ClinicalTrials.gg
RecruitingNCT06305728Updated Aug 25, 2026

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

An observational study in Pancreatic Cyst, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by Memorial Sloan Kettering Cancer Center · Observational

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 54 studies in Pancreatic Cyst with a site in United States — 20 open to participants now, 23 under way, 1 of them phase 3. Pancreatic Cyst · United States.

Planned enrollment
30th of 32
25 · median 300
Started
2024
with 2 others
Observational
32 of 54
12 open now
Primary completion
2030-03
later than 18 of 22 live
Registered
49th of 54
by date
Lead sponsor
2 of 54
Memorial Sloan Kettering Cancer Center

Among the 54 studies in Pancreatic Cyst with a site in United States, this one is the 30th largest by planned enrollment of the 32 observational ones that give a count, is one of 3 that started in 2024, is one of 32 observational ones, reaches primary completion later than 18 of the 22 other live ones, and was the 49th registered.

Pancreatic Cyst

97 studies on the registry are indexed under Pancreatic Cyst; 37 are open to participants now.

Browse Pancreatic Cyst studies →

Open to participants now

20 of the 54 studies in Pancreatic Cyst with a site in United States are open now. Recruiting first, the newest first:

14 more — sign in →

All 20 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 33 Pancreatic Cyst studies recruiting now, 25 (76%) set no upper age limit and 0 (0%) stop at 75 or younger; 2 take children under 18; 7 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 54 studies in Pancreatic Cyst with a site in United States, or all of them as a file.
02

Study 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)
03

Conditions studied

  • Pancreatic Cyst

Browse trials for

Keywords

  • Pancreatic Cyst
  • Memorial Sloan Kettering Cancer Center
  • 23-367
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 (ULN) value for a particular assay will be defined by the normal reference values of the laboratory that performed the assay

    1. > 1.5 x ULN
    2. /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 \< 60 mL/min, from assays obtained within 6 weeks prior to study enrollment
  • Cardiac: congestive heart failure with (NYHA) status ≥2, poorly controlled hypertension, a history of abnormalities, or myocardial infarction within 6 months of study enrollment.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (estimated)
Patient registry
No

Groups and cohorts

  • High Risk Pancreatic Cystic Neoplasm

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

    Diagnostic Test: 89Zr-DFO-HuMab-5B1 immunoPET · Diagnostic Test: HP MRI · Combination Product: Blood assay

Interventions

  • Diagnostic test89Zr-DFO-HuMab-5B1 immunoPET

    Participants who choose to will undergo immunoPET before surgery.

    Also known as: immunoPET

  • Diagnostic testHP MRI

    Participants who choose to will undergo HP MRI before surgery.

  • Combination productBlood assay

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

    Also known as: CA19-.9

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 1 year

07

Study locations

7 of 8 sites recruiting
  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
    Basking Ridge, New Jersey 07920, United States
    Recruiting
    • Kevin Soares, MD · Contact212-639-3195
  • Memorial Sloan Kettering Monmouth (Limited protocol activities)
    Middletown, New Jersey 07748, United States
    Recruiting
    • Kevin Soares, MD · Contact212-639-3195
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
    Montvale, New Jersey 07645, United States
    Recruiting
    • Kevin Soares, MD · Contact212-639-3195
  • Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
    Commack, New York 11725, United States
    Recruiting
    • Kevin Soares, MD · Contact212-639-3195
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
    Harrison, New York 10604, United States
    Recruiting
    • Kevin Soares, MD · Contact212-639-3195
  • Memorial Sloan Kettering Cancer Center (All protocol activites)
    New York, New York 10065, United States
    Recruiting
    • Kevin Soares, MD · Contact212-639-3195
  • Weill Cornell Medical Center (Specimen Analysis Only)
    New York, New York 10065, United States
    Not yet recruiting
    • David Lyden, MD · Contact212-746-6565
  • Memorial Sloan Kettering Nassau (Limited Protocol Activites)
    Rockville Centre, New York 11553, United States
    Recruiting
    • Kevin Soares, PhD · Contact212-639-3195
08

References and documents

Individual participant data

Plan to share: Yes — Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2024 (actual). Primary completion is estimated for Mar 2030, 72 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 5, 2024
First posted
Mar 12, 2024
StartActual
Mar 4, 2024
Primary completionEst.
Mar 4, 2030
CompletionEst.
Mar 4, 2030
Last update
Aug 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06305728
Responsible party
Sponsor
First posted
Mar 12, 2024
Start date
Mar 4, 2024
Primary completion
Mar 4, 2030 (estimated)
Completion
Mar 4, 2030 (estimated)
Last update
Aug 25, 2026

Study contacts

Kevin Soares, MD
Contact
soaresk@mskcc.org
212-639-3195
David Kelson, MD
Contact
kelsend@MSKCC.ORG
646-888-4179
Kevin Soares, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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