Pancreatic CancerNCT07270237
A Study of Multiparametric Ultrasound Imaging Methods
A study testing Multiparametric ultrasound (mpUS) imaging in people with Pancreatic Cancer and Thyroid Nodule, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer, Thyroid Nodule
- What is being tested?
- Multiparametric ultrasound (mpUS) imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 7 sitesUnited States
- Study dates
- 24 Nov 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 40Show fewer
- 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
Who cannot join
- 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 locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Wyanne Law, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920
Mark T Burgess, PhD, 646-608-8284
- Recruiting
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
Mark T Burgess, PhD, 646-608-8284
- Recruiting
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, 10604
Mark T Burgess, PhD, 646-608-8284
- Recruiting
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, 07748
Mark T Burgess, PhD, 646-608-8284
- Recruiting
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645
Mark T Burgess, PhD, 646-608-8284
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Mark T Burgess, PhD, 646-608-8284
Wyanne Law, MD, laww@mskcc.org
- Recruiting
Memorial Sloan Kettering Nassau (Consent Only)
Uniondale, New York, 11553
Mark T Burgess, PhD, 646-608-8284
About this study
Official title: Development and Evaluation of Ultrasound Imaging Acquisition and Analysis Methods
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.
- Conditions
- Pancreatic Cancer, Thyroid Nodule
- Being tested
- Multiparametric ultrasound (mpUS) imaging
- Keywords
- Ultrasound, mpUS, 25-299
- Medical subject headings
- Pancreatic Neoplasms, Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Multiparametric ultrasound (mpUS) imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start24 Nov 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark T Burgess, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270237
- Sponsor's protocol ID
- 25-299
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Ultrasound Imaging Acquisition and Analysis Methods
- ClinicalTrials.gov ID
- NCT07270237
- Acronym / sponsor ID
- 25-299
- Conditions
- Pancreatic Cancer, Thyroid Nodule
- Keywords
- Ultrasound, mpUS, 25-299
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multiparametric endoscopic (mpEUS) imaging of patients at high-risk for pancreatic cancer | Experimental | Diagnostic Test: Multiparametric ultrasound (mpUS) imagingSubjects 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. |
| Multiparametric endoscopic (mpEUS) imaging of patients with pancreatic ductal adenocarcinoma | Experimental | Diagnostic Test: Multiparametric ultrasound (mpUS) imagingSubjects 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 | Diagnostic Test: Multiparametric ultrasound (mpUS) imagingSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (40 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiparametric ultrasound (mpUS) imagingPatients 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. | Diagnostic test | Multiparametric endoscopic (mpEUS) imaging of patients at high-risk for pancreatic cancer, Multiparametric endoscopic (mpEUS) imaging of patients with pancreatic ductal adenocarcinoma, Thyroid nodule assessment with multiparametric ultrasound (mpUS) imaging |
Primary outcome
investigate the feasibility of mpEUS imaging
Time frame: 1 day
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wyanne Law, MD contact
Mark T Burgess, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiparametric ultrasound (mpUS) imaging in people with Pancreatic Cancer and Thyroid Nodule, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 40 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark T Burgess, PhD (646-608-8284, burgesm1@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
investigate the feasibility of mpEUS imaging (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.