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

NCT01892540 | Completed Results DMC

• 3 other identifiers: CASE15112NCI-2013-00938PMI TECH 12-050
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Cohort 1: Standard positioning device

EXPERIMENTAL

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; Diagnostic Test: PET/MRI

Cohort 2: New positioning device

EXPERIMENTAL

Diagnostic Test: positron emission tomography/computed tomography; Diagnostic Test: PET/MRI; Device: Position Device

Cohort 3: Current positioning device until new is available

EXPERIMENTAL

Diagnostic Test: positron emission tomography/computed tomography; Diagnostic Test: PET/MRI; Device: Position Device

Interventions

positron emission tomography/computed tomography DIAGNOSTIC_TEST

Undergo PET/CT

Cohort 1: Standard positioning device; Cohort 2: New positioning device; Cohort 3: Current positioning device until new is available

PET/MRI DIAGNOSTIC_TEST

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

Cohort 1: Standard positioning device; Cohort 2: New positioning device; Cohort 3: Current positioning device until new is available

Position Device DEVICE

Cohort 2: New positioning device; Cohort 3: Current positioning device until new is available

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \[Cohorts 1 and 2\] 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

You may not qualify if:

• Subjects unwilling or unable to sign the informed consent form
• Subjects who are cognitively impaired and thus unable to give informed consent
• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Limitations and Caveats

Cohort 1 was not completed (15 of 40 participants) and cohort 2 was not collected because of recruitment issues. Imaging data was collected for available participants but SUV data were not collected from images due to low recruitment

Results Point of Contact

• Title: Philipp Frank Graner
• Organization: University Hospitals

philipp.graner@uhhospitals.org

+1 216-844-8275

Study Officials

• Donna Plecha, MD

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2013
• First Posted: July 4, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 4, 2020
• Results First Posted: February 25, 2020

Record last verified: 2020-02

Locations

US (1)