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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-07466 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-0004 | Other Identifier | M D Anderson Cancer Center |
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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.
PRIMARY OBJECTIVE:
I. To determine whether intravoxel incoherent motion (IVIM) diffusion weighted imaging (DWI) can detect a difference between the changes in the diffusion related parameters in patients before and after chemotherapy between responders and nonresponders.
SECONDARY OBJECTIVES:
I. Use respiratory-triggered DWI and quantitative T2 maps for the evaluation of colorectal liver metastases (CLM) after treatment.
II. Assess whether changes in these parameters correlate to pathologic treatment response (percent necrosis) determined on pathology.
OUTLINE:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (IVIM DWI) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diffusion Weighted Imaging | Procedure | Undergo IVIM DWI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in the true diffusion coefficient (D) | The absolute changes of parameter D between response and nonresponse groups will be compared using a two-sample t-test. | Up to 3 months or 5 months (each cycle is 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Diffusion related parameters in intravoxel incoherent motion diffusion weighted imaging | Up to 3 months or 5 months (each cycle is 28 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Priya R Bhosale | Contact | 713-792-0221 | priya.bhosale@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Priya R Bhosale | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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