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

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new, shorter MRI technique to detect liver tumors in patients with colon cancer. The researchers aim to determine if a quicker MRI using the contrast agent Primovist (also known as Gadoxetate) is as effective as the longer standard MRI. Accurate detection of liver metastases (cancer spread) is crucial for surgeons to plan better treatments. Individuals diagnosed with colon cancer and having potentially cancerous liver lesions might be suitable for this trial. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance future diagnostic techniques.

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 prior data suggests that this abbreviated MRI protocol is safe?

Research has shown that Gadoxetate, the dye used in MRI scans to detect liver cancer spread from colon cancer, is generally safe for patients. In a study of 8,194 patients, only 1.7% experienced mild side effects, such as shortness of breath, indicating that most people tolerate it well. Another study confirmed that Gadoxetate is safe even for individuals with varying kidney health, which is crucial for many patients. Overall, evidence suggests that Gadoxetate is a safe choice for enhancing MRI images of the liver in colon cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to use MRI technology for colon cancer with liver metastasis. Unlike the standard full-length MRI protocol, the abbreviated MRI protocol aims to deliver quicker results without compromising accuracy, potentially reducing the time patients spend in the scanner. This could lead to faster diagnosis and treatment planning, making the process more efficient and less burdensome for patients. By using a shortened protocol with Gadoxetate, the trial hopes to maintain high-quality imaging while improving the patient experience and workflow in clinical settings.

What evidence suggests that this MRI protocol is effective for detecting liver metastases from colon cancer?

This trial will compare an abbreviated MRI protocol using Gadoxetate (also known as Primovist) with a full protocol MRI for detecting liver tumors from colon cancer. Research has shown that a shorter MRI scan can effectively find these tumors. Studies have demonstrated that this quicker MRI is as effective as the longer version in detecting tumors. An abbreviated MRI takes less time but still provides reliable results, potentially offering patients a faster and more comfortable experience. Early findings suggest that using this shorter scan could enable more hospitals to offer this important diagnostic tool. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05314400

NCT05314400 | Gadoxetate Abbreviated MRI in Metastatic ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11695540/

Comparative evaluation of non-contrast MRI versus ... The non-enhanced abbreviated MRI (Ab-MRI) protocol is as effective as the gadoxetic acid-enhanced protocol in identifying colorectal liver metastasis (CRLM).

3. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/rycan.2019190006

Abbreviated Gadoxetic Acid–enhanced MRI with Second- ... An abbreviated MRI protocol including SSAP is feasible for liver metastasis evaluation, providing faster image acquisition while preserving diagnostic ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0009926024006214

Clinical performance of a simulated abbreviated liver ... Using a simulated abbreviated liver MRI together with CE-CT showed excellent agreement with standard MRI protocol for liver metastasis detection.

5. ajronline.org ajronline.org/doi/10.2214/AJR.20.22854

Clinical Performance of Abbreviated Liver MRI for the Follow ... Our study shows that the use of an abbreviated liver MRI protocol comprising only HBP gadoxetate disodium–enhanced T1-weighted and DWI ...

6. journals.lww.com journals.lww.com/investigativeradiology/fulltext/9900/clinical_safety_of_gadoxetate_disodium__insights.353.aspx

Clinical Safety of Gadoxetate Disodium Liver-specific gadoxetate disodium demonstrated a favorable safety profile in patients independent of their renal function. No report diagnostic ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7676687/

Abbreviated MRI protocol for colorectal liver metastases The aim of this study was to compare the per-lesion and per-patient detection rate of gadoxetic acid-enhanced liver (Gd-EOB) MRI versus ...

8. insightsimaging.springeropen.com insightsimaging.springeropen.com/articles/10.1186/s13244-024-01886-3

Comparative evaluation of non-contrast MRI versus gadoxetic ... This study compares the diagnostic efficacy of non-contrast abbreviated MRI protocols with Gadoxetic acid-enhanced abbreviated MRI for detecting colorectal ...

9. withpower.com withpower.com/trial/phase-liver-metastasis-colon-cancer-4-2022-5a87e

Abbreviated MRI for Colon Cancer with Liver Metastasis 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 ...