PET/CT or PET/MRI in Measuring Tumors in Patients Undergoing Clinical Imaging or With Newly Diagnosed Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Positron Mammographic Imaging (PMI)

Conditions
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Breast Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Diagnostic Test: positron emission tomography/computed tomography
* Diagnostic Test: PET/MRI
* Device: Position Device


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Standard positioning device<br>Patients undergo clinical FDG-PET/CT followed by prone breast PET/CT and/or prone breast PET/MRI with or without DTPA. | Diagnostic Test: positron emission tomography/computed tomography<br>* Undergo PET/CT<br>Diagnostic Test: PET/MRI<br>* Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging<br>|
| Experimental: Cohort 2: New positioning device<br> | Diagnostic Test: positron emission tomography/computed tomography<br>* Undergo PET/CT<br>Diagnostic Test: PET/MRI<br>* Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging<br>Device: Position Device<br> <br> |
| Experimental: Cohort 3: Current positioning device until new is available<br> | Diagnostic Test: positron emission tomography/computed tomography<br>* Undergo PET/CT<br>Diagnostic Test: PET/MRI<br>* Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging<br>Device: Position Device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 1 yr from study start |