Pancreatic CystNCT06305728
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 of Pancreatic Cyst, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cyst
- What is being tested?
- 89Zr-DFO-HuMab-5B1 immunoPET, HP MRI and Blood assay
- How many people
- 25 participants
- Where
- 8 sitesUnited States
- Study dates
- 4 Mar 2024to 4 Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Men and women aged >18 years
- Pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection
- Able to provide informed consent
Who cannot join
- 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
- Bilirubin > 1.5 x ULN
Show all 11Show fewer
- AST/ALT > 2.5 x ULN
- Albumin < 3 g/dL
- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Kevin Soares, MD, 212-639-3195
- Recruiting
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, 11725
Kevin Soares, MD, 212-639-3195
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Kevin Soares, MD, 212-639-3195
- Recruiting
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748
Kevin Soares, MD, 212-639-3195
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Kevin Soares, MD, 212-639-3195
- Recruiting
Memorial Sloan Kettering Cancer Center (All protocol activites)
New York, New York, 10065
Kevin Soares, MD, 212-639-3195
- Not yet recruiting
Weill Cornell Medical Center (Specimen Analysis Only)
New York, New York, 10065
David Lyden, MD, 212-746-6565
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553
Kevin Soares, PhD, 212-639-3195
About this study
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
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
- Being tested
- 89Zr-DFO-HuMab-5B1 immunoPET, HP MRI, Blood assay
- Keywords
- Pancreatic Cyst, Memorial Sloan Kettering Cancer Center, 23-367
- Medical subject headings
- Pancreatic Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-DFO-HuMab-5B1 immunoPETDiagnostic test
Also called immunoPET
Participants who choose to will undergo immunoPET before surgery.
HP MRIDiagnostic test
Participants who choose to will undergo HP MRI before surgery.
Blood assayCombination product
Also called CA19-.9
Will be drawn within 6 weeks of surgery and annually as post operative care
| Study group | Role | What they receive |
|---|---|---|
| High Risk Pancreatic Cystic Neoplasm | Participants will be diagnosed with a pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection Receives: Diagnostic Test: 89Zr-DFO-HuMab-5B1 immunoPET; Diagnostic Test: HP MRI; Combination Product: Blood assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start4 Mar 2024
- Primary completion4 Mar 2030 (estimated)
- Study completion4 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CystStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Soares, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305728
- Sponsor's protocol ID
- 23-367
- Status last verified
- Aug 2026
- First submitted
- 5 Mar 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06305728
- Acronym / sponsor ID
- 23-367
- Conditions
- Pancreatic Cyst
- Keywords
- Pancreatic Cyst, Memorial Sloan Kettering Cancer Center, 23-367
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 4 Mar 2030 (estimated)
- Study completion
- 4 Mar 2030 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Risk Pancreatic Cystic Neoplasm | – | Diagnostic Test: 89Zr-DFO-HuMab-5B1 immunoPET, Diagnostic Test: HP MRI, Combination Product: Blood assayParticipants will be diagnosed with a pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- Men and women aged >18 years
- Pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection
- Able to provide informed consent
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 89Zr-DFO-HuMab-5B1 immunoPETAlso: immunoPETParticipants who choose to will undergo immunoPET before surgery. | Diagnostic test | High Risk Pancreatic Cystic Neoplasm |
| HP MRIParticipants who choose to will undergo HP MRI before surgery. | Diagnostic test | High Risk Pancreatic Cystic Neoplasm |
| Blood assayAlso: CA19-.9Will be drawn within 6 weeks of surgery and annually as post operative care | Combination product | High Risk Pancreatic Cystic Neoplasm |
Primary outcome
Sensitivity of ImmunoPET to identify presence or absence of adenocarcinoma
Time frame: up to 1 year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
Related trials for Pancreatic Cyst
Not yet recruitingObservational study
AI-Assisted Differentiation of Pancreatic Cystic Lesions Using EUS Images and Clinical Features
Pancreatic Mucinous Cystic Neoplasm, Pancreatic Serous Cystic Neoplasm
RecruitingObservational study
Pancreatic Cancer Early Detection Consortium
Pancreas Cancer, Pancreas Cyst
Recruiting
Determination of Pancreatic Steatosis Prevalence and Correlation With High-risk Cyst Features
Pancreatic Steatosis, Pancreatic Cyst
Recruiting
EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope
Pancreatic Disease, Pancreatic Cancer
RecruitingObservational study
Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
Pancreatic Cyst
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kevin Soares, MD principal investigator
Memorial Sloan Kettering Cancer Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cyst, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin Soares, MD (212-639-3195, soaresk@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of ImmunoPET to identify presence or absence of adenocarcinoma (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.