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Clinical Trial Summary

This is a multi-center study in the United States to evaluate the impact of Cerianna PET/CT results on the clinical management of patients with known or suspected metastatic breast cancer (MBC). By showing whether breast cancer lesions express estrogen receptor (ER), a Cerianna PET/CT scan may guide the physician in choosing the best treatment options for certain patients. Patients who receive either 1st line standard-of-care hormonal therapy or 2nd line standard-of-care hormonal therapy for a primary lesion characterized as ER-positive and human epidermal growth factor receptor 2 (HER2)-negative will be included in the study. Each patient will undergo screening within 30 days before the Cerianna PET/CT scan to determine whether the patient meets all the inclusion criteria and none of the exclusion criteria. After screening, a standardized questionnaire will be completed by the treating physician to evaluate the planned treatment before the Cerianna PET/CT scan. The planned treatment will be evaluated again by the same treating physician within 3 weeks after the Cerianna PET/CT scan using a similar questionnaire. Patients will be followed for 12 months to evaluate the actual treatment undertaken, their clinical status and the results of standard-of-care investigations at 6 months and 12 months after the Cerianna PET/CT scan. Patients will be asked to complete a few questionnaires related to their experience with Cerianna PET/CT. Maximum duration of follow-up for each patient: 14 months. First patient first visit to last patient last visit: Estimated 24 months


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05068726
Study type Observational
Source Zionexa
Contact Jessica Keaney
Phone (978) 243-7447
Email [email protected]
Status Not yet recruiting
Phase
Start date October 31, 2021
Completion date December 31, 2023

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