An interventional study of PEM Flex Solo II PET Scanner and MRI scan in Breast Cancer, sponsored by University of Chicago. Terminated at 1 site in United States. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-07-27.
Sponsored by University of Chicago · Not applicable, Interventional, and Treatment
The purpose of this study is:
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 5 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods
Device: PEM Flex Solo II PET Scanner · Device: MRI scan
Subjects will receive bilateral (both sides) breast and axillary PEM scans.
Subjects will receive bilateral (both sides) breast and axillary MRI scans.
Reduction in Tumor Size
Comparison of tumor size pre chemotherapy and post chemotherapy represents the PEM data. There is no the response with MRI because the study was aborted and very few patients were involved.
Time frame: 1-2 weeks post treatment onset
| Milestone | Beast Cancer Subjects |
|---|---|
| Started | 5 |
| Completed | 3 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 2 |
Comparison of tumor size pre chemotherapy and post chemotherapy represents the PEM data. There is no the response with MRI because the study was aborted and very few patients were involved.
| mm | Beast Cancer Subjects |
|---|---|
| PEM tumor size pre chemotherapy | 25.67 ± 7.5 |
| PEM tumor size post chemotherapy | 9.67 ± 16.7 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Beast Cancer Subjects | — | 0/5 (0%) | 0/5 (0%) |
| Age, Continuous(years) | Beast Cancer Subjects |
|---|---|
| Mean | 50.8 ± 6.98 |
| Sex: Female, Male(Participants) | Beast Cancer Subjects |
|---|---|
| Female | 5 |
| Male | 0 |
This study is terminated, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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University of Chicago