PET/MR for Rectal Cancer Treatment Monitoring and Surveillance

The Washington University

Status: Terminated

Conditions: Cancer of the Rectum; Rectal Cancer

Treatments: Device: FDG PET/MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT04150705

201908228

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

FDG PET/MRI

Experimental group

Description:

-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.

Treatment:

Device: FDG PET/MRI