Abbreviated MRI for Colon Cancer with Liver Metastasis

Recruiting at 1 trial location

Overseen By Zahra Kassam, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Disqualifiers: MR incompatible devices, Severe claustrophobia, Severe allergic reaction, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

300 Participants Needed

Trial Summary

What is the purpose of this trial?

After a patient is diagnosed with colon cancer, they receive a CT of the chest, abdomen, and pelvis to see if the cancer has spread (metastasized) to other parts of the body. A common site for the cancer to spread to is the liver. If an abnormality is seen in the liver on CT, sometimes an MRI of the liver is required to determine a) whether it is cancer or not and b) whether there are small tumours in the liver that were not visible on CT. During the MRI, the patient is injected with intravenous (IV) contrast. This makes liver lesions more conspicuous and also helps determine if they are cancerous or not. The most commonly used IV contrast agent is called Gadovist. However, there is another IV contrast agent called Primovist that is better at detecting liver metastases from colon cancer than Gadovist. This is very important information for surgeons, because if they considering cutting out (resecting) the liver tumours, they want to make sure they get them all. Unfortunately, Primovist is used sparingly in Canadian hospitals because it is more expensive than Gadovist and the MRI takes longer. Some early small studies have suggested that it may be possible to shorten the Primovist MRI significantly (e.g. from 60 minutes to 15 minutes), making it economically feasible to offer Primovist to more patients. However, there have not been any large studies performed to confirm these findings. The purpose of this study is to compare the accuracy of colon cancer liver metastasis detection between a regular, full-length Primovist MRI versus a shortened Primovist MRI protocol. The economic impact will also be assessed.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Gadoxetate, Primovist, Gadoxetate Disodium, Gadoxetic Acid for colon cancer with liver metastasis?

Research suggests that gadoxetic acid-enhanced MRI is better than CT scans for detecting liver metastases in colorectal cancer, which can help doctors plan more effective treatments. ^{1 2 3 4 5}

Is gadoxetate disodium safe for use in humans?

Gadoxetate disodium, used in liver MRI, is generally safe and well-tolerated, with only 1.7% of 8194 patients experiencing mild side effects like shortness of breath and nausea. No deaths were reported in the studies, indicating a good safety profile. ^{6 7 8 9 10}

How does the abbreviated MRI treatment differ from other treatments for colon cancer with liver metastasis?

The abbreviated MRI treatment for colon cancer with liver metastasis is unique because it uses a shorter MRI protocol with gadoxetic acid, which reduces imaging time while maintaining similar diagnostic performance to standard MRI protocols. This approach can improve the efficiency of follow-up assessments without compromising the accuracy needed for treatment planning. ^{1 3 5 11 12}

Eligibility Criteria

This trial is for adults over 18 with colorectal cancer and liver metastases, who've had a CT scan within the last month. They must be able to undergo MRI and have normal kidney function. It's not for those with widespread liver metastases, severe liver issues, incompatible implants, extreme claustrophobia unaided by medication, exceeding MRI table weight limits or pregnant women.

Inclusion Criteria

Willingness to comply with study procedures and availability for the duration of the study

I have been diagnosed with colorectal cancer through a biopsy.

Able to tolerate MRI required by protocol

Exclusion Criteria

My liver cancer cannot be removed with surgery.

My liver is not working well (ALBI grade 3).

My kidney function is low, with an eGFR below 30.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Participants undergo either an abbreviated or full Primovist MRI between day 2 and 14

2 weeks

1 visit (in-person)

Follow-up Imaging

A follow-up contrast-enhanced CT of the abdomen and pelvis is performed 1 year from baseline

1 year

1 visit (in-person)

Follow-up

Participants are monitored for overall survival, cancer-specific survival, and progression-free survival at 1 year post-baseline

1 year

Treatment Details

Interventions

• Gadoxetate

Trial Overview The study compares two types of MRIs using Primovist contrast: a full-length traditional MRI against a new shortened protocol to see if it can detect colon cancer spread to the liver just as well but faster and cheaper.

Participant Groups

Group I: Abbreviated Protocol Experimental Treatment 1 Intervention

Shortened Primovist MRI

Group II: Full Protocol Active Control 1 Intervention

Routine Primovist MRI

Who Is Running the Clinical Trial?

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Bayer

Industry Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Findings from Research

Gadoxetic acid-enhanced MRI detected significantly more liver metastases compared to contrast-enhanced CT, identifying 220 new lesions in 123 patients, which highlights its superior sensitivity in imaging.

