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

Trial Summary

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 data supports the effectiveness of the treatment 6D-MRI for pancreatic cancer?

Research shows that MRI, particularly at higher strengths like 3T, can improve the detection and evaluation of pancreatic cancer by providing clearer images, which helps in assessing the extent of the disease and planning treatment. This suggests that advanced MRI techniques, like 6D-MRI, could potentially enhance the accuracy of pancreatic cancer diagnosis and treatment planning. ^{1 2 3 4 5}

Is 6D-MRI safe for humans?

The research articles do not provide specific safety data for 6D-MRI or its variations in humans, but MRI is generally considered a safe imaging technique. ^{2 6 7 8 9}

How does the 6D-MRI Predictive Imaging treatment for pancreatic cancer differ from other treatments?

The 6D-MRI Predictive Imaging treatment is unique because it uses advanced MRI techniques to potentially predict and assess pancreatic cancer, which may offer more detailed imaging compared to standard methods. This approach could help in better understanding the extent and aggressiveness of the cancer, similar to how advanced MRI techniques are used in prostate cancer detection. ^{10 11 12 13 14}

What is the purpose of this trial?

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 ductal adenocarcinoma (PDAC).

Research Team

Stephen Pandol, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging of adenocarcinoma of the pancreas. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Adjunctive role of preoperative liver magnetic resonance imaging for potentially resectable pancreatic cancer. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. Netherlands pubmed.ncbi.nlm.nih.gov

Optimization of MR diffusion-weighted imaging acquisitions for pancreatic cancer at 3.0T. [2014]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Incremental Role of Pancreatic Magnetic Resonance Imaging after Staging Computed Tomography to Evaluate Patients with Pancreatic Ductal Adenocarcinoma. [2022]

6. England 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. [2021]

7. India pubmed.ncbi.nlm.nih.gov

Value of magnetic resonance images in preoperative staging and resectability assessment of pancreatic cancer. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

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

9. Netherlands pubmed.ncbi.nlm.nih.gov

Development of a high risk pancreatic screening clinic using 3.0 T MRI. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Role of MRI in prostate cancer detection. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Imaging of prostate cancer: a platform for 3D co-registration of in-vivo MRI ex-vivo MRI and pathology. [2021]

12. Germany pubmed.ncbi.nlm.nih.gov

[Prostate cancer]. [2022]

13. Germany pubmed.ncbi.nlm.nih.gov

[Spectroscopic imaging (1H-2D-CSI) of the prostate: sequence optimization and correlation with histopathological results]. [2013]

14. Ireland 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? [2022]