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

NCT ID: NCT01892540

Last Updated: 2020-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-06-30

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).

Conditions

Breast Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

positron emission tomography/computed tomography

Intervention Type: DIAGNOSTIC_TEST

Undergo PET/CT

PET/MRI

Intervention Type: DIAGNOSTIC_TEST

Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging

Cohort 2: New positioning device

Group Type: EXPERIMENTAL

positron emission tomography/computed tomography

Intervention Type: DIAGNOSTIC_TEST

Undergo PET/CT

PET/MRI

Intervention Type: DIAGNOSTIC_TEST

Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging

Position Device

Intervention Type: DEVICE

Cohort 3: Current positioning device until new is available

Group Type: EXPERIMENTAL

positron emission tomography/computed tomography

Intervention Type: DIAGNOSTIC_TEST

Undergo PET/CT

PET/MRI

Intervention Type: DIAGNOSTIC_TEST

Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging

Position Device

Intervention Type: DEVICE

Interventions

positron emission tomography/computed tomography

Undergo PET/CT

Intervention Type: DIAGNOSTIC_TEST

PET/MRI

Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging

Intervention Type: DIAGNOSTIC_TEST

Position Device

Intervention Type: DEVICE

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donna Plecha, MD

Role: PRINCIPAL_INVESTIGATOR

Case Comprehensive Cancer Center

Locations

Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

NCI-2013-00938

Identifier Type: REGISTRY

Identifier Source: secondary_id

PMI TECH 12-050

Identifier Type: OTHER

Identifier Source: secondary_id

CASE15112

Identifier Type: -

Identifier Source: org_study_id