FBnTP Imaging of Breast Cancer

NCT02204462 | Terminated Phase 1

• 2 other identifiers: J13162NA_00084913
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

PET; Positron Emission Tomography; Breast Cancer; Imaging

Outcome Measures

Primary Outcomes (1)

• Malignant breast cancer detection

  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.

  Pre-treatment

Secondary Outcomes (1)

• Imaging comparison

  Pre-treatment

Study Arms (1)

Newly diagnosed breast cancer

EXPERIMENTAL

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

Interventions

FBnTP DRUG

A PET imaging radiotracer

Also known as: Fluorobenzyl triphenyl phosphonium

Newly diagnosed breast cancer

Eligibility Criteria

• Age: 26 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

18F-fluorobenzyl triphenyl phosphonium

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Martin Pomper, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: July 30, 2014
• Study Start: March 12, 2015
• Primary Completion: December 13, 2021
• Study Completion: December 13, 2021
• Last Updated: December 15, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)