Clinical trial NCT01892540: PET/CT or PET/MRI in Measuring Tumors in Patients Undergoing Clinical Imaging or With Newly Diagnosed Breast Cancer
Official title: Positron Mammographic Imaging (PMI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-07-04
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

Eligibility criteria: 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

Primary outcomes:
measure: Attenuation Correction for PET/MRI, Assessed Using Standard Uptake Values (SUVs) (Cohorts I & II)
timeFrame: 1 yr from study start
measure: Attenuation Correction for PET/CT, Assessed Using SUVs (Cohorts I & II)
timeFrame: 1 yr from study start
measure: Comparison of Specificity Rates of Fused FDG-PET/MRI (Cohort III)
timeFrame: 1 yr from study start
measure: Sensitivity of PET/CT and PET/MRI (Cohort III)
timeFrame: 1 yr from study start
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Donna Plecha, MD
role: PRINCIPAL_INVESTIGATOR
References: