18F-FBnTP Positron Emission Mammography in Detecting Breast Cancer in Patients with Intraductal Breast Cancer

This phase I trial studies how well 18F-FBnTP positron emission mammography works in detecting breast cancer in patients with intraductal breast cancer. 18F-FBnTP positron emission mammography may detect may detect breast lesions with better sensitivity and better specificity.

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)
• 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

PRIMARY OBJECTIVES:

I. A feasibility study to assess the capacity of fluorine F 18 fluorobenzyl triphenyl phosphonium (18F-FBnTP) positron emission mammography (PEM) to detect and localize malignant breast lesions.

SECONDARY OBJECTIVES:

I. To quantify FBnTP tumor uptake and size, and tumor-to-background ratio (TBR).

II To correlate FBnTP PEM results with tumor size, grade and stage, as reported by clinical histopathology.

III. To evaluate the concordance in detecting malignant breast lesions between FBnTP PEM and available diagnostic tests including, mammogram, 18F fludeoxyglucose (18F-FDG) PEM and magnetic resonance imaging (MRI).

OUTLINE:

Patients receive 18F-FBnTP intravenously (IV) and undergo PEM scan over 90 minutes. Patients also receive 18F-FDG IV and undergo PEM scan over 90 minutes.

After completion of study, patients are followed up within 24-48 hours.

Lead Organization
Johns Hopkins University / Sidney Kimmel Cancer Center

Principal Investigator
Martin Pomper

Primary ID J13162
Secondary IDs NCI-2017-01501
Clinicaltrials.gov ID NCT02204462