A Study of Multiparametric Ultrasound Imaging Methods

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Thyroid Nodule; Pancreatic Cancer

Treatments: Diagnostic Test: Multiparametric ultrasound (mpUS) imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT07270237

25-299

Details and patient eligibility

About

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.

Enrollment: 85 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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:

  1. 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.

  2. 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:

     1. APC (Familial Adenomatous Polyposis (FAP) and Attenuated FAP syndrome
     2. BRCA1(Hereditary Breast and Ovarian Cancer Symptoms)
     3. MLH1, MSH2, MSH6, PMS2, or EPCAM (Lynch Syndrome)
     4. PALB2
     5. TP53 (Li-Fraumeni Syndrome)
     6. Other established pancreatic cancer predisposition gene per project leader's discretion

  3. Have germline genetic test results that confirm a likely pathogenic or pathogenic variant in one or more of the following genes:

     1. CDKN2A/p16 (Familial Atypical Multiple Mole Melanoma Syndrome (FAMMM))
     2. STK11 aka LKB1 (Peutz-Jeghers Syndrome)
     3. PRSS1, SPINK1/PST1, CTRC, CPA1 or other candidate hereditary pancreatitis genes per project leader's discretion
     4. ATM (ataxia telangiectasia mutated)
     5. BRCA 2(Hereditary Breast and Ovarian Cancer Symptoms)

  4. 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 3 patient groups

Multiparametric endoscopic (mpEUS) imaging of patients at high-risk for pancreatic cancer

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Multiparametric ultrasound (mpUS) imaging

Multiparametric endoscopic (mpEUS) imaging of patients with pancreatic ductal adenocarcinoma

Experimental group

Description:

Subjects will undergo add-on mpEUS imaging during their standard EUS procedure and will add up to approximately 15 minutes of added scan time.

Treatment:

Diagnostic Test: Multiparametric ultrasound (mpUS) imaging

Thyroid nodule assessment with multiparametric ultrasound (mpUS) imaging

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Multiparametric ultrasound (mpUS) imaging