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NCT01864083 · ClinicalTrials.gov registry record · Early Phase 1
FACBC PET and PEM as a Staging Tool and Indicator of Therapeutic Response in Breast Cancer Patients
A Early Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
NCT01864083: Completed Early Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT01864083 is a Early Phase 1 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 30 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01864083, a Early Phase 1 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Accuracy of standardized uptake values will be analyzed by receiver operating characteristic (ROC) curves. ROC curves will be constructed separately for FACBC PET, FACBC PEM and MR. The area under the curve will be used as a summary measure and compared using the standard nonparametric test \[20\]. We will also consider dichotomizing the uptake and present accuracy using sensitivity, specificity and predictive values. Dichotomized values will be compared using the McNemar test.
Interventions
- 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2013-05 |
| Est. Completion | 2017-08-29 |
| Phase | Early Phase 1 |
What the finished NCT01864083 record still lists
NCT01864083 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 4 interventions - of which Positron Emission Tomography (PET) is the first listed.
NCT01864083 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01864083 about?
NCT01864083 is a clinical study titled "FACBC PET and PEM as a Staging Tool and Indicator of Therapeutic Response in Breast Cancer Patients". 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.
What is the current status of trial NCT01864083?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2013-05. Estimated completion is 2017-08-29.
What interventions are being tested in trial NCT01864083?
The interventions under investigation include: Positron Emission Tomography (PET) (PROCEDURE), Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC) (DRUG), Positron emission mammography (PEM) When available (PROCEDURE), MR (PROCEDURE).
Who is sponsoring clinical trial NCT01864083?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01864083's enrollment target sits among peer trials
30 807th of 2000 higher than 1,075 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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