FBnTP Imaging of Breast Cancer
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||FBnTP Positron Emission Mammography Imaging of Mitochondria Function - Breast Cancer|
- Malignant breast cancer detection [ Time Frame: Pre-treatment ] [ Designated as safety issue: No ]A feasibility study to assess the capacity of 18F-FBnTP PEM to detect and localize malignant breast lesions. Histopathology results will serve as reference standard.
- Imaging comparison [ Time Frame: Pre-treatment ] [ Designated as safety issue: No ]To evaluate the concordance in detecting malignant breast lesions between FBnTP PEM and available diagnostic tests such as mammogram, 18F-FDG PEM or MRI.
|Study Start Date:||April 2015|
|Estimated Study Completion Date:||April 2018|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Experimental: Newly diagnosed breast cancer
Patients with newly-diagnosed invasive and/or intraductal breast cancer detected by core needle or vacuum-assisted biopsy (i.e. index cancer). Patients will undergo FBnTP PET imaging for detection of malignant breast cancer.
A PET imaging radiotracer
Other Name: Fluorobenzyl triphenyl phosphonium
Breast cancer is the most widespread type of cancer among women in the USA, and the second leading cause of death. The National Cancer Institute estimates that in 2013, in the USA, 226,870 women will be diagnosed with breast cancer and 39,510 women will die of breast cancer, most of them of progressive metastatic disease. Early detection and treatment of the disease, when the tumor is still localized and at a high curability state, is the outmost important determinant of disease-free survival of breast cancer patients. Survival rate of women first diagnosed with pure early-stage noninvasive tumor (ductal carcinoma in situ- DCIS) is nearly 98%, which drops to 48% in patients with advanced disease.Yet, early detection of breast cancer is relatively poor. This is best exemplify by the astonishing percentage of benign biopsies; 80% of 1.7 million biopsies in the USA, at a cost of $3 billion; whereas, only small fraction (~20%) of newly diagnosed women are found to have pure DCIS.
Our preclinical studies suggest the capacity of the positron emission tomography (PET) imaging agent 18F-fluorobenzyl triphenyl phosphonium (FBnTP) to detects early-stage small breast tumors (e.g., DCIS), and differentiates benign from malignant masses with better accuracy than that obtained by existing breast imaging tools. Accordingly, the present protocol is designed to extend the preclinical findings into clinical studies in breast cancer women, and to assess the effectiveness of 18F-FBnTP in detecting breast malignant lesions, in comparison with magnetic resonance imaging and fluorodeoxyglucose PET imaging.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02204462
|Contact: Akimosa Jeffrey-Kwanisaifirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Igal Madar, PhD 410-614-2789 email@example.com|
|Principal Investigator: Igal Madar, PhD|
|Sub-Investigator: Richard L Wahl, MD|
|Sub-Investigator: Susan Harvey, MD|
|Principal Investigator:||Igal Madar, PhD||Johns Hopkins University|