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

Trial Summary

What is the purpose of this trial?

This trial evaluates the treatment response of colorectal cancer that has spread to the liver (liver metastases) using intravoxel incoherent motion diffusion weighted imaging (IVIM DWI). 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.

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 data supports the effectiveness of the treatment Intravoxel Incoherent Motion Diffusion Weighted Imaging for colorectal cancer?

Research suggests that Intravoxel Incoherent Motion Diffusion Weighted Imaging (IVIM-DWI) can be valuable in assessing colorectal cancer liver metastases and predicting rectal adenomas with canceration, indicating its potential usefulness in evaluating colorectal cancer. ^{1 2 3 4 5}

Is the investigational scan for colorectal cancer safe for humans?

The research articles focus on the use of diffusion-weighted imaging (DWI) techniques, including intravoxel incoherent motion (IVIM), for assessing cancer treatment responses, but they do not provide specific safety data for humans. These imaging techniques are generally considered safe as they are non-invasive and do not involve radiation exposure. ^{1 2 4 6 7}

How is the investigational scan for colorectal cancer different from other treatments?

The investigational scan for colorectal cancer uses a technique called intravoxel incoherent motion diffusion-weighted imaging (IVIM-DWI), which is unique because it helps in early assessment and detection of cancer by analyzing how water molecules move within tissues, potentially offering more detailed insights compared to traditional imaging methods. ^{1 2 8 9 10}

Research Team

Priya R. Bhosale

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Intravoxel incoherent motion diffusion-weighted imaging for early assessment of combined anti-angiogenic/chemotherapy for colorectal cancer liver metastases. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

Intravoxel incoherent motion DWI with different mathematical models in predicting rectal adenoma with and without canceration. [2022]

3. England 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. [2022]

4. England 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. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Amide Proton Transfer Weighted and Intravoxel Incoherent Motion Imaging in Evaluation of Prognostic Factors for Rectal Adenocarcinoma. [2022]

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

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

7. England pubmed.ncbi.nlm.nih.gov

Locally advanced rectal cancer: 3D diffusion-prepared stimulated-echo turbo spin-echo versus 2D diffusion-weighted echo-planar imaging. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Integrated slice-specific dynamic shimming diffusion weighted imaging (DWI) for rectal Cancer detection and characterization. [2021]

9. United States 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. [2020]

10. China 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]. [2011]