Rectal PET/MRI: Evaluation of Rectal Cancer Treatment Response Using PET/MRI
Study Details
Study Description
Brief Summary
The investigators will be using the combination of FDG-PET and multiparametric MRI in pre- and post-adjuvant chemoradiation therapy in order to attempt to predict pathologic response on surgical resection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Adjuvant chemotherapy
|
Radiation: Chemoradiation
|
Outcome Measures
Primary Outcome Measures
- change in SUVmax [2 months]
To determine whether percent change in SUVmax correlates with the extent of pathologic primary tumor response
- tumor volume [2 months]
To determine whether percent change in tumor volume correlates with the extent of pathologic primary tumor response
Eligibility Criteria
Criteria
Inclusion Criteria:
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A diagnosis of histopathologically confirmed rectal adenocarcinoma.
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Locally advanced disease as determined by ERUS or pelvic MRI. Endoscopy reports should clearly state both the T and N stage.
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Patients with cT2N1-3M0 or cT2-4NxM0 will be considered eligible for participation.
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Age ≥18.
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Ability to understand a written informed consent document and the willingness to sign it.
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Tumor must be determined to be surgically resectable. Surgical resection is planned to take place at Univeristy of California, San Francisco (UCSF).
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Neoadjuvant chemoradiation prior to resection is planned..
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Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
Exclusion Criteria:
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ERUS tumor state of T1.
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Radiographic evidence of metastatic disease
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Weight in excess of limitations of the scanner or girth that prohibits entry into the bore of the PET/CT scanner due to size.
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Any medical condition which impairs the ability to lie flat and without movement for 15 minutes (e.g. cough, severe arthritis, etc.)
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Prior receipt of any therapy, including local excision, radiation or chemotherapy, for the diagnosed rectal adenocarcinoma.
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Prior history of pelvic radiation.
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Uncontrolled hyperglycemia (defined as inability to achieve a glucose of <250 mg/dL at time of fluorodeoxyglucose (FDG) injection).
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Impaired renal function (CKD 4 or 5: estimated glomerular filtration rate (eGFR) < 30 mLs/min), which is a contraindication to gadolinium containing contrast.
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Known allergy to gadolinium containing contrast agents.
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Contraindication to use of fluoropyrimidines as a radiosensitizing agent.
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Pregnancy or nursing. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to randomization. This is because of the potential teratogenic effects of the involved imaging modalities, radiation, and chemotherapy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCSF Imaging Center at China Basin | San Francisco | California | United States | 94107 |
Sponsors and Collaborators
- University of California, San Francisco
Investigators
- Principal Investigator: Thomas Hope, MD, University of California, San Francisco
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 144513
- NCI-2015-00980