NCT07270237Toboroz
A Study of Multiparametric Ultrasound Imaging Methods
Development and Evaluation of Ultrasound Imaging Acquisition and Analysis Methods
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 12.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 85 (tervezett)
- Első benyújtás
- 2025. nov. 25.
- Kezdés
- 2025. nov. 24.
- Elsődleges befejezés
- 2027. nov.
- Fő szponzor
- Memorial Sloan Kettering Cancer Center
- Betegségek
- Hasnyálmirigyrák
- NCT-szám
- NCT07270237
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 85
- 2025. nov. 24. és az elsődleges befejezés (2027. nov.) között
- 7 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Életkor
- Under 18 years of age
- Cohort 3 -Thyroid nodule assessment with multiparametric ultrasound (mpUS) imaging
- Under 18 years of age
Egyéb
- 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
- Unable to sign an informed consent for medical or other reasons; residents outside the continental United States
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (7)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Consent Only) | Basking Ridge | Egyesült Államok | Toboroz |
| Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) | Commack | Egyesült Államok | Toboroz |
| Memorial Sloan Kettering Westchester (Consent only) | Harrison | Egyesült Államok | Toboroz |
| Memorial Sloan Kettering Monmouth (Consent Only) | Middletown | Egyesült Államok | Toboroz |
| Memorial Sloan Kettering Bergen (Consent Only) | Montvale | Egyesült Államok | Toboroz |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | Egyesült Államok | Toboroz |
| Memorial Sloan Kettering Nassau (Consent Only) | Uniondale | Egyesült Államok | Toboroz |
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