Clinical trial NCT06305728: Hyperpolarized C Pyruvate Magnetic Resonance Imaging, and Blood-Based Biomarkers for Early Detection of Pancreatic Adenocarcinoma in Patients With Intraductal Papillary Mucinous Neoplasms
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Cyst
Keywords: Pancreatic Cyst
Memorial Sloan Kettering Cancer Center
23-367
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan Kettering (MSK).

Brief 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)


Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity of ImmunoPET to identify presence or absence of adenocarcinoma
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited protocol activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All protocol activites)
state: New York
city: New York
country: United States
facility: Weill Cornell Medical Center (Specimen Analysis Only)
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activites)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kevin Soares, MD
role: PRINCIPAL_INVESTIGATOR
References: