FBnTP Imaging of Breast Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02204462
First received: July 28, 2014
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: FBnTP
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 30
Study Start Date: August 2014
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: FBnTP
A PET imaging radiotracer
Other Name: Fluorobenzyl triphenyl phosphonium

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

Ages Eligible for Study:   26 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients with newly-diagnosed invasive and/or intraductal breast cancer detected by core needle or vacuum-assisted biopsy (i.e., index cancer)
  • Age > 25 Ability and willingness to sign informed consent prior to any study procedure.
  • Positive indication of disease on mammogram or MRI scan.
  • Candidate for breast cancer surgery on the basis of recommendation of a breast cancer surgeon.
  • Ability to undergo up to 90 minutes of PEM imaging.

Exclusion Criteria:

  • Any active or chronic illness that, in the opinion of the investigators, would make the study unsafe or limit compliance with study procedures.
  • Past or present history of active substance abuse (drug or alcohol).
  • Inability to tolerate venous access.
  • Pregnant females are excluded from this study. All females of child-bearing potential will undergo a serum pregnancy test within 48 hours prior to FBnTP administration.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02204462

Contacts
Contact: John Crandall 4105022186 jcranda1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Igal Madar, PhD    410-614-2789    imadar1@jhmi.edu   
Principal Investigator: Igal Madar, PhD         
Sub-Investigator: Richard L Wahl, MD         
Sub-Investigator: Susan Harvey, MD         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Igal Madar, PhD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02204462     History of Changes
Other Study ID Numbers: J13162, NA_00084913
Study First Received: July 28, 2014
Last Updated: July 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
PET
Positron Emission Tomography
Breast Cancer
Imaging

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014