Multiparametric Ultrasound for the Imaging of Cancerous and Non-cancerous Tissue in the Pancreas and Thyroid
This clinical trial studies whether two types of ultrasound imaging, multiparametric endoscopic ultrasound (mpEUS) and multiparametric ultrasound (mpUS), can be used for the imaging of cancerous and non-cancerous tissue in the pancreas and thyroid. Standard ultrasound imaging of the pancreas involves an endoscopic ultrasound (EUS), which is a type of ultrasound that uses high-energy sound waves delivered through an endoscope (a thin, tube-like instrument that has a light and a lens for viewing) to look at tissues and organs inside of the body. During standard ultrasound imaging of the thyroid, a probe is passed over the surface of the body to deliver the high-energy sound waves and produce pictures of the tissues and organs inside the body. During mpEUS and mpUS the images are obtained in the same manner as standard ultrasound imaging, but two different ultrasound methods are combined to assess the tissue. This may be a more effective way to examine, evaluate, and provide information about cancerous and non-cancerous tissue in the pancreas and thyroid.
Inclusion Criteria
- PROJECT 1-FEASIBILITY OF mpEUS IMAGING OF PATIENTS AT HIGH-RISK FOR PANCREATIC CANCER: Patient Group: those having standard endoscopic ultrasounds because they are at high risk of pancreatic cancer. Participants enrolled into the Memorial Sloan Kettering Cancer Center Pancreatic Registry protocol (Institutional Review Board [IRB] #: 02-102) will be eligible for this study. Specifically, related individuals without pancreatic cancer who are at-risk for developing pancreatic cancer and meet all of the following criteria (family health history will be self-reported)
- PROJECT 1-FEASIBILITY OF mpEUS IMAGING OF PATIENTS AT HIGH-RISK FOR PANCREATIC CANCER: Patient Group: those having standard endoscopic ultrasounds because they are at high risk of pancreatic cancer: 10 years younger than the earliest pancreatic cancer diagnosis in the family
- PROJECT 1-FEASIBILITY OF mpEUS IMAGING OF PATIENTS AT HIGH-RISK FOR PANCREATIC CANCER: Patient Group: those having standard endoscopic ultrasounds because they are at high risk of pancreatic cancer: Be at least 50 years old
- PROJECT 1-FEASIBILITY OF mpEUS IMAGING OF PATIENTS AT HIGH-RISK FOR PANCREATIC CANCER: Patient Group: those having standard endoscopic ultrasounds because they are at high risk of pancreatic cancer: Be at least 40 years old if diagnosed with Familial Atypical Multiple Mole Melanoma Syndrome (FAMMM) syndrome (CDKN2A/p16) or hereditary pancreatitis (PRSS1, SPINK1/PST1, CTRC, CPA1 or other candidate hereditary pancreatitis genes)
- PROJECT 1-FEASIBILITY OF mpEUS IMAGING OF PATIENTS AT HIGH-RISK FOR PANCREATIC CANCER: Patient Group: those having standard endoscopic ultrasounds because they are at high risk of pancreatic cancer: Be at least 35 years old if diagnosed with Peutz Jeghers syndrome (STK11 aka LKB1)
- PROJECT 1-FEASIBILITY OF mpEUS IMAGING OF PATIENTS AT HIGH-RISK FOR PANCREATIC CANCER: Patient Group: those having standard endoscopic ultrasounds because they are at high risk of pancreatic cancer: Not pregnant and not nursing
- PROJECT 1-FEASIBILITY OF mpEUS IMAGING OF PATIENTS AT HIGH-RISK FOR PANCREATIC CANCER: Patient Group: those having standard endoscopic ultrasounds because they are at high risk of pancreatic cancer: Relatives at least 21 years old with other high-risk clinical criteria that warrants pancreatic cancer surveillance or follow-up as determined by the project leader (Dr. Vineet Rolston)
- PROJECT 1-FEASIBILITY OF mpEUS IMAGING OF PATIENTS AT HIGH-RISK FOR PANCREATIC CANCER: Patient Group: those having standard endoscopic ultrasounds because they are at high risk of pancreatic cancer: Must agree to be contacted for follow-up
- PROJECT 1-FEASIBILITY OF mpEUS IMAGING OF PATIENTS AT HIGH-RISK FOR PANCREATIC CANCER: Patient Group: those having standard endoscopic ultrasounds because they are at high risk of pancreatic cancer: Must satisfy at least one of the following 4 criteria: * Have at least two affected relatives who are a first-degree relative to each other, of whom at least one is a first degree relative to the individual OR have at least two affected first-degree relatives on the same side of the family * Have at least one first- or second-degree affected relative and have germline genetic test results that confirm a likely pathogenic or pathogenic variant in at least one of the following genes: ** Adenomatosis polyposis coli (APC) (Familial Adenomatous Polyposis [FAP] and Attenuated FAP syndrome) ** BRCA1 (Hereditary Breast and Ovarian Cancer Symptoms) ** MLH1, MSH2, MSH6, PMS2, or EPCAM (Lynch Syndrome) ** PALB2 ** TP53 (Li-Fraumeni Syndrome) ** Other established pancreatic cancer predisposition gene per project leader’s discretion * Have germline genetic test results that confirm a likely pathogenic or pathogenic variant in one or more of the following genes: ** CDKN2A/p16 (Familial Atypical Multiple Mole Melanoma Syndrome [FAMMM]) ** STK11 aka LKB1 (Peutz-Jeghers Syndrome) ** PRSS1, SPINK1/PST1, CTRC, CPA1 or other candidate hereditary pancreatitis genes per project leader’s discretion ** ATM (ataxia telangiectasia mutated) ** BRCA 2 (Hereditary Breast and Ovarian Cancer Symptoms) * Relatives at least 21 years old with other high-risk clinical criteria that warrants pancreatic cancer surveillance or follow-up as determined the project leader (Dr. Vineet Rolston)
