Investigational Scan for Colorectal Cancer

Overseen By Priya R Bhosale

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must be taking: Chemotherapy

Disqualifiers: Preoperative chemotherapy, Gadolinium allergy, Pacemakers, others

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

Compensation: Varies

Number of Visits: 6

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new scan called intravoxel incoherent motion diffusion weighted imaging (IVIM DWI) to observe how colorectal cancer spreads to the liver and responds to chemotherapy. The goal is to track changes in the cancer before and after treatment using this scan. It involves taking images during a regular MRI session. Individuals with a liver tumor from colorectal cancer who are beginning specific chemotherapy treatments might be suitable for this trial. As an unphased study, this trial offers a unique opportunity to contribute to innovative imaging research that could enhance cancer treatment monitoring.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it seems that participants will start specific chemotherapy treatments, so you should discuss your current medications with the trial team to ensure there are no conflicts.

What prior data suggests that this imaging scan is safe for patients with colorectal liver metastases?

Research has shown that intravoxel incoherent motion diffusion weighted imaging (IVIM DWI) primarily aids in diagnosing and evaluating liver diseases. This non-invasive scan, which doesn't involve surgery or entering the body, generally offers a safer option. Studies have found IVIM DWI effective in assessing the efficacy of certain treatments, particularly for liver conditions.

No specific reports of side effects from the scan itself exist. As a diagnostic tool, patients usually tolerate it well. Most imaging techniques, such as MRI, have a strong safety record, suggesting similar safety for IVIM DWI. Always consult your healthcare provider for detailed information tailored to your situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Intravoxel Incoherent Motion Diffusion Weighted Imaging (IVIM DWI) as a diagnostic technique for colorectal cancer because it provides detailed insights into tumor characteristics without requiring invasive procedures. Unlike traditional imaging methods, IVIM DWI captures both diffusion and perfusion information in a single scan, offering a more comprehensive view of the tumor's microenvironment. This could lead to more precise treatment planning and better monitoring of how well the cancer is responding to chemotherapy, potentially improving patient outcomes.

What evidence suggests that this imaging scan is effective for evaluating colorectal cancer liver metastases?

Research has shown that a special type of imaging called IVIM DWI, which participants in this trial will undergo, can help assess liver tumors in patients with colorectal cancer. This technique examines water movement in cells, aiding in the detection of early tumor changes. IVIM DWI might offer more detailed information than traditional imaging methods, helping doctors evaluate chemotherapy effectiveness. Early evidence suggests that using IVIM DWI could enhance treatment planning and outcomes by accurately tracking tumor response. ^{3 4 6 7 8}

Who Is on the Research Team?

Priya R. Bhosale

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with colorectal cancer that has spread to the liver, who have at least one tumor of 1 cm or larger. They should be starting chemotherapy and able to follow up before and after surgery. It's not for those allergic to gadolinium, previously treated with certain therapies for their liver metastases, having pacemakers, or weighing over 400 pounds.

Inclusion Criteria

I have a liver tumor from colorectal cancer that is at least 1 cm big.

Patients with anticipated follow-up before and after surgery at MD Anderson

I am about to start chemotherapy for liver metastases from colon cancer.

Exclusion Criteria

You have an allergy to gadolinium.

You have a pacemaker implanted.

You weigh more than 400 pounds.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Chemotherapy

Participants receive 4-6 cycles of preoperative chemotherapy

16-24 weeks

Chemotherapy cycles every 4 weeks

Imaging Evaluation

Participants undergo IVIM DWI imaging to evaluate treatment response

Within 30 days of starting chemotherapy and after 4-6 cycles

2 imaging sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intravoxel Incoherent Motion Diffusion Weighted Imaging

Trial Overview The trial is testing a new imaging scan called Intravoxel Incoherent Motion Diffusion Weighted Imaging (IVIM DWI). This scan aims to measure how well colorectal cancer treatments are working in the liver by capturing changes in tumors before and after chemotherapy.

How Is the Trial Designed?

Group I: Diagnostic (IVIM DWI) Experimental Treatment 1 Intervention

Patients undergo IVIM DWI over 10 minutes during standard of care MRI within 30 days of starting chemotherapy and after 4-6 cycles of preoperative chemotherapy.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

In a study of 34 patients with unresectable colorectal cancer liver metastases, IVIM-DWI imaging effectively assessed the early therapeutic response to chemotherapy, showing significant changes in perfusion fraction (f) and true diffusion coefficient (D) values in responders compared to non-responders.

