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Spots Global Cancer Trial Database for FBnTP Imaging of Breast Cancer

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Trial Identification

Brief Title: FBnTP Imaging of Breast Cancer

Official Title: FBnTP Positron Emission Mammography Imaging of Mitochondria Function - Breast Cancer

Study ID: NCT02204462

Conditions

Breast Cancer

Interventions

FBnTP

Study Description

Brief Summary: Our preclinical studies suggest the capacity of the positron emission tomography 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.

Detailed Description: 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.

Eligibility

Minimum Age: 26 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Johns Hopkins Hospital, Baltimore, Maryland, United States

Contact Details

Name: Martin Pomper, MD

Affiliation: Johns Hopkins University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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