- PROJECT 2-mpEUS OF PATIENTS WITH PANCREATIC DUCTAL ADENOCARCINOMA: Patient Group: those with pancreatic cancer having endoscopic ultrasound-guided biopsies: Patients with pancreatic ductal adenocarcinoma
- PROJECT 2-mpEUS OF PATIENTS WITH PANCREATIC DUCTAL ADENOCARCINOMA: Patient Group: those with pancreatic cancer having endoscopic ultrasound-guided biopsies: Are undergoing endoscopic ultrasound-guided tissue core biopsy as part of their standard of care
- PROJECT 2-mpEUS OF PATIENTS WITH PANCREATIC DUCTAL ADENOCARCINOMA: Patient Group: those with pancreatic cancer having endoscopic ultrasound-guided biopsies: Not pregnant and not nursing
- PROJECT 3-THYROID NODULE ASSESSMENT WITH mpUS IMAGING: Patient Group: those with a thyroid nodule that will be biopsied whether they have known cancer or not: Are undergoing ultrasound-guided thyroid biopsy as part of their standard of care
- PROJECT 3-THYROID NODULE ASSESSMENT WITH mpUS IMAGING: Patient Group: those with a thyroid nodule that will be biopsied whether they have known cancer or not: Not pregnant and not nursing
- PROJECT 3-THYROID NODULE ASSESSMENT WITH mpUS IMAGING: Healthy Volunteers: No known cancer diagnosis or thyroid nodules
- PROJECT 3-THYROID NODULE ASSESSMENT WITH mpUS IMAGING: Healthy Volunteers: Age ≥ 18
- PROJECT 3-THYROID NODULE ASSESSMENT WITH mpUS IMAGING: Healthy Volunteers: Able to understand and give informed consent
- PROJECT 3-THYROID NODULE ASSESSMENT WITH mpUS IMAGING: Healthy Volunteers: Not pregnant and not nursing
Exclusion Criteria
- PROJECT 2-mpEUS OF PATIENTS WITH PANCREATIC DUCTAL ADENOCARCINOMA: Patient Group: those with pancreatic cancer having endoscopic ultrasound-guided biopsies: Unable to sign an informed consent for medical or other reasons; residents outside the continental United States
- PROJECT 2-mpEUS OF PATIENTS WITH PANCREATIC DUCTAL ADENOCARCINOMA: Patient Group: those with pancreatic cancer having endoscopic ultrasound-guided biopsies: Under 18 years of age
- PROJECT 3-THYROID NODULE ASSESSMENT WITH mpUS IMAGING: Patient Group: those with a thyroid nodule that will be biopsied whether they have known cancer or not: Unable to sign an informed consent for medical or other reasons; residents outside the continental United States
- PROJECT 3-THYROID NODULE ASSESSMENT WITH mpUS IMAGING: Patient Group: those with a thyroid nodule that will be biopsied whether they have known cancer or not: Under 18 years of age
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07270237.
Locations matching your search criteria
United States
New York
New York
PRIMARY OBJECTIVES:
I. To investigate the feasibility of mpEUS imaging for assessment of pancreatic tissue. (Project 1)
II. To investigate the feasibility of mpEUS imaging for assessment of pancreatic cancer. (Project 2)
III. To investigate the feasibility of mpUS imaging for assessment of thyroid nodules. (Project 3)
SECONDARY OBJECTIVES:
I. To evaluate the feasibility of real-time mpEUS. (Project 1)
II. To quantitatively and qualitatively compare mpEUS to standard endoscopic ultrasound (EUS) imaging. (Project 1)
III. To identify associations between mpEUS parameters and histologic findings from biopsy. (Project 2)
IV. To quantitatively and qualitatively compare mpEUS to standard endoscopic ultrasound (EUS) imaging. (Project 2)
V. To identify associations between mpUS parameters and histologic findings from biopsy. (Project 3)
VI. To quantitatively and qualitatively compare mpUS to standard ultrasound imaging. (Project 3)
EXPLORATORY OBJECTIVE:
I. Optimization of mpUS sequence to be 5 minutes of less in healthy volunteers. (Project 3)
OUTLINE: Participants are assigned to 1 of 3 projects.
PROJECTS 1 & 2: Patients undergo mpEUS over 15 minutes during standard of care EUS procedure.
PROJECT 3: Patients undergoing ultrasound-guided biopsy of the thyroid are assigned to group I, healthy volunteers are assigned to group II.
GROUP I: Patients undergo mpUS over 15 minutes during standard of care ultrasound-guided biopsy procedure.
GROUP II: Participants undergo mpUS over 15-30 minutes on study.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorMark T Burgess
- Primary ID25-299
- Secondary IDsNCI-2025-09176
- ClinicalTrials.gov IDNCT07270237