Determining if a PET/MRI can predict complete response from chemoradiotherapy before surgery in patients with locally advanced rectal cancer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-009170
Sponsor Protocol Number: 15-009170
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