Despite its increased sensitivity in detecting lesions, gadoxetic acid-enhanced MRI did not show a significant impact on overall survival or recurrence-free survival rates compared to contrast-enhanced CT in a study of 480 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between oncological outcomes of patients with colorectal liver metastasis and additional gadoxetic acid-enhanced magnetic resonance imaging. D'Silva, M., Cho, JY., Han, HS., et al.[2021]

In a study of 690 colorectal cancer patients, gadoxetic acid-enhanced liver MRI significantly reduced the number of equivocal hepatic lesions compared to CT, identifying only 4.5% as opposed to 17.2% with CT, indicating its potential for clearer diagnosis.

While the overall clinical efficacy of gadoxetic acid-enhanced liver MRI as a routine preoperative procedure is low, it proved valuable in characterizing uncertain liver lesions and led to changes in surgical plans for 3% of patients, highlighting its role in improving treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is MRI of the Liver Needed During Routine Preoperative Workup for Colorectal Cancer? Kang, SI., Kim, DW., Cho, JY., et al.[2017]

Patients with synchronous liver metastasis of colon cancer who underwent additional MRI alongside CT had a significantly higher 5-year survival rate of 70.8% compared to 48.1% in those assessed with CT alone, indicating the efficacy of MRI in improving patient outcomes.

The use of MRI led to the detection of additional liver metastases that were missed by CT in 39 cases, allowing for more accurate preoperative evaluations and better selection of candidates for curative treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical impact of preoperative liver MRI in the evaluation of synchronous liver metastasis of colon cancer. Kim, C., Kim, SY., Kim, MJ., et al.[2020]

Gadoxetic acid-enhanced liver MRI is significantly more effective than PET/CT in detecting small liver metastases (less than 2 cm), with sensitivities of 95.1% for MRI compared to 59.8% for PET/CT.

The detection of additional metastatic nodules by MRI led to changes in the management plan for 43.8% of patients, highlighting its clinical impact in the preoperative staging of colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the Gadoxetic Acid-Enhanced Liver MRI Impact on the Treatment of Patients with Colorectal Cancer? Comparison Study with ¹⁸F-FDG PET/CT. Oh, JW., Oh, SN., Choi, JI., et al.[2022]

A simulated short MRI protocol for detecting colorectal liver metastases (CRLM) showed a similar detection rate and classification accuracy compared to the standard long protocol, with 86.1% detection for the short protocol and 85.8% for the long protocol among 486 analyzed lesions.

Using the short protocol could reduce the duration of MRI examinations without compromising diagnostic performance, making it a more efficient option for evaluating patients with CRLM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The diagnostic performance of a simulated "short" gadoxetic acid-enhanced MRI protocol is similar to that of a conventional protocol for the detection of colorectal liver metastases. Ghorra, C., Pommier, R., Piveteau, A., et al.[2021]

In a study involving 8194 patients across multiple countries, gadoxetate disodium was found to have a low adverse event rate of 1.7%, indicating it is generally safe for routine use in liver MRI.

The most common adverse events were mild, such as dyspnea and nausea, and importantly, no serious adverse events were related to the drug in the pediatric population, highlighting its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of gadoxetate disodium: results from six clinical phase IV studies in 8194 patients. Endrikat, J., Kim, SY., Sakaguchi, T., et al.[2018]

Gadoxetate disodium, a contrast agent used in MRI, does not induce cytotoxicity or morphological changes in human liver cells at concentrations of 5 and 10 mM, indicating its safety for use in imaging procedures.

The agent significantly alters gene expression in liver cells, enhancing the expression of 29 genes, including a notable 2.62-fold increase in SLCO1C1, which is linked to the uptake of organic anions, suggesting potential effects on liver function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

cDNA Microarray Analysis and Influx Transporter OATP1B1 in Liver Cells After Exposure to Gadoxetate Disodium, a Gadolinium-based Contrast Agent in MRI Liver Imaging. Lu, CC., Chen, WK., Chiang, JH., et al.[2018]

In a study of 211 patients comparing gadoxetic acid and gadoteric acid for liver MRI, gadoxetic acid resulted in significantly poorer image quality during the triple arterial phases, despite better pre-contrast images.