The baseline f value was higher in patients who responded to treatment, indicating its potential as a predictive biomarker for treatment response, with a strong area under the curve (AUC) of 0.797 for predicting outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravoxel incoherent motion diffusion-weighted imaging for early assessment of combined anti-angiogenic/chemotherapy for colorectal cancer liver metastases. Wu, H., Li, B., Yang, Z., et al.[2022]

Using a 0.35-T MRI radiotherapy system to perform diffusion-weighted imaging (DWI) during neoadjuvant chemoradiation (NAC) for rectal cancer is feasible and allows for monitoring treatment responses.

The study found that changes in apparent diffusion coefficients (ADCs) correlated with pathological responses, indicating that higher ADC values may reflect better treatment outcomes, as seen in patients with varying tumor regression scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility evaluation of diffusion-weighted imaging using an integrated MRI-radiotherapy system for response assessment to neoadjuvant therapy in rectal cancer. Shaverdian, N., Yang, Y., Hu, P., et al.[2022]

In a study of 169 oncology patients, single breathhold diffusion-weighted imaging (DWI) during abdominal MRI revealed additional tumors in 77 patients (46%) for one observer and 67 patients (40%) for another, highlighting its effectiveness in detecting malignancies not seen in conventional imaging.

DWI not only identified tumors in patients with normal conventional MR exams but also clarified benign findings, demonstrating its added clinical value in oncology diagnostics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diffusion-weighted MRI (DWI) in the oncology patient: value of breathhold DWI compared to unenhanced and gadolinium-enhanced MRI. Low, RN., Gurney, J.[2019]

In a study of 60 patients, the bi-exponential (BE) model of intravoxel incoherent motion (IVIM) diffusion-weighted imaging (DWI) showed the highest diagnostic performance for predicting rectal adenomas with canceration, with an area under the curve (AUC) of 0.927, indicating strong accuracy.

The apparent diffusion coefficient (ADC) was also effective in predicting rectal adenomas with canceration, demonstrating a high AUC of 0.851, but the combination of multiple parameters from different models (ADC, D, f, and DDC) achieved an even higher AUC of 0.950, with excellent sensitivity (96.6%) and accuracy (88.3%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravoxel incoherent motion DWI with different mathematical models in predicting rectal adenoma with and without canceration. Jia, Y., Song, G., Wu, R., et al.[2022]

The three-dimensional diffusion-prepared stimulated-echo turbo spin-echo sequence (DPsti-TSE) produced less geometrical distortion in rectal cancer imaging compared to traditional diffusion-weighted imaging with echo-planar imaging (DW-EPI), making it a promising technique for accurate tumor assessment.

Despite its advantages in reducing distortion, DPsti-TSE was rated lower in overall image quality and tumor visibility by radiologists compared to DW-EPI, indicating that further improvements are necessary before DPsti-TSE can fully replace DW-EPI in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Locally advanced rectal cancer: 3D diffusion-prepared stimulated-echo turbo spin-echo versus 2D diffusion-weighted echo-planar imaging. Zhang, Q., van Houdt, PJ., Lambregts, DMJ., et al.[2021]

In a study of 33 patients with locally advanced rectal cancer, higher Ktrans values measured after neoadjuvant chemoradiotherapy were associated with a significantly lower probability of disease-free survival (DFS) over four years, indicating that Ktrans can be a useful predictor for distant relapse.

The optimal Ktrans cut-off point for predicting relapse was identified as 28 × 10-3 mL/g/min, with patients below this threshold showing a 93% DFS probability compared to only 45% for those above it, suggesting that patients with higher Ktrans may benefit from more aggressive treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic Contrast-enhanced Magnetic Resonance Imaging Evaluation of Whole Tumour Perfusion Heterogeneity Predicts Distant Disease-free Survival in Locally Advanced Rectal Cancer. Pham, TT., Wong, K., Liney, G., et al.[2022]

Amide proton transfer (APT) and intravoxel incoherent motion (IVIM) imaging provide valuable insights into the prognostic factors of rectal adenocarcinoma, showing significant differences in imaging parameters between histopathological types and tumor grades in a study of 110 patients.

APT signal intensity (APT SI) and diffusion coefficient (D) values were particularly effective in distinguishing between mucinous adenocarcinoma and common adenocarcinoma, with AUCs of 0.921 and 0.893 respectively, indicating their potential utility in clinical evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amide Proton Transfer Weighted and Intravoxel Incoherent Motion Imaging in Evaluation of Prognostic Factors for Rectal Adenocarcinoma. Li, J., Lin, L., Gao, X., et al.[2022]

iShim diffusion weighted imaging (DWI) provides significantly higher image quality compared to single-shot echo-planar imaging (SS-EPI) DWI, as shown in a study of 193 rectal cancer patients, indicating its potential for better diagnostic accuracy.

The iShim-DWI technique also demonstrates the ability to differentiate between well-differentiated and poorly differentiated rectal cancers based on apparent diffusion coefficient (ADC) values, suggesting it could be useful for predicting tumor characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated slice-specific dynamic shimming diffusion weighted imaging (DWI) for rectal Cancer detection and characterization. Qiu, J., Liu, J., Bi, Z., et al.[2021]

Intravoxel incoherent motion diffusion-weighted MRI (DW-MRI) is effective in detecting bowel inflammation in patients with Crohn's disease, as shown in a study involving 16 patients and 79 bowel segments.

The study found that the apparent diffusion coefficient (ADC) and the fraction (f) values were significantly lower in inflamed bowel compared to normal bowel, indicating they are better indicators for distinguishing inflammation than other measured values.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Intravoxel Incoherent Motion Diffusion-Weighted Magnetic Resonance Imaging for Detection of Bowel Inflammation in Patients With Crohn Disease. Yang, HJ., Xi, YL., Guan, XN., et al.[2020]

In a study of 35 rectal cancer patients, diffusion-weighted imaging with background suppression (DWIBS) at 3.0 T MRI effectively differentiated between metastatic and non-metastatic lymph nodes, with significant differences in apparent diffusion coefficient (ADC) values and lymph node diameters.

The optimal cutoff values for ADC and lymph node diameters were established, indicating that while ADC values showed high sensitivity (93.8%), they had lower specificity (30.2%), suggesting that a combination of ADC measurements and size assessments is necessary for accurate diagnosis of lymph node metastasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnosis value of 3.0 T diffusion-weighted imaging with background suppression magnetic resonance for metastatic lymph nodes in rectal cancer]. Zhuang, XZ., Yu, SP., Cui, J., et al.[2011]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9403579/

Intravoxel incoherent motion diffusion-weighted imaging for ... To explore the value of intravoxel incoherent motion diffusion-weighted imaging (IVIM-DWI) in the early assessment of colorectal cancer liver metastases ...

2. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.813138/full

The Value of Intravoxel Incoherent Motion Diffusion ... This study aims to evaluate the value of 3.0T MRI Intravoxel Incoherent motion diffusion-weighted magnetic resonance imaging (IVIM-DWI) combined with texture ...

3. sciencedirect.com sciencedirect.com/org/science/article/pii/S1573405624002832

Intravoxel Incoherent Motion Diffusion-weighted Magnetic ... Statistical Analysis Results of the IVIM-DWI and Texture Parameters in Rectal Cancer Patients. Parameters, Poorly Differentiated Group, Moderately ...

4. insightsimaging.springeropen.com insightsimaging.springeropen.com/articles/10.1186/s13244-025-02075-6

Pretreatment intravoxel incoherent motion histogram metrics ... Wan et al [39] revealed that histogram parameters in zoomed EPI DWI can help predict the PNI status in patients with rectal cancer, which ...

5. nature.com nature.com/articles/s41598-017-09227-9

Intravoxel incoherent motion diffusion-weighted imaging for ... IVIM-DWI may be helpful in identifying the pCR to nCRT for LARC and is more accurate than traditional DWI.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04796818

An Investigational Scan (Intravoxel Incoherent Motion ... IVIM DWI is new kind of imaging scan that may help measure changes in disease before and after chemotherapy in patients with colorectal liver metastases.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7441263/

Progress of intravoxel incoherent motion diffusion ... This study mainly reviews the basic principles of IVIM-DWI and its research progress in the diagnosis and treatment of hepatic diseases.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12183075/

A multivariate model of IVIM-DWI in the preoperative ... The aim of this study was to explore the application value of intravoxel incoherent motion diffusion-weighted imaging (IVIM-DWI) in the preoperative evaluation ...