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Trial record 61 of 95 for:    gadobenate dimeglumine

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

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ClinicalTrials.gov Identifier: NCT01892540
Recruitment Status : Completed
First Posted : July 4, 2013
Last Update Posted : November 9, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Unspecified Adult Solid Tumor, Protocol Specific Procedure: positron emission tomography/computed tomography Radiation: fludeoxyglucose F 18 Device: PET/MRI Radiation: gadopentetate dimeglumine Other: questionnaire administration Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Positron Mammographic Imaging (PMI)
Study Start Date : May 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diagnosis (FDG PET/CT and PET/MRI)
Patients undergo clinical FDG-PET/CT followed by prone breast PET/CT and/or prone breast PET/MRI with or without DTPA.
Procedure: positron emission tomography/computed tomography
Undergo PET/CT

Radiation: fludeoxyglucose F 18
Undergo FDG-PET/CT
Other Names:
  • 18FDG
  • FDG

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

Radiation: gadopentetate dimeglumine
Undergo DTPA-PET/MRI
Other Names:
  • gadolinium DTPA
  • Gd-DTPA
  • Magnevist
  • MultiHance

Other: questionnaire administration
Ancillary studies




Primary Outcome Measures :
  1. Attenuation correction for PET/MRI, assessed using standard uptake values (SUVs) (Cohorts I & II) [ Time Frame: 1 yr from study start ]
    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.

  2. Attenuation correction for PET/CT, assessed using SUVs (Cohorts I & II) [ Time Frame: 1 yr from study start ]
    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.

  3. Specificity rates of fused FDG-PET/MRI (Cohort III) [ Time Frame: 1 yr from study start ]
    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. Positive predictive values (PPVs) calculated from estimates of sensitivity, specificity, and prevalence, and compared between methods using bootstrap confidence intervals for the difference in PPVs. Receiver operating curves (ROCs) also estimated and the areas under the ROC curves compared between methods using methods of Delong et al.

  4. Sensitivity of PET/CT and PET/MRI (Cohort III) [ Time Frame: 1 yr from study start ]
    McNemar's test or a generalized estimating equations logistic regression model with patient as the cluster used to compare sensitivity of methods, restricting analysis to true negative lesions. PPVs calculated from estimates of sensitivity, specificity, and prevalence, and compared between methods using bootstrap confidence intervals for the difference in PPVs. ROCs also estimated and the areas under the ROC curves compared between methods using methods of Delong et al.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892540


Locations
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United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Donna Plecha, MD Case Comprehensive Cancer Center

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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01892540     History of Changes
Other Study ID Numbers: CASE15112
NCI-2013-00938 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PMI TECH 12-050 ( Other Identifier: University Hospitals )
First Posted: July 4, 2013    Key Record Dates
Last Update Posted: November 9, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action