Weinstein Imaging Associates is one of 16 centers in the U.S. investigating a new breast imaging technology known as Imagio that may potentially improve the accuracy of breast cancer diagnosis and help women with benign masses avoid painful, invasive biopsies.
Imagio combines traditional ultrasound with a new imaging technology based on sound and light called opto-acoustics. The opto-acoustic images provide a unique blood map in and around suspicious breast lesions.
The Imagio Pivotal Study, called the PIONEER Study (Pivotal Study of Imaging with Opto-acoustics to diagnose breast masses detected by mammography and/or clinical findings: a New Evaluation Tool for Radiologists - PIONEER-01) will include approximately 2,000 patients. The study will be conducted over 16 months, 12 of which will be used for patient follow-up.
Women who enroll in the study will undergo a non-invasive, non-ionizing scan with Imagio following a traditional diagnostic breast ultrasound. The Imagio scan will only be used investigationally as a reference to compare the Imagio images to the biopsy results – or to the results of follow up diagnostic imaging scans performed a year later if their mass was not biopsied initially.
Participating centers are currently enrolling women 18 years and older who have masses. Patients may be ineligible if they have had breast implants in the previous 12 months, are pregnant or have had a previous breast biopsy near the suspicious mass in the prior18 months.
The PIONEER study is sponsored by Seno Medical Instruments. For more information on the study, please visit clinicaltrials.gov.
If you or someone you know is interested in joining the study, please call 412.440.6999 or email Chris at email@example.com.
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