Disposable Perfusion Phantom for Accurate DCE-MRI Measurement of Pancreatic Cancer Therapy Response
Disposable Perfusion Phantom for Accurate DCE-MRI Measurement of Pancreatic Cancer Therapy Response
This trial tests the use of a disposable perfusion phantom (P4) to decrease errors in calculating the blood flow of a tissue with DCE-MRI. DCE-MRI is used calculate blood flow of various tissues including tumors. Blood flow often serves as a critical indicator showing a disease status. For example, a pancreatic tumor has typically low blood flow, so it can be used as an indicator to identify the presence of a pancreatic tumor. In addition, an effective therapy may result in the increase of blood flow in a pancreatic tumor during the early period of treatment. Therefore, DCE-MRI may be used to determine whether the undergoing therapy is effective or not by measuring the change of blood flow in the pancreatic tumor and may help doctors decide whether to continue the therapy or try a different one. Unfortunately, the measurement of blood flow using DCE-MRI is not accurate. The use of an artificial tissue, named "phantom" or P4, together with a patient may help to reduce errors in DCE-MRI because errors will affect the images of both the patient and the phantom. Because it is known how the blood flow of the phantom appears when no errors are present, the phantom may be used to detect what kinds of errors are present in the image, how many errors are present in the image, and how to remove errors from the image.
Pancreatic
N/A
Adults
Not Available
Not Available
Xu, Junzhong
Local
Vanderbilt University
10-08-2020
Diagnostic
VICCGI2099
NCT04588025
Eligibility
19 Years
BOTH
YES
Inclusion Criteria:
HEALTHY VOLUNTEERS: No major health problems including but not limited to cancers, heart diseases, diabetes, high blood pressure and/or cholesterol, stroke, respiratory problems, and arthritis
HEALTHY VOLUNTEERS: Participants with signed informed consent
PATIENTS: Patients with newly diagnosed and untreated locally advanced pancreatic cancer
PATIENTS: Patients with signed informed consent
PATIENTS: Patients will be treated with standard-of-care first-line therapeutic regimens including gemcitabine such as nab-paclitaxel, fluorouracil, irinotecan, leucovorin and oxaliplatin (FOLFIRINOX), or gemcitabine plus cisplatin (for patients with BRCA1/2 or PALB2 mutations)
Exclusion Criteria:
HEALTHY VOLUNTEERS: Participants having any known major health problems
HEALTHY VOLUNTEERS: Participants with safety contraindications to MRI examination (determined by standard clinical screening)
HEALTHY VOLUNTEERS: Participants on hemodialysis or with acute renal failure
HEALTHY VOLUNTEERS: Participants who are pregnant, lactating or are planning to become pregnant during the study
HEALTHY VOLUNTEERS: Participants who are planning to father a child during the study
PATIENTS: Any history of prior radiation or chemotherapy or surgical removal for pancreatic cancer
PATIENTS: Participants with safety contraindications to MRI examination (determined by standard clinical screening)
PATIENTS: Participants on hemodialysis or with acute renal failure
PATIENTS: Participants who are pregnant, lactating or are planning to become pregnant during the study
PATIENTS: Participants who are planning to farther a child during the study
HEALTHY VOLUNTEERS: No major health problems including but not limited to cancers, heart diseases, diabetes, high blood pressure and/or cholesterol, stroke, respiratory problems, and arthritis
HEALTHY VOLUNTEERS: Participants with signed informed consent
PATIENTS: Patients with newly diagnosed and untreated locally advanced pancreatic cancer
PATIENTS: Patients with signed informed consent
PATIENTS: Patients will be treated with standard-of-care first-line therapeutic regimens including gemcitabine such as nab-paclitaxel, fluorouracil, irinotecan, leucovorin and oxaliplatin (FOLFIRINOX), or gemcitabine plus cisplatin (for patients with BRCA1/2 or PALB2 mutations)
Exclusion Criteria:
HEALTHY VOLUNTEERS: Participants having any known major health problems
HEALTHY VOLUNTEERS: Participants with safety contraindications to MRI examination (determined by standard clinical screening)
HEALTHY VOLUNTEERS: Participants on hemodialysis or with acute renal failure
HEALTHY VOLUNTEERS: Participants who are pregnant, lactating or are planning to become pregnant during the study
HEALTHY VOLUNTEERS: Participants who are planning to father a child during the study
PATIENTS: Any history of prior radiation or chemotherapy or surgical removal for pancreatic cancer
PATIENTS: Participants with safety contraindications to MRI examination (determined by standard clinical screening)
PATIENTS: Participants on hemodialysis or with acute renal failure
PATIENTS: Participants who are pregnant, lactating or are planning to become pregnant during the study
PATIENTS: Participants who are planning to farther a child during the study
