Breast Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DIAGNOSTIC_TESTpositron emission tomography/computed tomography
Undergo PET/CT
DIAGNOSTIC_TESTPET/MRI
Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging
DEVICEPosition Device
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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: * No gadolinium will be administered unless the patient has been scheduled for hemodialysis within 24 hours following the injection of gadolinium; technologist will determine eGFR and follow above guidelines; dialysis will be scheduled by the referring physician * HEMODIALYSIS PATIENTS: * No gadolinium will be administered unless the patient has been scheduled for hemodialysis within 24 hours following the injection of gadolinium; no determination of eGFR is necessary; radiologist will assume eGFR less than 30 and follow above guidelines; dialysis will be scheduled by the referring physician * Ability to provide informed consent
Exclusion criteria
* Subjects who do not meet all of the above inclusion criteria * Subjects unwilling or unable to sign the informed consent form * Subjects who are cognitively impaired and thus unable to give informed consent * Subjects unable to undergo MR scanning due to exclusion via University Hospitals Case Medical Center (UHCMC) MR restrictions (e.g. certain implanted metallic or electronic devices) * Subjects who are pregnant * Subjects that are too large to fit comfortably into the PET/MR on the breast coil; for cohort 1 only we will accept a maximum of 10 subjects that are too large for the PET/MRI to acquire a prone PET/CT but without the paired PET/MR
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attenuation Correction for PET/MRI, Assessed Using Standard Uptake Values (SUVs) (Cohorts I & II) | 1 yr from study start | 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. |
| Attenuation Correction for PET/CT, Assessed Using SUVs (Cohorts I & II) | 1 yr from study start | 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. |
| Comparison of Specificity Rates of Fused FDG-PET/MRI (Cohort III) | 1 yr from study start | 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 |
| Sensitivity of PET/CT and PET/MRI (Cohort III) | 1 yr from study start | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| 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 |
| 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 | 28 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Did not complete PET/MRI | 0 | 0 | 2 |
| Overall Study | Did not fit in scanner | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Cohort 1: Standard Positioning Device | Cohort 2: New Positioning Device | Cohort 3: Current Positioning Device Until New is Available | Total |
|---|---|---|---|---|
| Age, Customized 30-39 years | 3 Participants | 0 Participants | 4 Participants | 7 Participants |
| Age, Customized 40-49 years | 3 Participants | 0 Participants | 5 Participants | 8 Participants |
| Age, Customized 50-59 years | 2 Participants | 0 Participants | 10 Participants | 12 Participants |
| Age, Customized 60-69 years | 4 Participants | 0 Participants | 7 Participants | 11 Participants |
| Age, Customized 70-79 years | 3 Participants | 0 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 0 Participants | 25 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 7 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 12 Participants | 0 Participants | 19 Participants | 31 Participants |
| Region of Enrollment United States | 15 participants | — | 28 participants | 43 participants |
| Sex/Gender, Customized Gender Female | 11 Participants | 0 Participants | 26 Participants | 37 Participants |
| Sex/Gender, Customized Gender Unknown | 4 Participants | 0 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 0 | 0 / 28 |
| other Total, other adverse events | 0 / 15 | 0 / 0 | 0 / 28 |
| serious Total, serious adverse events | 0 / 15 | 0 / 0 | 0 / 28 |
Outcome results
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.
Time frame: 1 yr from study start
Population: No data available - SUV data do not exist for Cohort I and cohort II was never conducted.
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.
Time frame: 1 yr from study start
Population: No data available - SUV data do not exist for Cohort I and cohort II was never conducted.
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
Time frame: 1 yr from study start
Population: Participants in cohort 3 that completed scans.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cohort 3: Current Positioning Device Until New is Available | Comparison of Specificity Rates of Fused FDG-PET/MRI (Cohort III) | Single parameter: DCE-MRI | 0 percent of specificity |
| Cohort 3: Current Positioning Device Until New is Available | Comparison of Specificity Rates of Fused FDG-PET/MRI (Cohort III) | Two Parameter A: DCE-MRI and DWI ADC | 89 percent of specificity |
| Cohort 3: Current Positioning Device Until New is Available | Comparison of Specificity Rates of Fused FDG-PET/MRI (Cohort III) | Two Parameter B: DCE-MRI and FDG-PET | 89 percent of specificity |
| Cohort 3: Current Positioning Device Until New is Available | Comparison of Specificity Rates of Fused FDG-PET/MRI (Cohort III) | Three Parameter: DCE-MRI, DWI ADC, FDG-PET | 100 percent of specificity |
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
Time frame: 1 yr from study start
Population: Participants in cohort 3 that completed scans.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cohort 3: Current Positioning Device Until New is Available | Sensitivity of PET/CT and PET/MRI (Cohort III) | Single parameter: DCE-MRI | 100 percent sensitivity |
| Cohort 3: Current Positioning Device Until New is Available | Sensitivity of PET/CT and PET/MRI (Cohort III) | Two Parameter A: DCE-MRI and DWI ADC | 95 percent sensitivity |
| Cohort 3: Current Positioning Device Until New is Available | Sensitivity of PET/CT and PET/MRI (Cohort III) | Two Parameter B: DCE-MRI and FDG-PET | 86 percent sensitivity |
| Cohort 3: Current Positioning Device Until New is Available | Sensitivity of PET/CT and PET/MRI (Cohort III) | Three Parameter: DCE-MRI, DWI ADC, FDG-PET | 85 percent sensitivity |