Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-00511 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This pilot clinical trial studies positron emission tomography (PET)-magnetic resonance imaging (MRI) and PET-computed tomography (CT) as diagnostic imaging in patients with colon and/or rectal cancer. New diagnostic imaging procedures, such as PET-MRI, may help find and diagnose rectal cancer or recurrence of colorectal cancer
PRIMARY OBJECTIVES:
I. To test the diagnostic performance of PET- MRI in the staging of preoperative high-grade rectal cancer patients, defined by T3 stage or higher or N1 stage or higher or presence of metastasis, that are referred to PET-CT and MRI.
II. To test the diagnostic performance of PET-MRI the follow up of colorectal cancer patients that are referred to PET-CT with or without a diagnostic MRI request by their physicians.
SECONDARY OBJECTIVES:
I. To test different attenuation correction MR sequences and novel diagnostic MR sequences.
OUTLINE:
Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (PET-CT and PET-MRI) | Experimental | Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| positron emission tomography | Procedure | Undergo fludeoxyglucose F 18 PET-CT and PET-MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Standardized Uptake Value (SUVmax) in Physiologic Regions and Fluorodeoxyglucose (FDG) Avid Lesions in Participants Where PET-CT Was Performed Prior to the PET-MRI | SUV max in physiologic regions (blood pool, liver) and FDG avid lesions, in which the PET-CT was performed prior to the PET-MRI. SUVmax is defined as [tissue concentration (MBq/g) x body weight (g)]/[injected dose (MBq/g)] | Up to 6 months (each scan taking an average of 45 minutes) |
| Maximum Standardized Uptake Value (SUVmax) in Physiologic Regions and FDG Avid Lesions in Participants Where PET-MRI Was Performed Prior to the PET-CT | SUV max in physiologic regions (blood pool, liver) and FDG avid lesions, in which the PET-MRI was performed prior to the PET-CT. SUVmax is defined as [tissue concentration (MBq/g) x body weight (g)]/[injected dose (MBq/g)] | Up to 6 months (each scan taking an average of 45 minutes) |
| SUVmax in Which the PET-CT Was Performed Prior to the PET-MRI. | SUVmax in FDG avid lesions in which the PET/CT was performed prior to the PET-MRI. SUVmax is defined as [tissue concentration (MBq/g) x body weight (g)]/[injected dose (MBq/g)] | Up to 6 months (each scan taking an average of 45 minutes) |
| SUVmax in Which the PET-MRI Was Performed Prior to the PET-CT | SUVmax in FDG avid lesions in which the PET-MRI was performed prior to the PET-CT SUVmax is defined as [tissue concentration (MBq/g) x body weight (g)]/[injected dose (MBq/g)] | Up to 6 months (each scan taking an average of 45 minutes) |
| SUVmax Ratio in Which the PET-CT Was Performed Prior to the PET-MRI | SUVmax ratio in FDG avid lesions in which the PET-CT was performed prior to the PET-MRI SUVmax is defined as [tissue concentration (MBq/g) x body weight (g)]/[injected dose (MBq/g)] |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Raj Paspulati, MD | Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (PET-CT and PET-MRI) | Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI. positron emission tomography: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI computed tomography: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI magnetic resonance imaging: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI fludeoxyglucose F 18: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2013 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| computed tomography | Procedure | Undergo fludeoxyglucose F 18 PET-CT and PET-MRI |
|
|
| magnetic resonance imaging | Procedure | Undergo fludeoxyglucose F 18 PET-CT and PET-MRI |
|
|
| fludeoxyglucose F 18 | Radiation | Undergo fludeoxyglucose F 18 PET-CT and PET-MRI |
|
|
| Up to 6 months (each scan taking an average of 45 minutes) |
| SUVmax Ratio in Which the PET-MRI Was Performed Prior to the PET-CT | SUVmax ratio in FDG avid lesions in which the PET-MRI was performed prior to the PET-CT SUVmax is defined as [tissue concentration (MBq/g) x body weight (g)]/[injected dose (MBq/g)] | Up to 6 months (each scan taking an average of 45 minutes) |
| True Positive Rate | True positive rate for both modalities - TP/TP+FN TP = true positives FN = False negatives | Up to 6 months (each scan taking an average of 45 minutes) |
| True Negative Rate | True negative rate for both modalities - TN/TN+FP TN = true negatives FP = False positives | Up to 6 months (each scan taking an average of 45 minutes) |
| False Negative Rate | False negative rate for both modalities - FN/FN+TP FN = False negatives TP = true positives | Up to 6 months (each scan taking an average of 45 minutes) |
| Proportion of Lesions Identified by PET-CT That Were Correctly Detected by PET-MRI | On a per-lesion basis, proportion of lesions identified by PET-CT that were correctly detected by PET-MRI | Up to 6 months (each scan taking an average of 45 minutes) |
| Positive Predictive Values for PET-CT and PET-MRI | Percent of true positive rate of diagnostic accuracy. | Up to 6 months (each scan taking an average of 45 minutes) |
| Negative Predictive Values for PET-CT and PET-MRI | Percent of true negative rate of diagnostic accuracy | Up to 6 months (each scan taking an average of 45 minutes) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants who were put on study
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (PET-CT and PET-MRI) | Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI. positron emission tomography: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI computed tomography: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI magnetic resonance imaging: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI fludeoxyglucose F 18: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Standardized Uptake Value (SUVmax) in Physiologic Regions and Fluorodeoxyglucose (FDG) Avid Lesions in Participants Where PET-CT Was Performed Prior to the PET-MRI | SUV max in physiologic regions (blood pool, liver) and FDG avid lesions, in which the PET-CT was performed prior to the PET-MRI. SUVmax is defined as [tissue concentration (MBq/g) x body weight (g)]/[injected dose (MBq/g)] | Participants who received PET-CT as initial imaging followed by PET-MRI. Evaluable lesions for this group. | Posted | Median | Full Range | SUV max | Up to 6 months (each scan taking an average of 45 minutes) | Lesions | Lesions |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Maximum Standardized Uptake Value (SUVmax) in Physiologic Regions and FDG Avid Lesions in Participants Where PET-MRI Was Performed Prior to the PET-CT | SUV max in physiologic regions (blood pool, liver) and FDG avid lesions, in which the PET-MRI was performed prior to the PET-CT. SUVmax is defined as [tissue concentration (MBq/g) x body weight (g)]/[injected dose (MBq/g)] | Participants who received PET-MRI was performed prior to the PET-CT. Evaluable lesions for this group. | Posted | Up to 6 months (each scan taking an average of 45 minutes) | Lesions | Lesions |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | SUVmax in Which the PET-CT Was Performed Prior to the PET-MRI. | SUVmax in FDG avid lesions in which the PET/CT was performed prior to the PET-MRI. SUVmax is defined as [tissue concentration (MBq/g) x body weight (g)]/[injected dose (MBq/g)] | Participants who received PET-CT as initial imaging followed by PET-MRI. Evaluable lesions for this group. | Posted | Median | Full Range | SUV max | Up to 6 months (each scan taking an average of 45 minutes) | Lesions | Lesions |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | SUVmax in Which the PET-MRI Was Performed Prior to the PET-CT | SUVmax in FDG avid lesions in which the PET-MRI was performed prior to the PET-CT SUVmax is defined as [tissue concentration (MBq/g) x body weight (g)]/[injected dose (MBq/g)] | Participants who received PET-MRI as initial imaging followed by PET-CT. Evaluable lesions for this group. | Posted | Median | Full Range | SUV max | Up to 6 months (each scan taking an average of 45 minutes) | Lesions | Lesions |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | SUVmax Ratio in Which the PET-CT Was Performed Prior to the PET-MRI | SUVmax ratio in FDG avid lesions in which the PET-CT was performed prior to the PET-MRI SUVmax is defined as [tissue concentration (MBq/g) x body weight (g)]/[injected dose (MBq/g)] | Participants who received PET-CT as initial imaging followed by PET-MRI. Evaluable lesions for this group. | Posted | Median | Full Range | SUV max ratio | Up to 6 months (each scan taking an average of 45 minutes) | Lesions | Lesions |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | SUVmax Ratio in Which the PET-MRI Was Performed Prior to the PET-CT | SUVmax ratio in FDG avid lesions in which the PET-MRI was performed prior to the PET-CT SUVmax is defined as [tissue concentration (MBq/g) x body weight (g)]/[injected dose (MBq/g)] | Participants who received PET-MRI as initial imaging followed by PET-CT. Evaluable lesions for this group. | Posted | Median | Full Range | SUV max | Up to 6 months (each scan taking an average of 45 minutes) | Lesions | Lesions |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | True Positive Rate | True positive rate for both modalities - TP/TP+FN TP = true positives FN = False negatives | Evaluable lesions for this group. | Posted | Number | percentage of true positive results | Up to 6 months (each scan taking an average of 45 minutes) | Lesions | Lesions |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | True Negative Rate | True negative rate for both modalities - TN/TN+FP TN = true negatives FP = False positives | Posted | Number | percent | Up to 6 months (each scan taking an average of 45 minutes) | Lesions | Lesions |
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | False Negative Rate | False negative rate for both modalities - FN/FN+TP FN = False negatives TP = true positives | Evaluable lesions for this group. | Posted | Number | percent | Up to 6 months (each scan taking an average of 45 minutes) | Lesions | Lesions |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Proportion of Lesions Identified by PET-CT That Were Correctly Detected by PET-MRI | On a per-lesion basis, proportion of lesions identified by PET-CT that were correctly detected by PET-MRI | Posted | Number | Lesions | Up to 6 months (each scan taking an average of 45 minutes) | Lesions | Lesions |
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Positive Predictive Values for PET-CT and PET-MRI | Percent of true positive rate of diagnostic accuracy. | Evaluable lesions for this group. | Posted | Number | Percent of true positives | Up to 6 months (each scan taking an average of 45 minutes) | Lesions | Lesions |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Negative Predictive Values for PET-CT and PET-MRI | Percent of true negative rate of diagnostic accuracy | Evaluable lesions for this group. | Posted | Number | Percent of true negatives | Up to 6 months (each scan taking an average of 45 minutes) | Lesions | Lesions |
|
|
Adverse events: At time of intervention, an average of 1 hour Survival: Up to 5 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diagnostic (PET-CT and PET-MRI) | Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI. positron emission tomography: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI computed tomography: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI magnetic resonance imaging: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI fludeoxyglucose F 18: Undergo fludeoxyglucose F 18 PET-CT and PET-MRI | 6 | 15 | 0 | 15 | 0 | 15 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Raj Paspulati | University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | 1-800-641-2422 | Raj.Paspulati@UHhospitals.org |
| Jul 7, 2020 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 16, 2018 | Jul 7, 2020 | ICF_001.pdf |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| C062942 | 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole |
| D019788 | Fluorodeoxyglucose F18 |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
Not provided
Not provided
| 50-59 |
|
| 60-69 |
|
| 70-79 |
|
| 80-89 |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Lesions |
|
|
| Lesions |
|
|
| Lesions |
|
|
| Lesions |
|
|
| Lesions |
|
|
| Lesions |
|
|
| Lesions |
|
|
| Lesions |
|
|
| Lesions |
|
|
| Lesions |
|
|