Clinical trial · Interventional
FBnTP Imaging of Breast Cancer
FBnTP Positron Emission Mammography Imaging of Mitochondria Function - Breast Cancer
NCT02204462CI-TRIAL-00055532terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lock of funding
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FBnTP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Newly diagnosed breast cancer
- description
- 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.
- interventionNames
- Drug: FBnTP
Primary outcomes (1)
- measure
- Malignant breast cancer detection
- timeFrame
- Pre-treatment
- description
- 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 outcomes (1)
- measure
- Imaging comparison
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 26 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.