NCT02608216Active, not recruitingPhase 1
[18F]FLT PET/CT in Rb+ Metastatic Breast Cancer
[18F]Fluorothymidine (FLT) PET/CT Imaging in Rb+ Metastatic Breast Cancer Patients Undergoing LEE011 and Weekly Paclitaxel Therapy
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
In this study positron emission tomography (PET/CT) imaging will be used to evaluate proliferative activity in sites of metastatic disease using the investigational radiotracer [18F]fluorothymidine (FLT).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 18 Oct 2015
- Start date
- Nov 2015
- Primary completion date
- Nov 2026
- Lead sponsor
- University of Pennsylvania
- Diseases
- Metastatic breast cancer
- NCT number
- NCT02608216
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From Nov 2015 to the primary completion date, Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
Other
- Females who are pregnant at the time of screening will not be eligible for this study, urine pregnancy test will be performed at screening in women of child-bearing potential.
- Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
- Ineligible for the therapeutic trial UPCC 06115
Who the study is looking for
- At least 18 years of age
- History of histologically or cytologically confirmed breast cancer, any ER, PR or HER2 status is allowed as long as it expresses the Rb protein.
- At least one site of metastatic breast cancer that is outside of the liver and bone that is identified by standard imaging (e.g. CT, MRI, FDG PET/CT, ultrasound, x-ray)
- Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
- Patients must be candidates to receive treatment on the therapeutic trial UPCC06115, a Phase I study of ribociclib (LEE011) and weekly paclitaxel.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pennsylvania Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.