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The purpose of this study is to see whether three new types of MRI techniques used during magnetic resonance imaging (MRI) of the pelvis to look at rectal cancer can help doctors to tell if the tumor is getting better in response to the radiation and/or chemotherapy treatments.
This is a pilot study of dynamic contrast enhanced magnetic resonance imaging (DCE-MRI, aka perfusion MRI) and diffusion-weighted MRI (DWI-MRI), herein referred to in combination as advanced MRI (aMRI) in the investigation of early tumor response to standard multi-dose, fractionated external beam radiotherapy (EBRT) of the pelvis given in the neoadjuvant setting concurrent with chemotherapy as well as induction chemotherapy prior to chemoradiotherapy or consolidation chemotherapy after chemoradiotherapy for primary rectal adenocarcinoma. This protocol aims to expand upon the growing body of knowledge concerning early changes in tumor neovascularity and cellular density as a potential biomarker of therapy efficacy. It further aims to address the trend towards more refined treatment stratification for lower risk tumors to avoid morbidity from potentially unnecessary radiation, chemotherapy or even radical surgery, by assessing the earliest changes that occur in microvasculature and perfusion and diffusion of water during this treatment to see if these can be predictive of long-term efficacy of therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 A | Experimental | The patients will undergo the standard pre chemoradiation MRI scan, followed by a repeat research scan 24 hours (+/- 6 hours) after their first radiation treatment. Then they will get another research MRI scan during the second week (+/- 5 days) of radiation. Finally they will get a standard post chemoradiation MRI scan prior to surgery. |
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| 1 B | Experimental | The patient will undergo the standard pre chemoradiation MRI scan, followed by a repeat research scan 48 hours (+/- 6 hours) after their first radiation treatment. Then they will get another research MRI scan during the third week (+/- 5 days) of radiation. Finally they will get a standard post chemoradiation MRI scan prior to surgery. |
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| 1 C | Experimental | The patient will undergo the standard pre chemoradiation MRI scan, followed by a repeat research scan 72 hours (+/- 6 hours) after their first radiation treatment. Then they will get another research MRI scan during the fourth week (+/- 5 days) of radiation. Finally they will get a standard post chemoradiation MRI scan prior to surgery. |
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| 2 | Experimental | The last patient patients that will undergo a standard pre-chemoradiation MRI scan, followed by a repeat research scan either 24, 48 or 72 hours (+/- 6 hours) after their first radiation treatment. Then they will get another research MRI scan during the second, third or fourth week (+/- 5 days) of radiation. Finally they will get a standard post chemoradiation MRI scan prior to surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advanced MR Imaging | Procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| determine the best MR imaging schedule | of early and midterm imaging times using DWI-MRI which will distinguish between near complete (90-99%)/complete pathology and clinical responders and partial/non-responders | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Determine if the best imaging schedule for DCE is the same as for DWI | The analysis plan will be identical to the one for the primary endpoint: six change measures will be computed for each DCE-MRI parameter (parameters Ktrans, Ve, kep, AUC 90, AUC 180) and each of these change measures will be evaluated as a predictor using the reference standard nCR/CR. ROC curves and the area under them will be estimated and used to rank the predictors. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc J. Gollub, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| 3 years |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |