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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-00938 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| PMI TECH 12-050 | Other Identifier | University Hospitals |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial studies positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) in measuring tumors in patients undergoing clinical imaging or with newly diagnosed breast cancer. New diagnostic procedures, such as PET/CT or PET/MRI, may be more effective than MRI alone in measuring tumors in patients undergoing clinical imaging or with newly diagnosed breast cancer.
PRIMARY OBJECTIVES:
I. To improve visualization of tumors by developing better image reconstruction and correction methods.
II. To revise the positioning devices and, if necessary, scanner table to fit a wider size range of women.
OUTLINE:
Patients undergo clinical fludeoxyglucose F-18 (FDG)-PET/CT followed by prone breast PET/CT and/or prone breast PET/MRI with or without gadopentetate dimeglumine (DTPA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Standard positioning device | Experimental | Patients undergo clinical FDG-PET/CT followed by prone breast PET/CT and/or prone breast PET/MRI with or without DTPA. |
|
| Cohort 2: New positioning device | Experimental |
| |
| Cohort 3: Current positioning device until new is available | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| positron emission tomography/computed tomography | Diagnostic Test | Undergo PET/CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Attenuation Correction for PET/MRI, Assessed Using Standard Uptake Values (SUVs) (Cohorts I & II) | Uptake and attenuation correction of PET/MRI and PET/CT will be examined by comparing SUVs of the two methods. The proportions of subjects with SUV of the PET/MR within 5%, 10%, and 20% of the SUV from PET/CT will be estimated with exact 95% confidence intervals. | 1 yr from study start |
| Attenuation Correction for PET/CT, Assessed Using SUVs (Cohorts I & II) | Uptake and attenuation correction of PET/MRI and PET/CT will be examined by comparing SUVs of the two methods. The proportions of subjects with SUV of the PET/MR within 5%, 10%, and 20% of the SUV from PET/CT will be estimated with exact 95% confidence intervals. | 1 yr from study start |
| Comparison of Specificity Rates of Fused FDG-PET/MRI (Cohort III) | McNemar's test or a generalized estimating equations logistic regression model with patient as the cluster used to compare specificity rates of the new technology versus current technology (MRI alone), restricting analysis to true negative lesions. Utilizing 3 different combinations of scan parameters to determine which combination has the highest specificity. Single parameter: DCE-MRI is the gold standard to which the two parameter and three parameter rows are compared. Combinations include: Single parameter: DCE-MRI Two Parameter A: DCE-MRI and DWI ADC Two Parameter B: DCE-MRI and FDG-PET Three Parameter: DCE-MRI, DWI ADC, FDG-PET | 1 yr from study start |
| Sensitivity of PET/CT and PET/MRI (Cohort III) | McNemar's test or a generalized estimating equations logistic regression model with patient as the cluster used to compare sensitivity rates of the new technology versus current technology (MRI alone), restricting analysis to true negative lesions. Utilizing 3 different combinations of scan parameters to determine which combination has the highest sensitivity. Combinations include: Single parameter: DCE-MRI Two Parameter A: DCE-MRI and DWI ADC Two Parameter B: DCE-MRI and FDG-PET Three Parameter: DCE-MRI, DWI ADC, FDG-PET |
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Inclusion Criteria:
[Cohorts 1 and 2] Female patients who are referred by their physician to have a clinical PET/CT
[Cohort 3] Patients referred for clinical breast dynamic contrast-enhanced (DCE)-MRI for recently diagnosed breast cancer
Normal kidney function for subjects that will receive magnetic resonance (MR) contrast agent as part of their clinical imaging
For subjects for whom MR contrast agent is to be administered, University Hospitals (UH) policy 8.17.26 will be applied
The following guidelines will be followed when a patient or patient representative responds "yes" to questions on the MRI history sheet 'Are you on dialysis, history of kidney failure, end stage renal disease, chronic liver disease, or are you a peri-liver transplant patient':
The patient must have a serum creatinine value available within three (3) weeks prior to the injection of gadolinium
Calculate an estimated glomerular filtration rate (eGFR) based on serum creatinine; if the eGFR is less than 30 the attending radiologist must discuss the risks and benefits of administering gadolinium with the referring physician and patient; the collective judgment of the patient, radiologist and referring physician must be in agreement to proceed with the injection of gadolinium
Calculated eGFR in range of 31-59 requires the judgment of the attending radiologist whether to discuss gadolinium administration with referring physician and patient or whether to directly use or hold the contrast agent
If an eGFR is greater than 60, gadolinium may be administered without further physician or patient discussion
Gadolinium administration is limited to single dose at 0.1mmol/kg; Omniscan should not be used
Technologist will document radiologist decision to administer gadolinium on the MRI history sheet; radiologist will document decision and consultation with the referring physician and patient in the MRI report
PERITONEAL DIALYSIS PATIENTS:
HEMODIALYSIS PATIENTS:
Ability to provide informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donna Plecha, MD | Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Standard Positioning Device | Patients undergo clinical FDG-PET/CT followed by prone breast PET/CT and/or prone breast PET/MRI with or without DTPA. positron emission tomography/computed tomography: Undergo PET/CT PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| PET/MRI | Diagnostic Test | Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging |
|
| Position Device | Device |
|
| 1 yr from study start |
| Cohort 2: New Positioning Device |
positron emission tomography/computed tomography: Undergo PET/CT PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging Position Device |
| FG002 | Cohort 3: Current Positioning Device Until New is Available | positron emission tomography/computed tomography: Undergo PET/CT PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging Position Device |
| COMPLETED |
|
| NOT COMPLETED |
|
|
No participants accrued to cohort 2
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Standard Positioning Device | Patients undergo clinical FDG-PET/CT followed by prone breast PET/CT and/or prone breast PET/MRI with or without DTPA. positron emission tomography/computed tomography: Undergo PET/CT PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging |
| BG001 | Cohort 2: New Positioning Device | positron emission tomography/computed tomography: Undergo PET/CT PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging Position Device |
| BG002 | Cohort 3: Current Positioning Device Until New is Available | positron emission tomography/computed tomography: Undergo PET/CT PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging Position Device |
| BG003 | Total | Total of all reporting groups |
| 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 |
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| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Attenuation Correction for PET/MRI, Assessed Using Standard Uptake Values (SUVs) (Cohorts I & II) | Uptake and attenuation correction of PET/MRI and PET/CT will be examined by comparing SUVs of the two methods. The proportions of subjects with SUV of the PET/MR within 5%, 10%, and 20% of the SUV from PET/CT will be estimated with exact 95% confidence intervals. | No data available - SUV data do not exist for Cohort I and cohort II was never conducted. | Posted | 1 yr from study start |
|
| |||||||||||||||||||||||||
| Primary | Attenuation Correction for PET/CT, Assessed Using SUVs (Cohorts I & II) | Uptake and attenuation correction of PET/MRI and PET/CT will be examined by comparing SUVs of the two methods. The proportions of subjects with SUV of the PET/MR within 5%, 10%, and 20% of the SUV from PET/CT will be estimated with exact 95% confidence intervals. | No data available - SUV data do not exist for Cohort I and cohort II was never conducted. | Posted | 1 yr from study start |
| ||||||||||||||||||||||||||
| Primary | Comparison of Specificity Rates of Fused FDG-PET/MRI (Cohort III) | McNemar's test or a generalized estimating equations logistic regression model with patient as the cluster used to compare specificity rates of the new technology versus current technology (MRI alone), restricting analysis to true negative lesions. Utilizing 3 different combinations of scan parameters to determine which combination has the highest specificity. Single parameter: DCE-MRI is the gold standard to which the two parameter and three parameter rows are compared. Combinations include: Single parameter: DCE-MRI Two Parameter A: DCE-MRI and DWI ADC Two Parameter B: DCE-MRI and FDG-PET Three Parameter: DCE-MRI, DWI ADC, FDG-PET | Participants in cohort 3 that completed scans. | Posted | Mean | Full Range | percent of specificity | 1 yr from study start |
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| Primary | Sensitivity of PET/CT and PET/MRI (Cohort III) | McNemar's test or a generalized estimating equations logistic regression model with patient as the cluster used to compare sensitivity rates of the new technology versus current technology (MRI alone), restricting analysis to true negative lesions. Utilizing 3 different combinations of scan parameters to determine which combination has the highest sensitivity. Combinations include: Single parameter: DCE-MRI Two Parameter A: DCE-MRI and DWI ADC Two Parameter B: DCE-MRI and FDG-PET Three Parameter: DCE-MRI, DWI ADC, FDG-PET | Participants in cohort 3 that completed scans. | Posted | Mean | Full Range | percent sensitivity | 1 yr from study start |
|
Adverse vents and other safety parameters monitored throughout study for up to 1 yr from study start
No participants were enrolled in cohort 2, so no participants are at risk for adverse vents.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Standard Positioning Device | Patients undergo clinical FDG-PET/CT followed by prone breast PET/CT and/or prone breast PET/MRI with or without DTPA. positron emission tomography/computed tomography: Undergo PET/CT PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging | 0 | 15 | 0 | 15 | 0 | 15 |
| EG001 | Cohort 2: New Positioning Device | positron emission tomography/computed tomography: Undergo PET/CT PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging Position Device | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Cohort 3: Current Positioning Device Until New is Available | positron emission tomography/computed tomography: Undergo PET/CT PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging Position Device | 0 | 28 | 0 | 28 | 0 | 28 |
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Cohort 1 was not completed (15 of 40 participants) and cohort 2 was not collected because of recruitment issues.
Imaging data was collected for available participants but SUV data were not collected from images due to low recruitment
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Philipp Frank Graner | University Hospitals | +1 216-844-8275 | philipp.graner@uhhospitals.org |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000072078 | Positron Emission Tomography Computed Tomography |
| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
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| 40-49 years |
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| 50-59 years |
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| 60-69 years |
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| 70-79 years |
|
| Unknown |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
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| OG002 | Cohort 3: Current Positioning Device Until New is Available | positron emission tomography/computed tomography: Undergo PET/CT PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging Position Device |
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positron emission tomography/computed tomography: Undergo PET/CT PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging Position Device |
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