NCI Community Oncology Research Program - Kansas City (NCORP-KC)
NCI Community Oncology Research Program - Kansas City (NCORP-KC)




NCI Community Oncology Research Program - Protocol Summary

ECOG-ACRIN EA1151 - "Tomosynthesis Mammographic Imaging Screening Trial (TMIST)"

The summary below serves as a brief review of the treatment plan and eligibility for the protocol.


This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
 

Please contact NCORP-KC for complete protocol information.



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Cancer Control Clinical Trial

CANCER TYPE: Breast
RESEARCH BASE: ECOG-ACRIN
NCT NUMBER: NCT03233191
HIPPA FORM: DOWNLOAD HIPPA FORM

Consent Form: VIEW CONSENT FORM

BRIEF DESCRIPTION

Cancer control, women 45-74, screening mammogram, digital mammography vs. tomosynthesis.  DCP-001 Eligible



NOTES


  • Prior to patient enrollment, all participating scanners must be accredited under the US Mammography Quality Standards Act.

  • All radiologists readers for the study must be qualified to perform TM and DM reads per MQSA guidelines.

  • All original DICOM breast imaging screening exams will be transferred by designated site personnel via TRIAD, and stored at the ACR Imaging Core Laboratory located in Philadelphia, PA.

 

Imaging Schedule

Arm A:  Digital Mammography

T0: within 30 days of randomization
T1: 11-13 months after the T0 scan
T2: 23-25 months after the T0 scan
T3: 35-37 months after the T0 scan
T4: 47-49 months after the T0 scan

Arm B:  Tomosynthesis

T0: within 30 days of randomization
T1: 11-13 months after the T0 scan
T2: 23-25 months after the T0 scan
T3: 35-37 months after the T0 scan
T4: 47-49 months after the T0 scan

 



ELIGIBILITY

  • Patients must be women age 45 or older and under age 75 at the time of study entry.
  • Women of childbearing potential must not be known to be pregnant or lactating.
  • Patients must be scheduled for, or have intent to schedule, a screening mammogram.
  • Patients must be able to tolerate digital breast tomosynthesis and fullfield digital mammographic imaging required by protocol.
  • Patients must be willing and able to provide a written informed consent.
  • Patients must not have symptoms or signs of benign or malignant breast disease (eg, nipple discharge, breast lump) Patients with breast pain are eligible as long as other criteria in 3.1.6 are met.
  • Patients must not have had a screening mammogram within the last 11 months prior to date of randomization.
  • Patients must not have previous personal history of breast cancer including ductal carcinoma in situ.
  • Patients must not currently have breast enhancements (e.g., implants or injections).
  • Annual Screening Regimen Eligibility Check To be eligible for inclusion in the annual screening regimen one of the following three conditions must be met in addition to the eligibility criteria above:
    • Patients are pre-menopausal; OR
    • Post-menopausal aged 45-69 with any of the following three risks factors:
      • Dense Breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense), or
      • Family history of breast cancer (first degree relative with breast cancer), or, positive genetic testing for any deleterious genes that indicate an increased risk for breast cancer, or
      • Currently on hormone therapy; OR
    • Post-menopausal ages 70-74 with either of the following two risk factors:
      • Dense Breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense), or
      • Currently on hormone therapy
    • Postmenopausal women are defined as those with their last menstrual period more than 12 months prior to study entry. For the purpose of defining menopausal status for women who have had surgical cessation of their periods, women who no longer have menses due to hysterectomy and oophorectomy will be considered postmenopausal. Women who no longer have menses due to hysterectomy without oophorectomy will be considered premenopausal until age 52 and postmenopausal thereafter.





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