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

Positron Mammographic Imaging (PMI)

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Unspecified Adult Solid Tumor, Protocol Specific
• Intervention / Treatment: Diagnostic test: positron emission tomography/computed tomography; Diagnostic test: PET/MRI; Device: Position Device

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).

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-5065
      • Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: positron emission tomography/computed tomography; Undergo PET/CT; Diagnostic test: PET/MRI; Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging
Experimental: Cohort 2: New positioning device	Diagnostic test: positron emission tomography/computed tomography; Undergo PET/CT; Diagnostic test: PET/MRI; Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging; Device: Position Device
Experimental: Cohort 3: Current positioning device until new is available	Diagnostic test: positron emission tomography/computed tomography; Undergo PET/CT; Diagnostic test: PET/MRI; Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging; Device: Position Device

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Donna Plecha, MD, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: July 1, 2013
• First Submitted That Met QC Criteria: July 3, 2013
• First Posted (Estimate): July 4, 2013

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CASE15112; NCI-2013-00938 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); PMI TECH 12-050 (Other Identifier: University Hospitals)