Evaluation of Rectal Cancer Treatment Response Using PET/MRI
Terminated
- Conditions
- Rectal Adenocarcinoma
- Registration Number
- NCT02233595
- Lead Sponsor
- University of California, San Francisco
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 7
Inclusion Criteria
- A diagnosis of histopathologically confirmed rectal adenocarcinoma.
- Locally advanced disease as determined by ERUS or pelvic MRI. Endoscopy reports should clearly state both the T and N stage.
- Patients with cT2N1-3M0 or cT2-4NxM0 will be considered eligible for participation.
- Age ≥18.
- Ability to understand a written informed consent document and the willingness to sign it.
- Tumor must be determined to be surgically resectable. Surgical resection is planned to take place at Univeristy of California, San Francisco (UCSF).
- Neoadjuvant chemoradiation prior to resection is planned..
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
Exclusion Criteria
- ERUS tumor state of T1.
- Radiographic evidence of metastatic disease
- Weight in excess of limitations of the scanner or girth that prohibits entry into the bore of the PET/CT scanner due to size.
- Any medical condition which impairs the ability to lie flat and without movement for 15 minutes (e.g. cough, severe arthritis, etc.)
- Prior receipt of any therapy, including local excision, radiation or chemotherapy, for the diagnosed rectal adenocarcinoma.
- Prior history of pelvic radiation.
- Uncontrolled hyperglycemia (defined as inability to achieve a glucose of <250 mg/dL at time of fluorodeoxyglucose (FDG) injection).
- Impaired renal function (CKD 4 or 5: estimated glomerular filtration rate (eGFR) < 30 mLs/min), which is a contraindication to gadolinium containing contrast.
- Known allergy to gadolinium containing contrast agents.
- Contraindication to use of fluoropyrimidines as a radiosensitizing agent.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UCSF Imaging Center at China Basin
🇺🇸San Francisco, California, United States
UCSF Imaging Center at China Basin🇺🇸San Francisco, California, United States