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The researchers are doing this study to see how well a type of ultrasound imaging called multiparametric ultrasound (mpUS), can be used to examine, evaluate, and provide information about different cancerous and non-cancerous tissue. The researchers will compare the results of mpUS imaging to standard ultrasound imaging and other standard tests.
mpUS imaging is a type of ultrasound imaging that combines different ultrasound methods and analysis to create a more detailed and accurate assessment of tissue. Standard ultrasound provides a basic image of tissue structure, but mpUS imaging can also show blood vessels, blood flow, and detailed tissue structure (microstructure). The researchers think that mpUS may be a better way for evaluating cancer because it combines different ultrasound methods to assess tissue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiparametric endoscopic (mpEUS) imaging of patients at high-risk for pancreatic cancer | Experimental | Subjects will undergo add-on mpEUS imaging during their standard of care EUS imaging and will add up to approximately 15 minutes of added scan time. |
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| Multiparametric endoscopic (mpEUS) imaging of patients with pancreatic ductal adenocarcinoma | Experimental | Subjects will undergo add-on mpEUS imaging during their standard EUS procedure and will add up to approximately 15 minutes of added scan time. |
|
| Thyroid nodule assessment with multiparametric ultrasound (mpUS) imaging | Experimental | Subjects will undergo add-on mpUS imaging at the beginning of their standard of care ultrasound procedure and will add up to approximately 5 minutes of added scan time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiparametric ultrasound (mpUS) imaging | Diagnostic Test | Patients will undergo the added research sequences at any point during their standard of care ultrasound scans, adding up to approximately 15 minutes of added scan time. The only non-routine measurements will be the research ultrasound data. |
| Measure | Description | Time Frame |
|---|---|---|
| investigate the feasibility of mpEUS imaging | the feasibility rate will be estimated and reported using the corresponding sample proportion, along with exact binomial 95% confidence intervals. The mpEUS technique will be considered feasible if it is able to visualize/quantify parameters in at least 21 patients out of the 30 patients. | 1 day |
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Inclusion Criteria:
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 (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):
10 years younger than the earliest pancreatic cancer diagnosis in the family
Be at least 50 years old
Be at least 40 years old if diagnosed with FAMMM syndrome (CDKN2A/p16) or Hereditary Pancreatitis (PRSS1, SPINK1/PST1, CTRC, CPA1 or other candidate hereditary pancreatitis genes)
Be at least 35 years old if diagnosed with Peutz-Jeghers syndrome (STK11 aka LKB1)
Not pregnant and not Nursing
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)
Must agree to be contacted for follow-up
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:
Have germline genetic test results that confirm a likely pathogenic or pathogenic variant in one or more of the following genes:
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)
Cohort 2 - Multiparametric endoscopic ultrasound imaging (mpEUS) of patients with pancreatic ductal adenocarcinoma:
Patient Group: those with pancreatic cancer having endoscopic ultrasound-guided biopsies
Patients will be entered into the study if they meet the following criteria:
Cohort 3 - Thyroid nodule assessment with multiparametric ultrasound (mpUS) imaging:
Patient Group: those with a thyroid nodule that will be biopsied whether they have known cancer or not
Healthy Volunteers will be entered into the study if they meet the following criteria:
Exclusion Criteria:
Cohort 2 - Multiparametric endoscopic ultrasound imaging (mpEUS) of patients with pancreatic ductal adenocarcinoma:
Cohort 3 -Thyroid nodule assessment with multiparametric ultrasound (mpUS) imaging
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark T Burgess, PhD | Contact | 646-608-8284 | burgesm1@mskcc.org | |
| Wyanne Law, MD | Contact | laww@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Mark T Burgess, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Consent Only) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D016606 | Thyroid Nodule |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| Memorial Sloan Kettering Monmouth (Consent Only) | Recruiting | Middletown | New Jersey | 07748 | United States |
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| Memorial Sloan Kettering Bergen (Consent Only) | Recruiting | Montvale | New Jersey | 07645 | United States |
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| Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) | Recruiting | Commack | New York | 11725 | United States |
|
| Memorial Sloan Kettering Westchester (Consent Only) | Recruiting | Harrison | New York | 10604 | United States |
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| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Recruiting | New York | New York | 10065 | United States |
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| Memorial Sloan Kettering Nassau (Consent Only) | Recruiting | Uniondale | New York | 11553 | United States |
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D013964 | Thyroid Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D013959 | Thyroid Diseases |