6D-MRI Predictive Imaging for Pancreatic Cancer

Overseen By Liliana Bancila

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Metastatic cancer, Metallic implants, Claustrophobia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new type of MRI, called Six-Dimensional MRI (6D-MRI), can predict outcomes for people with pancreatic cancer, specifically those with types that might still be surgically removed. Participants will undergo three MRI scans: before, during, and after chemotherapy treatments to assess cancer response. This trial suits patients who haven't received previous treatments for their pancreatic cancer, can undergo at least two MRI scans, and have access to a Fitbit or similar device. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve future cancer treatments.

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

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

What prior data suggests that 6D-MRI is safe for predicting outcomes in pancreatic cancer?

Research has shown that 6D-MRI is a new imaging type that builds on traditional MRI, which is widely used and considered safe. MRI uses magnets and radio waves to create detailed pictures of the body's interior. As an advanced version of this technology, 6D-MRI is expected to be well-tolerated.

MRI is generally non-invasive and does not use radiation, making it safer than some other imaging methods. However, some individuals might feel discomfort, such as warmth during the scan or the need to remain still for extended periods.

Specific safety data for 6D-MRI is not available in the sources, but its use in a study suggests it is considered safe enough for human testing. For concerns, discussing them with the study team is advisable. They can provide more details on what to expect and how they ensure safety during the scans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 6D-MRI predictive imaging for pancreatic cancer because it offers a new way to visualize and predict tumor changes that traditional imaging techniques might miss. Unlike standard imaging methods like CT or regular MRI, which provide static images, 6D-MRI captures dynamic changes over time and space, potentially leading to more personalized and effective treatment plans. This approach could better assess how patients respond to neoadjuvant therapy (NAT), enabling doctors to tailor treatments more precisely and improve outcomes.

What evidence suggests that 6D-MRI is effective for predicting outcomes in pancreatic cancer?

Research has shown that Six-Dimensional Magnetic Resonance Imaging (6D-MRI), which participants in this trial will undergo, can help predict outcomes for patients with pancreatic cancer. One study found that 6D-MRI can distinguish between healthy and cancerous tissue in the pancreas, aiding doctors in assessing cancer progression. Consistently spotting these differences boosts confidence in its predictive ability. This imaging method might also assist doctors in deciding on treatments by revealing how well a patient is responding. ^{1 2 3 4 5}

Who Is on the Research Team?

Stephen Pandol, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for pancreatic cancer patients who can have at least two MRI sessions and are about to start chemotherapy. They must be able to sync a device with Fitbit or use someone else's. It's not for those with severe claustrophobia, previous PDAC treatments, metastatic cancer seen on initial scans, or certain metal implants.

Inclusion Criteria

I have access to a device that can connect to a Fitbit.

I have pancreatic cancer and will receive chemotherapy before surgery.

You are able to have at least two MRI sessions.

Exclusion Criteria

Patients unable to undergo MRI exam w/contrast

My pancreatic cancer has spread and can be seen on scans.

I have been treated for pancreatic cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-NAT Imaging

Participants undergo 6D-MRI imaging before starting neoadjuvant therapy

1 week

1 visit (in-person)

Neoadjuvant Therapy (NAT)

Participants receive neoadjuvant therapy with 6D-MRI imaging during treatment

Varies

1 visit (in-person) for imaging

Post-NAT Imaging

Participants undergo 6D-MRI imaging after completing neoadjuvant therapy

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• 6D-MRI

Trial Overview The study is testing if a new type of MRI called 6D-MRI can predict how well patients with pancreatic ductal adenocarcinoma will respond to treatment before they begin their chemotherapy regimen.

How Is the Trial Designed?

Group I: 6D-MRI Experimental Treatment 1 Intervention

Participants will undergo 6D-MRI imaging three times throughout the course of the study: once pre-NAT treatment, once during NAT treatment, and once post-NAT treatment.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Published Research Related to This Trial

In a study of 167 patients with pancreatic ductal adenocarcinoma, adding hepatic magnetic resonance imaging (MRI) to the standard preoperative evaluation helped identify previously undetected hepatic metastases in 5% of patients without lesions on CT and 32% of those with indeterminate lesions.

Patients who underwent MRI had improved overall survival (24.7 months vs. 18.2 months) and disease-free survival (10.0 months vs. 8.5 months) compared to those who only had CT, suggesting that MRI can help select better surgical candidates and reduce the risk of early recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive role of preoperative liver magnetic resonance imaging for potentially resectable pancreatic cancer. Kim, HW., Lee, JC., Paik, KH., et al.[2022]

Mangafodipir trisodium, a new organ-specific MR contrast agent, enhances MRI's ability to detect small pancreatic tumors and differentiate them from similar lesions, especially in cases where CT results are unclear.

This contrast agent may also improve the staging of pancreatic cancer by increasing MRI's sensitivity in detecting liver metastases, highlighting its potential advantages over traditional CT imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of focal pancreatic masses: comparison of mangafodipir-enhanced MR imaging and contrast-enhanced helical CT. Schima, W., Függer, R.[2020]

In a study of 45 patients with pancreatic cancer, the TRIGIR-DWI technique showed the lowest artifacts and the highest contrast ratio, making it the most effective diffusion-weighted imaging method for this type of cancer at 3.0T.

The TRIGIR-DWI and TRIG-DWI methods provided significantly better contrast-to-noise ratios for detecting pancreatic cancer compared to other techniques, indicating their superior efficacy in differentiating cancerous from noncancerous tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimization of MR diffusion-weighted imaging acquisitions for pancreatic cancer at 3.0T. Yao, X., Kuang, T., Wu, L., et al.[2014]

The study developed a syngeneic murine model of pancreatic cancer that allows for precise monitoring of tumor growth and metastasis using high-resolution 7 Tesla MRI, demonstrating a resolution as low as 0.1 mm.

MRI measurements of tumor volumes were found to be more accurate than traditional calliper measurements, confirming the model's clinical relevance and applicability for future research in pancreatic cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo imaging of pancreatic tumours and liver metastases using 7 Tesla MRI in a murine orthotopic pancreatic cancer model and a liver metastases model. Partecke, IL., Kaeding, A., Sendler, M., et al.[2021]

In a study of 31 pancreatic cancer patients, preoperative MRI staging showed a strong correlation with postoperative pathological staging, indicating that MRI is a reliable tool for evaluating the extent of the disease.

The MRI demonstrated a sensitivity of 100% and a specificity of 67% in predicting the pathology stages of pancreatic cancer, highlighting its clinical significance in assessing resectability before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Value of magnetic resonance images in preoperative staging and resectability assessment of pancreatic cancer. Yang, S., Liu, J., Jin, H., et al.[2022]

Using 3T MR imaging for pancreatic cancer detection shows promise due to improved spatial and temporal resolution, which could enhance early detection and potentially improve survival rates.

Preliminary results indicate that 3T imaging can provide a signal-to-noise ratio up to twice as high as 1.5T, especially after contrast administration, suggesting better image quality for evaluating pancreatic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR imaging of the pancreas: 1.5T versus 3T. Edelman, RR.[2007]

Current prostate cancer detection methods, like PSA screening and TRUS-guided biopsy, have low sensitivity and do not provide comprehensive information about cancer aggressiveness, highlighting the need for improved techniques.

Advanced MRI techniques, such as DCE-MRI and DW-MRI, show promise in enhancing the detection, localization, and characterization of prostate cancer, and future research should adhere to established protocols for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of MRI in prostate cancer detection. Shukla-Dave, A., Hricak, H.[2013]

Magnetic resonance imaging (MRI) is becoming increasingly important for diagnosing prostate cancer due to its high resolution, which allows for effective detection, localization, and evaluation of cancer spread beyond the prostate.

MRI is recommended by clinical guidelines for patients with at least one negative biopsy, and it is particularly useful for staging advanced tumors (cT3/4) or those with a high Gleason score (≥8), enhancing the accuracy of targeted biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prostate cancer]. Franiel, T., Eckardt, N., Waginger, M., et al.[2022]

The 1H MR spectroscopic imaging sequence (1H-2D-CSI) successfully distinguished prostate cancer from benign prostate hyperplasia using the citrate/(choline + creatine) ratio in a study of 18 patients.

However, the method could not differentiate between high-grade prostatic intraepithelial neoplasia and prostate cancer, indicating that higher spatial resolution may be needed for better tumor differentiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Spectroscopic imaging (1H-2D-CSI) of the prostate: sequence optimization and correlation with histopathological results]. Stanka, M., Eltze, E., Semjonow, A., et al.[2013]

A study involving 178 patients showed that 3D-endorectal MRI using the SPACE sequence is highly accurate for local staging of prostate cancer, particularly in detecting extracapsular extension (ECE) and seminal vesicle invasion (SVI).

