A Study of Early Cancer Detection in People at High Risk of Developing Pancreatic Ductal Adenocarcinoma (PDAC)

Pancreatic Cyst Clinical Trial

Official title:

Immuno-Positron Emission Tomography, Hyperpolarized C Pyruvate Magnetic Resonance Imaging, and Blood-Based Biomarkers for Early Detection of Pancreatic Adenocarcinoma in Patients With Intraductal Papillary Mucinous Neoplasms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06305728
• Other study ID #: 23-367
• Status: Recruiting
• Start date: March 4, 2024
• Est. completion date: March 4, 2030

Study information

• Verified date: March 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Kevin Soares, MD
• Phone: 212-639-3195
• Email: soaresk[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is for researchers to find ways of detecting pancreatic ductal adenocarcinoma/PDAC early to avoid the invasive procedure of surgery. The study researchers think a combination of imaging and a series of blood tests may be an effective way to detect PDAC early. In this study, researchers will look at whether a combination of the following types of imaging with blood tests can detect PDAC in pancreatic cysts: - The ImmunoPET scan (immune-positron emission tomography scan) with the imaging agent 89Zr-DFO-HuMab-5B1 - The HP MRI scan (hyperpolarized pyruvate magnetic resonance imaging scan)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 4, 2030
• Est. primary completion date: March 4, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women aged >18 years
• Pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection
• Able to provide informed consent

Exclusion Criteria:

• Pathologic evidence of pancreatic cancer
• Pregnant or breast-feeding patients
• Refusal or inability to tolerate scan (eg anxiety or claustrophobia)
• Inability to lay flat or meet the standard requirements of traditional MRI
• Hepatic function from assays obtained within 6 weeks prior to the study enrollment. For each patient, the upper limit of normal (ULN) value for a particular assay will be defined by the normal reference values of the laboratory that performed the assay

1. Bilirubin > 1.5 x ULN

2. AST/ALT > 2.5 x ULN

3. Albumin < 3 g/dL

4. GGT > 2.5 x ULN if Alkaline Phosphatase > 2.5 x ULN

• Renal function with Creatinine > 1.5 x ULN or creatinine clearance < 60 mL/min, from assays obtained within 6 weeks prior to study enrollment
• Cardiac: congestive heart failure with New York Heart Association (NYHA) status =2, poorly controlled hypertension, a history of clinically significant EKG abnormalities, or myocardial infarction within 6 months of study enrollment.

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Cyst

Intervention

Diagnostic Test:
• 89Zr-DFO-HuMab-5B1 immunoPET
Participants who choose to will undergo immunoPET before surgery.
• HP MRI
Participants who choose to will undergo HP MRI before surgery.

Combination Product:
• Blood assay
Will be drawn within 6 weeks of surgery and annually as post operative care

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Limited Protocol Activities)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Limited protocol activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All protocol activites)	New York	New York
United States	Weill Cornell Medical Center (Specimen Analysis Only)	New York	New York
United States	Memorial Sloan Kettering Nassau (Limited Protocol Activites)	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of ImmunoPET to identify presence or absence of adenocarcinoma	Assess preliminary sensitivity and specificity if the immunoPET is able to identify the presence or absence of adenocarcinoma or high-grade dysplasia in participants who are scheduled to undergo surgical resection.	up to 1 year

External Links

•   Memorial Sloan Kettering Cancer Center