Determining if a PET/MRI can predict complete response from chemoradiotherapy before surgery in patients with locally advanced rectal cancer

Overview

About this study

To determine whether PET/MRI can accurately predict complete pathologic response from neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Histologically confirmed primary adenocarcinoma, clinical Stage II disease (T3-4, N0) or Stage III disease (any T, N1-2)
  • No known distant metastatic disease at initial staging
  • Patients for whom the interdisciplinary treatment team has selected standard CRT followed by TME as the treatment plan
  • Pre-treatment staging MRI available
  • Blood sugar levels less than 200 mg/dl at the time of the exam
  • A negative pregnancy test is required for female subjects of child-bearing potential within 48 hours of F-18 FDG injection
  • Informed consent for dual modality PET/MRI without IV contrast material
  • Age greater than 18, male or female

Exclusion Criteria

  • No available initial staging MR exam.
  • Any contraindication for MRI, including pacemakers, aneurysm clips, cochlear implants, and certain spinal stimulation devices.
  • Subjects with a metallic prosthesis in the pelvis that may interfere with the MR and PET imaging.
  • Nonsurgical candidates.
  • Patients with uncontrolled diabetes.
  • Patients with known distant metastatic disease (M1) at the time of initial staging.
  • Patients with evidence of mucinous subtype of adenocarcinoma on biopsy and/or on initial staging MR exam.
  • Prior pelvic radiation.
  • Prior chemotherapy or surgery for rectal cancer.
  • Patients in whom neoadjuvant therapy is contraindicated.
  • Female subjects who are breast-feeding or with a positive pregnancy test.
  • Patients with a known history of claustrophobia.
  • Subjects unable to provide informed consent.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Shannon Sheedy, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20304179

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