Recruiting

ImmunoPET & HP MRI

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06305728

Conditions

Pancreatic Cyst

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

89Zr-DFO-HuMab-5B1 immunoPET

HP MRI

Blood assay

Study Details

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)

Conditions

Pancreatic Cyst

Study ID

NCT06305728

Start date

Mar 4, 2024

Status verified date

Aug, 2026

Completion date

Mar 4, 2030

Anticipated

Primary completion date

Mar 4, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

High Risk Pancreatic Cystic Neoplasm

Participants will be diagnosed with a pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection

Interventions

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.

Blood assay

Will be drawn within 6 weeks of surgery and annually as post operative care

Primary outcome measure

  • Sensitivity of ImmunoPET to identify presence or absence of adenocarcinoma [ Time Frame: up to 1 year ]

Central Contacts and Locations

Central contacts

Kevin Soares, MD

212-639-3195soaresk@mskcc.org

David Kelson, MD

646-888-4179kelsend@MSKCC.ORG

Locations

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Kevin Soares, MD

212-639-3195

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Kevin Soares, MD

212-639-3195

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Kevin Soares, MD

212-639-3195

Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

Recruiting

Commack, New York, United States, 11725

Contacts

Kevin Soares, MD

212-639-3195

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Kevin Soares, MD

212-639-3195

Memorial Sloan Kettering Cancer Center (All protocol activites)

Recruiting

New York, New York, United States, 10065

Contacts

Kevin Soares, MD

212-639-3195

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Kevin Soares, PhD

212-639-3195

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

  • Pancreatic Cyst
  • Memorial Sloan Kettering Cancer Center
  • 23-367

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-08-25.