A Study of Multiparametric Ultrasound Imaging Methods
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
Unable to sign an informed consent for medical or other reasons; residents outside the continental United States
Under 18 years of age
Unable to sign an informed consent for medical or other reasons; residents outside the continental United States
Under 18 years of age
Trial design
Design model
Parallel
Treatments tested in this trial
Multiparametric ultrasound (mpUS) imaging
Diagnostic testPatients 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.
Treatment groups
85 Participants
are divided into 3 treatment groupsGroup A: Multiparametric endoscopic (mpEUS) imaging of patients at high-risk for pancreatic cancerExperimental treatment 1 intervention
Group B: Multiparametric endoscopic (mpEUS) imaging of patients with pancreatic ductal adenocarcinomaExperimental treatment 1 intervention
Group C: Thyroid nodule assessment with multiparametric ultrasound (mpUS) imagingExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
1 daySponsors and contacts
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Source ClinicalTrials.gov