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The purpose of this study is to see which participants have a better treatment response using PET/MRI imaging to study the removed tumor, after they have received a total neoadjuvant therapy (TNT). The treatment choice of long course chemo-radiotherapy treatment will be determined by institutional policy.
The researchers will also be looking at whether this study could significantly improve the future management and quality of life of rectal cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | All patients receive total neo-adjuvant therapy (TNT), depending on institutional policy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Neo-adjuvant Therapy | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint of the study is pathological response (pCR) prediction with PET/MRI. | A 3-point scale will be used on PET/MRI assessment. When PET and MRI are concordant, the score remains unchanged. When MRI or PET are discordant, but one modality is definitive for complete response (e.g., MRI showing low intensity crescent at site of tumor or no uptake is identified on corresponding location on PET), a tumor regression grade (TRG) score of 1 will be assigned. | Week 29 - Week 31 |
| Correlation between PET/MRI reported pCR and complete(pCR) or incomplete response(non-pCR) to total neoadjuvant therapy determined by final pathology will be defined. | The pathologic response to the total neo-adjuvant therapy will be assessed generally using classification of tumor regression grade (TRG) defined by Mandard et al. | Week 31 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the significance of PET/MRI compared to MRI to predict response to TNT. | MRI imaging performed before and after TNT and the post TNT scans will be compared to baseline to identify the degree of regression. This comparison to baseline imaging will be performed to avoid misinterpretation of pseudotumor (inflammatory changes within normal rectal wall adjacent to regressed tumor) as residual tumor. |
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Inclusion Criteria:
Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kurian Joseph | Contact | 780-432-8755 | kurian.joseph@ahs.ca |
| Name | Affiliation | Role |
|---|---|---|
| Kurian Joseph | AHS-CCI | Principal Investigator |
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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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|
| 18FDG-PET/MRI scan | Other | 18FDG-PET/MRI scan within 4 weeks of commencing chemo-radiation and within 1 - 2 weeks before radical rectal cancer surgery. |
|
| Week 29 - Week 31 (1 - 2 weeks before surgery) |
| A feasibility study done to evaluate the benefit of using PET/MRI with respect to improved identification of the target and hence target delineation | Therapy plans are generated using image measures derived from standard radiotherapy plans or PET/MRI imaging. CT imaging is the standard imaging procedure used for radiotherapy treatment planning. In this clinical trial, a therapy plan will be generated from the initial PET/MRI imaging performed in the radiotherapy treatment position. This therapy plan will be compared with standard radiotherapy plans to evaluate the significance of using PET/MRI in radiotherapy treatment planning. | Week 29 - Week 31 (1 - 2 weeks before surgery) |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |