25 Participants Needed

Imaging and Blood Tests for Early Detection of Pancreatic Cancer

Recruiting at 7 trial locations
DK
KS
Overseen ByKevin Soares, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to catch pancreatic cancer early, focusing on individuals with high-risk pancreatic cysts. Researchers are testing whether a special type of MRI scan, called HP MRI, combined with blood tests, can detect cancer before surgery becomes necessary. Participants diagnosed with a high-risk pancreatic cyst that requires surgical removal might be suitable for this study. The aim is to discover less invasive methods for early cancer detection, potentially avoiding surgery. As a Phase 2 trial, this research measures the effectiveness of these detection methods in an initial, smaller group, offering participants an opportunity to contribute to groundbreaking advancements in early cancer detection.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this combination of imaging and blood tests is safe for detecting PDAC?

Research has shown that the imaging agent 89Zr-DFO-HuMab-5B1 has been tested in patients with pancreatic cancer and similar conditions. Earlier studies found this imaging agent to be generally well-tolerated, with most patients experiencing no serious side effects. However, detailed information about specific side effects remains limited.

The hyperpolarized pyruvate MRI scan is a newer imaging method used to detect changes in cancer cells. Early research indicates it is safe, with no major side effects reported in humans so far.

Both treatments are investigational, meaning they are still under study to ensure safety and effectiveness. Participation in a clinical trial indicates that researchers consider the treatments safe enough for broader testing. However, like any new treatment, there may be risks that are not yet fully understood. By joining the trial, participants contribute to gathering more information about the safety and effectiveness of these treatments.12345

Why are researchers excited about this trial?

Researchers are excited about hyperpolarized C pyruvate magnetic resonance imaging (MRI) for early detection of pancreatic adenocarcinoma because it offers a novel way to spot cancer earlier than current imaging techniques. Unlike traditional methods, which often detect cancer at later stages, this MRI technique uses a special form of pyruvate that enhances the visibility of cancer cells when scanned. This cutting-edge approach could lead to earlier interventions, potentially improving outcomes for patients with high-risk pancreatic cystic neoplasms. Additionally, this method could be combined with blood-based biomarkers to provide a more comprehensive and less invasive diagnostic option.

What evidence suggests that this combination of imaging and blood tests is effective for detecting PDAC early?

Research has shown that a new imaging method using 89Zr-DFO-HuMab-5B1 in ImmunoPET scans could more accurately detect pancreatic tumors. This method targets the CA19-9 marker, often present in pancreatic cancer, enhancing tumor visibility. Participants in this trial, diagnosed with high-risk pancreatic cystic neoplasm, may undergo this imaging method. Additionally, hyperpolarized pyruvate MRI improves the clarity of pancreatic images. Together, these techniques aim to detect pancreatic cancer earlier, potentially helping patients avoid invasive surgery. Early evidence suggests this approach could effectively identify pancreatic cancer in high-risk individuals.678910

Who Is on the Research Team?

KS

Kevin Soares, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

I can understand and agree to the study's procedures and risks.
My pancreatic cyst is high risk and needs surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Blood Tests

Participants undergo ImmunoPET and HP MRI scans along with blood tests to detect pancreatic ductal adenocarcinoma

up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after imaging and blood tests

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • 89Zr-DFO-HuMab-5B1
  • Blood assay
  • HP MRI

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: High Risk Pancreatic Cystic NeoplasmExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Citations

Phase I Assessment of the High-Affinity CA19-9 Antibody ...

In the presented study, pre-injection of 17 and 47 mg unlabeled HuMab-5B1 decreased liver uptake, resulting in improved visualization of liver ...

Hyperpolarized C Pyruvate Magnetic Resonance Imaging, ...

High Risk Pancreatic Cystic Neoplasm, Participants will be diagnosed with a pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection.

Immuno-PET Shows Promise for Detecting and Treating ...

With further validation, 89Zr-DFO-HuMab-5B1 could lead to a host of improvements in pancreatic cancer management--more accurate staging of ...

NCT02672917 | Study of HuMab-5B1 (MVT-5873) in ...

Study Overview. Brief Summary. Phase 1 Safety and Tolerability Study in Subjects with Pancreatic Cancer or Other CA19-9 Positive Malignancies.

Aspects and outcomes of surveillance for individuals at high ...

In this review, we will address the identification of individuals at high risk for PDAC, discuss the objectives and targets of surveillance, outline how ...

Molecular imaging of pancreatic ductal adenocarcinoma

Multimodal imaging and biodistribution data showed that [89Zr]Zr-DFO-ICAM-1-IR800 was mainly uptaken by high CD54-expression tumors but not low ...

Diagnosis of Pancreatic Ductal Adenocarcinoma by ...

Only one study has been conducted with an 89Zr-labeled human mAb in patients with pancreatic cancer or other CA19-9 positive malignancies [125].

Pancreatic Cystic Neoplasms: Diagnosis and Management

IPMNs have a reported 6 to 46% overall risk of transforming into pancreatic cancer, though those coming off of the main pancreatic duct have a higher risk than ...

Pancreatic Cancer (DBCOND0028482)

Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies. Gemcitabine; MVT-5873; Paclitaxel.

Molecular Imaging of Pancreatic Cancer with Antibodies

Among these, 89Zr-5B1 detected orthotopic models of pancreatic ductal adenocarcinoma, an elusive cancer for which the serum assay is measured in humans but ...