A Study of Multiparametric Ultrasound Imaging Methods

Official title

Development and Evaluation of Ultrasound Imaging Acquisition and Analysis Methods

Overview

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.

Interventions

• Diagnostic test Multiparametric ultrasound (mpUS) imaging
  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.

Primary outcome measures

• investigate the feasibility of mpEUS imaging [Time frame: 1 day]

Eligibility criteria

Inclusion criteria

• Cohort 1 - Feasibility of multiparametric endoscopic ultrasound (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 (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:

• 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)

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:

• Patients with pancreatic ductal adenocarcinoma
• Are undergoing endoscopic ultrasound-guided tissue core biopsy as part of their standard of care
• Not pregnant and not nursing

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

• Are undergoing ultrasound-guided thyroid biopsy as part of their standard of care
• Not pregnant and not nursing

Healthy Volunteers will be entered into the study if they meet the following criteria:

• No known cancer diagnosis or thyroid nodules
• Age ≥ 18
• Able to understand and give informed consent
• Not pregnant and not nursing

Exclusion criteria

Cohort 2 - Multiparametric endoscopic ultrasound imaging (mpEUS) of patients with pancreatic ductal adenocarcinoma:

• Unable to sign an informed consent for medical or other reasons; residents outside the continental United States
• Under 18 years of age

Cohort 3 -Thyroid nodule assessment with multiparametric ultrasound (mpUS) imaging

• Unable to sign an informed consent for medical or other reasons; residents outside the continental United States
• Under 18 years of age

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 7 centers

• Memorial Sloan Kettering Basking Ridge (Consent Only) — Basking Ridge
• Memorial Sloan Kettering Monmouth (Consent Only) — Middletown
• Memorial Sloan Kettering Bergen (Consent Only) — Montvale
• Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack
• Memorial Sloan Kettering Westchester (Consent Only) — Harrison
• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
• Memorial Sloan Kettering Nassau (Consent Only) — Uniondale

Identifiers

NCT: NCT07270237 · 25-299

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