Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed,
and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government
operating status and resumption of normal operations can be found at opm.gov.
Evaluation of PET/MRI in Patients With Pancreatic Adenocarcinoma
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
PET/MRI compared to conventional CT and MRI [ Time Frame: Up to several months or longer. Patient will undergo research imaging with each standard of care scan they have. ]
Primary outcome is to determine if the primary tumor and the margins of anatomical land marks from the PET/MRI imaging is more precise and gives a clearer picture of tumor location than standard care, CT or MRI. Both standard of care imaging and this new technology will be compared to the final pathologic analysis, measuring the true distance (in mm) between the primary tumor and margins. Data will be reported as mm.
Secondary Outcome Measures
Resectability post neoadjuvant treatment [ Time Frame: Several months or as deemed a surgical candidate by physician. ]
The secondary outcome is to determine if PET/MRI imaging is better than standard of care imaging (CT or MRI) after patients have received chemotherapy and to determine if they are surgical candidates. The objective is to determine if the primary tumor and the margins of anatomical land marks from the PET/MRI imaging is more precise and gives a clearer picture of tumor location than standard care, CT or MRI. Both standard of care imaging and this new technology will be compared to the final pathologic analysis, measuring the true distance (in mm) between the primary tumor and margins. Data will be reported as mm.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Presence of suspicious lesion of the pancreas consistent with pancreatic adenocarcinoma. Cytological confirmation is not required.
Patients preparing to receive therapy for pancreas cancer, including patients enrolled in NCT01413022
Patient must be 18 years or older
Patient must have a life expectancy of more than 6 months and performance status of 2 or less
Patient must be able to understand and willing to sign an approved written informed consent document
Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the length of the study
Patients enrolled in the Clinical trials.gov# NCT01413022 trial must meet both studies eligibility criteria.
Patient must not have had prior resection for pancreatic adenocarcinoma.
Patient must not have a history of other malignancy less than or equal to 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix
Patient must not be unable to receive a PET-MRI scan due to renal function, allergy or other problem with receiving or tolerating an MRI scan, etc. All patients will fill out a standard MRI screening form.
Patients must not have a blood glucose of greater than or equal to 200mg/dL at the time of PET-MRI or if a patient is diabetic and glucose is not controlled. At the discretion of the PI and the authorized user and with their approval prior to 2-fluoro-2-deoxy-D-glucose (FDG) injection, patients with blood glucose ≥ 200 mg/dL may participate in the study.
Patient must not be pregnant and/or breast feeding