The overall image quality improved from the first to the third arterial phases for both contrast agents, suggesting that the third arterial phase images are the most reliable for diagnostic purposes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of gadoxetic acid on image quality of arterial multiphase magnetic resonance imaging of liver: comparison study with gadoteric acid-enhanced MRI. Sim, KC., Park, BJ., Han, NY., et al.[2020]

In a review of safety data from 12 clinical studies involving 1989 patients, gadoxetate disodium showed a high safety profile, with only 10.1% of patients reporting adverse events, and only 4.1% classified as related to the drug.

The most common related adverse events were nausea and headache, each occurring in 1.1% of patients, and the safety profile remained consistent across various patient subgroups, including those with liver cirrhosis or impaired function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of gadoxetate disodium: Results from the clinical phase II-III development program and postmarketing surveillance. Endrikat, JS., Dohanish, S., Balzer, T., et al.[2022]

Gadoxetate acid (Gd-EOB-DTPA) is a safe and effective liver-specific contrast agent that enhances MRI imaging, improving the detection and characterization of hepatocellular carcinoma (HCC) compared to unenhanced MRI and other imaging methods.

The use of gadoxetate acid allows for better differentiation of early HCC from benign or premalignant nodules, which is crucial for determining appropriate management strategies and improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gadoxetate Acid-Enhanced MR Imaging for HCC: A Review for Clinicians. Chanyaputhipong, J., Low, SC., Chow, PK.[2021]

An abbreviated liver MRI protocol using HBP gadoxetate disodium-enhanced T1-weighted and DWI sequences provides diagnostic results comparable to a standard MRI protocol for assessing colorectal liver metastases in 113 patients, indicating it can effectively evaluate disease presence and treatment response.

The abbreviated protocol significantly reduces imaging time while maintaining high agreement in assessing segmental involvement and treatment response, suggesting it is a practical alternative for post-treatment follow-up without compromising diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Performance of Abbreviated Liver MRI for the Follow-Up of Patients With Colorectal Liver Metastases. Torkzad, MR., Riddell, AM., Chau, I., et al.[2021]

In a study of 83 patients with potentially resectable colorectal liver metastases (CRLM), Gadoxetic acid-enhanced MRI (P-MRI) scans changed treatment plans for 18% of patients and altered the extent of local therapy for another 20%.

P-MRI scans demonstrated a higher accuracy for treatment propositions (93%) compared to conventional CT scans (75%), indicating that P-MRI can significantly improve treatment decision-making and potentially reduce the need for short-term reinterventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gadoxetic acid-enhanced magnetic resonance imaging significantly influences the clinical course in patients with colorectal liver metastases. Sibinga Mulder, BG., Visser, K., Feshtali, S., et al.[2019]

References

1. China pubmed.ncbi.nlm.nih.gov

Association between oncological outcomes of patients with colorectal liver metastasis and additional gadoxetic acid-enhanced magnetic resonance imaging. [2021]

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

Is MRI of the Liver Needed During Routine Preoperative Workup for Colorectal Cancer? [2017]

3. Germany pubmed.ncbi.nlm.nih.gov

Clinical impact of preoperative liver MRI in the evaluation of synchronous liver metastasis of colon cancer. [2020]

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

Does the Gadoxetic Acid-Enhanced Liver MRI Impact on the Treatment of Patients with Colorectal Cancer? Comparison Study with ¹⁸F-FDG PET/CT. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

The diagnostic performance of a simulated "short" gadoxetic acid-enhanced MRI protocol is similar to that of a conventional protocol for the detection of colorectal liver metastases. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Safety of gadoxetate disodium: results from six clinical phase IV studies in 8194 patients. [2018]

7. Greece pubmed.ncbi.nlm.nih.gov

cDNA Microarray Analysis and Influx Transporter OATP1B1 in Liver Cells After Exposure to Gadoxetate Disodium, a Gadolinium-based Contrast Agent in MRI Liver Imaging. [2018]

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

Effects of gadoxetic acid on image quality of arterial multiphase magnetic resonance imaging of liver: comparison study with gadoteric acid-enhanced MRI. [2020]

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

Safety of gadoxetate disodium: Results from the clinical phase II-III development program and postmarketing surveillance. [2022]

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

Gadoxetate Acid-Enhanced MR Imaging for HCC: A Review for Clinicians. [2021]

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

Clinical Performance of Abbreviated Liver MRI for the Follow-Up of Patients With Colorectal Liver Metastases. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Gadoxetic acid-enhanced magnetic resonance imaging significantly influences the clinical course in patients with colorectal liver metastases. [2019]