Recruitment

Recruitment Status
Completed
Estimated Enrollment
80

Inclusion Criterias

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
Normal kidney function for subjects that will receive magnetic resonance (MR) contrast agent as part of their clinical imaging
Ability to provide informed consent
...
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
Normal kidney function for subjects that will receive magnetic resonance (MR) contrast agent as part of their clinical imaging
Ability to provide informed consent
[Cohort 3] Patients referred for clinical breast dynamic contrast-enhanced (DCE)-MRI for recently diagnosed breast cancer
The patient must have a serum creatinine value available within three (3) weeks prior to the injection of gadolinium
Gadolinium administration is limited to single dose at 0.1mmol/kg; Omniscan should not be used
If an eGFR is greater than 60, gadolinium may be administered without further physician or patient discussion
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
[Cohorts 1 and 2] Female patients who are referred by their physician to have a clinical PET/CT
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
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
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

Exclusion Criterias

Subjects who do not meet all of the above inclusion criteria
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 unwilling or unable to sign the informed consent form
...
Subjects who do not meet all of the above inclusion criteria
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 unwilling or unable to sign the informed consent form
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
Subjects who are pregnant
Subjects who are cognitively impaired and thus unable to give informed consent

Summary

Conditions
  • Breast Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
Type
Interventional
Design
  • Allocation: Non-Randomized
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Diagnostic

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only females

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 ...

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).

Inclusion Criterias

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
Normal kidney function for subjects that will receive magnetic resonance (MR) contrast agent as part of their clinical imaging
Ability to provide informed consent
...
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
Normal kidney function for subjects that will receive magnetic resonance (MR) contrast agent as part of their clinical imaging
Ability to provide informed consent
[Cohort 3] Patients referred for clinical breast dynamic contrast-enhanced (DCE)-MRI for recently diagnosed breast cancer
The patient must have a serum creatinine value available within three (3) weeks prior to the injection of gadolinium
Gadolinium administration is limited to single dose at 0.1mmol/kg; Omniscan should not be used
If an eGFR is greater than 60, gadolinium may be administered without further physician or patient discussion
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
[Cohorts 1 and 2] Female patients who are referred by their physician to have a clinical PET/CT
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
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
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

Exclusion Criterias

Subjects who do not meet all of the above inclusion criteria
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 unwilling or unable to sign the informed consent form
...
Subjects who do not meet all of the above inclusion criteria
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 unwilling or unable to sign the informed consent form
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
Subjects who are pregnant
Subjects who are cognitively impaired and thus unable to give informed consent

Locations

Cleveland, Ohio, 44106-5065
Cleveland, Ohio, 44106-5065

Tracking Information

NCT #
NCT01892540
Collaborators
National Cancer Institute (NCI)
Investigators
  • Principal Investigator: Donna Plecha, MD Case Comprehensive Cancer Center
  • Donna Plecha, MD Case Comprehensive Cancer Center