NCT07270237

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable pancreatic-cancer

Timeline
19mo left

Started Nov 2025

Shorter than P25 for not_applicable pancreatic-cancer

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Nov 2025Nov 2027

Study Start

First participant enrolled

November 24, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 25, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 8, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

1.9 years

First QC Date

November 25, 2025

Last Update Submit

December 5, 2025

Conditions

Pancreatic CancerThyroid Nodule

Keywords

UltrasoundmpUS25-299

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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.

Diagnostic Test: Multiparametric ultrasound (mpUS) imaging

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.

Diagnostic Test: Multiparametric ultrasound (mpUS) imaging

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.

Diagnostic Test: Multiparametric ultrasound (mpUS) imaging

Interventions

Multiparametric ultrasound (mpUS) imagingDIAGNOSTIC_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.

Multiparametric endoscopic (mpEUS) imaging of patients at high-risk for pancreatic cancerMultiparametric endoscopic (mpEUS) imaging of patients with pancreatic ductal adenocarcinomaThyroid nodule assessment with multiparametric ultrasound (mpUS) imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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):
  • 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)
  • +25 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Consent Only)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Consent Only)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Consent Only)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Consent Only)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Pancreatic NeoplasmsThyroid Nodule

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesThyroid NeoplasmsHead and Neck NeoplasmsThyroid Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Mark T Burgess, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark T Burgess, PhD

CONTACT

646-608-8284burgesm1@mskcc.org

Wyanne Law, MD

CONTACT

laww@mskcc.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2025

First Posted

December 8, 2025

Study Start

November 24, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

December 12, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

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.

Locations

US(7)