The combination of direct and indirect MRI signs significantly improved the sensitivity for detecting ECE to 84%, while the sensitivity for SVI detection was 83%, indicating that this imaging technique can help optimize treatment decisions for patients, especially those with low D'Amico risk tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endorectal 3D T2-weighted 1mm-slice thickness MRI for prostate cancer staging at 1.5Tesla: should we reconsider the indirects signs of extracapsular extension according to the D'Amico tumor risk criteria? Cornud, F., Rouanne, M., Beuvon, F., et al.[2022]

MRI is highly effective for assessing pancreatic cancer, particularly in detecting small tumors that do not alter the shape of the pancreas and in evaluating the extent of the disease, including local spread and vascular involvement.

The standard MRI protocol, which includes noncontrast T1-weighted and dynamic gadolinium-enhanced imaging, is crucial for identifying metastases in lymph nodes and the peritoneum, as well as for characterizing liver lesions associated with pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging of adenocarcinoma of the pancreas. Vachiranubhap, B., Kim, YH., Balci, NC., et al.[2022]

In a study of 298 patients with potentially resectable pancreatic ductal adenocarcinoma (PDA), adding contrast-enhanced MRI to standard CT changed the resectability status from resectable to unresectable in 14.4% of cases, indicating its importance in treatment planning.

Patients who underwent both CT and MRI had a significantly longer median time to liver metastasis after curative surgery (9.9 months) compared to those who only had CT (4.2 months), suggesting that MRI may help in better prognostic evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incremental Role of Pancreatic Magnetic Resonance Imaging after Staging Computed Tomography to Evaluate Patients with Pancreatic Ductal Adenocarcinoma. Kim, HJ., Park, MS., Lee, JY., et al.[2022]

A new system for co-registering in-vivo MRI, ex-vivo MRI, and histology in prostate cancer patients was tested on three men, showing a mean co-registration error of only 1.59 mm, indicating high accuracy.

This method enhances the localization of cancer lesions and could improve MRI-guided surgical planning, making it a promising tool for better diagnosis and treatment of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging of prostate cancer: a platform for 3D co-registration of in-vivo MRI ex-vivo MRI and pathology. Orczyk, C., Mikheev, A., Rosenkrantz, AB., et al.[2021]

A comprehensive screening program using 3.0 T MRI for pancreatic cancer was established for 75 high-risk patients, with 56% having hereditary cancer syndromes, highlighting the importance of family history in identifying at-risk individuals.

The screening identified pancreatic cystic lesions in 43% of patients, indicating that MRI can effectively detect potential issues in high-risk groups, although no surgical interventions were performed, suggesting the need for ongoing surveillance rather than immediate surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a high risk pancreatic screening clinic using 3.0 T MRI. Barnes, CA., Krzywda, E., Lahiff, S., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04700488

Magnetic Resonance Imaging (MRI) to Predict Outcomes of ... ... (6D-MRI) is effective in predicting outcomes in patients with pancreatic ductal adenocarcinoma (PDAC). Detailed Description. The overarching goal of this ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7323577/

Six-dimensional quantitative DCE MR Multitasking of the ... Quantitative DCE parameters were repeatable in vivo and showed significant differences between normal pancreas and both tumor and nontumoral regions in patients ...

3. withpower.com withpower.com/trial/phase-adenocarcinoma-7-2021-91bad

6D-MRI Predictive Imaging for Pancreatic Cancer The purpose of this study is to assess if Six-Dimensional Magnetic Resonance Imaging (6D-MRI) is effective in predicting outcomes in patients with pancreatic ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04700488/magnetic-resonance-imaging-mri-to-predict-outcomes-of-pancreatic-ductal-adenocarcinoma-pdac

Magnetic Resonance Imaging (MRI) to Predict Outcomes of ... The purpose of this study is to assess if Six-Dimensional Magnetic Resonance Imaging (6D-MRI) is effective in predicting outcomes in patients ...

5. ancora.ai ancora.ai/en/details/NCT04700488

Magnetic Resonance Imaging (MRI) to Predict Outcomes of ... The purpose of this study is to assess if Six-Dimensional Magnetic Resonance Imaging (6D-MRI) is effective in predicting outcomes in patients with pancreat.