Clinical trial · Interventional
FACBC PET and PEM as a Staging Tool and Indicator of Therapeutic Response in Breast Cancer Patients
NCT01864083CI-TRIAL-00029369completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study has been designed to help us determine if FACBC PET or PEM can accurately evaluate how far the breast cancer has spread in the breast. Also, to help determine if FACBC PET or PEM can accurately measure your response to chemotherapy.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC) | Drug | — | UNRESOLVED |
| MR | Procedure | — | UNRESOLVED |
| Positron emission mammography (PEM) When available | Procedure | — | UNRESOLVED |
| Positron Emission Tomography (PET) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Local staging patients
- description
- Breast MR and FACBC PET/PEM will be scheduled within one week of each other. Breast MR is a standard clinical examination and will be performed as standard.
- interventionNames
- Procedure: Positron Emission Tomography (PET)
- Drug: Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC)
- Procedure: Positron emission mammography (PEM) When available
- Procedure: MR
- type
- EXPERIMENTAL
- label
- Neoadjuvant chemotherapy patients
- description
- Baseline FACBC PET/PEM will be scheduled within 1 week of beginning neoadjuvant therapy. A repeat FACBC PET/PEM will be scheduled after the conclusion of neoadjuvant therapy, and before definitive surgical management.
- interventionNames
- Procedure: Positron Emission Tomography (PET)
- Drug: Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Women presenting for evaluation at MSKCC with biopsy proven primary IDC or ILC * No prior therapy for IDC or ILC * Clinical need for local disease staging with breast MR (Group A only) * Clinical need for neoadjuvant chemotherapy (Group B only) * Patients must provide written informed consent Exclusion Criteria: * Age \<21 years * Men * Pregnancy or lactation * Patients who have already started treatment for the current malignancy * Patients who cannot undergo PET scanning (i.e. because of weight limits) * Patients who are known to have contraindication for MRI (e.g. metal implants) * Patients may only participate in group #1 or group #2, but not both
References
Publications (1)
- DERIVEDUlaner GA, Goldman DA, Corben A, Lyashchenko SK, Gonen M, Lewis JS, Dickler M. Prospective Clinical Trial of 18F-Fluciclovine PET/CT for Determining the Response to Neoadjuvant Therapy in Invasive Ductal and Invasive Lobular Breast Cancers. J Nucl Med. 2017 Jul;58(7):1037-1042. doi: 10.2967/jnumed.116.183335. Epub 2016 Nov 17. PMID 27856630