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FBnTP Imaging of Breast Cancer

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
Overall Status
Terminated
CT.gov ID
NCT02204462
Collaborator
(none)
4
Enrollment
1
Location
1
Arm
81.1
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
FBnTP Positron Emission Mammography Imaging of Mitochondria Function - Breast Cancer
Actual Study Start Date :
Mar 12, 2015
Actual Primary Completion Date :
Dec 13, 2021
Actual Study Completion Date :
Dec 13, 2021

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Fluorobenzyl triphenyl phosphonium

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Malignant breast cancer detection [Pre-treatment]

      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

    1. Imaging comparison [Pre-treatment]

      To evaluate the concordance in detecting malignant breast lesions between FBnTP PEM and available diagnostic tests such as mammogram, 18F-FDG PEM or MRI.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    26 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Johns Hopkins Hospital Baltimore Maryland United States 21287

    Sponsors and Collaborators

    • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Investigators

    • Principal Investigator: Martin Pomper, MD, Johns Hopkins University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    ClinicalTrials.gov Identifier:
    NCT02204462
    Other Study ID Numbers:
    • J13162
    • NA_00084913
    First Posted:
    Jul 30, 2014
    Last Update Posted:
    Dec 15, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    PET
    Positron Emission Tomography
    Breast Cancer
    Imaging
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Dec 15, 2021