908228
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: February 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Cancer of the Rectum
• Rectal Cancer
• Rectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 12 months after completion of enrollment of all patients (26 months)
Secondary	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	Up to 12 months after completion of enrollment of all patients (26 months)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine