Staging of Axillary Lymph Nodes Using the PEM Flex Solo II Pet Scanner in Patients With Breast Cancer
| Tracking Information | |||||
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| First Received Date ICMJE | November 10, 2009 | ||||
| Last Updated Date | July 27, 2012 | ||||
| Start Date ICMJE | November 2009 | ||||
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The primary objective of the study is to determine the possible role of PEM imaging in assessing ALN involvement preoperatively in patients with newly diagnosed breast cancer, prior to surgical intervention. [ Time Frame: one and a half years ] [ Designated as safety issue: No ] determining the accuracy of FDG positron emission mammography in identifying axillary lymph node metastases from breast cancer |
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| Original Primary Outcome Measures ICMJE |
The primary objective of the study is to determine the possible role of PEM imaging in assessing ALN involvement preoperatively in patients with newly diagnosed breast cancer, prior to surgical intervention. [ Time Frame: one year ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01011946 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Staging of Axillary Lymph Nodes Using the PEM Flex Solo II Pet Scanner in Patients With Breast Cancer | ||||
| Official Title ICMJE | Staging of Axillary Lymph Nodes Using the PEM Flex Solo II Pet Scanner in Patients With Breast Cancer | ||||
| Brief Summary | The purpose of this study is to determine if PEM scan can improve axillary lymph node staging by assessing if they are involved by cancer. Your doctor may refer you for a PEM scan, PEM stands for positron emission mammography, a relatively new and advanced application of positron emission tomography or PET scanning. For decades, PET has helped doctors diagnose and treat disease. |
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| Detailed Description | Subjects will receive bilateral (both sides) breast and axillary PEM scans. All recruited subjects chosen for the study will have biopsy proven breast cancer and are eligible for chemotherapy. They will undergo bilateral breast MRI for staging which is considered standard of care. Breast MRI and PEM scans will be performed at at baseline (phase 0 or pre-operative phase), 2nd MRI and PEM after 1 to 2 weeks of NAC (phase 1) and 3rd MRI and PEM after 1 to 2 weeks of phase 1 (phase 2). DCE-MRI and PEM will be performed not more than 14 days apart within each phase. Cranio-Caudal (CC) and Medial Lateral Oblique (MLO) PEM views will be performed of both the ipsilateral and contralateral breast and axillae by a Mammography Technologist trained in mammographic positioning. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 0 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Breast Cancer | ||||
| Intervention ICMJE | Device: Positron Emission Mammography
Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm). |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 25 | ||||
| Completion Date | May 2012 | ||||
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01011946 | ||||
| Other Study ID Numbers ICMJE | 16893A | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Daniel Appelbaum, University of Chicago | ||||
| Study Sponsor ICMJE | University of Chicago | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Chicago | ||||
| Verification Date | July 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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