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NCT01543659 · ClinicalTrials.gov registry record · Phase 1
Clinical and Molecular Correlates of Positron Emission Tomography (PET) With 89Zr-DFO-huJ591 in Metastatic Prostate Cancer
A Phase 1 study of Prostate Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 77
- Enrollment target
- 1
- Study location
NCT01543659: Completed Phase 1 study of Prostate Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT01543659 is a Phase 1 study of Prostate Cancer that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 77 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01543659, a Phase 1 study of Prostate Cancer, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 77 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to define the safety and accuracy of 89Zr-DFO-huJ591 PET scans. By improving our ability to find cancer cells, the investigators hope to be able to improve treatment for patients in the future. The study doctors want to determine whether a new kind of scan, called a 89Zr-DFO-huJ591 PET scan, can specifically see prostate cancer that has spread to other parts of the body, especially the bones. The study doctors will also look at how the 89Zr-DFO-huJ591 reacts with the body and how long it stays in the body. The investigators will also ask the patient to have a biopsy performed. The study doctors will compare the findings the investigators see on the scans with findings on the optional tissue biopsy. Finally, the investigators will compare the pictures from a 89Zr-DFO-huJ591 PET scan with those of a standard PET scan (called FDG PET) and standard CT scans or magnetic resonance (MRI) scans or bone scans, depending on which standard scans the doctor has ordered. PET scanning uses a small amount of radiation attached to a molecule that is taken up by the cancer. In this trial, the patient will undergo two types of PET scans. One uses FDG. FDG is a standard tracer for PET scans. The patient will also undergo another type of PET scan that is experimental. This experimental PET uses a radioactive protein called J591. The radiation source is a type of metal called zirconium-89 (89Zr). The whole tracer, J591 plus the 89Zr, is abbreviated as 89Zr-DFO-huJ591. This tracer is what is being studied. The tracer used in a scan should find where the cancer is in the body.
Primary Outcome
With 50 patients enrolled over 3 years and an anticipated 20 lesions per patient, our estimate of sensitivity will be based on approximately 1000 lesions. Assuming an intra-patient correlation of 0.1 (based on our experience of FDG PET in this disease) we will be able to estimate the sensitivity within ±9% of its true value, assuming that the true sensitivity is 50%. If the sensitivity is higher then our estimates will be more precise. The findings from the optimal scan of 89Zr-DFO-huJ591 PET in
Conditions Studied
Interventions
- DRUG 89Zr-DFO-huJ591
Study Locations (1)
New York
- Memorial Sloan-Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2012-02-21 |
| Est. Completion | 2026-02-10 |
| Phase | Phase 1 |
What the finished NCT01543659 record still lists
NCT01543659 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which 89Zr-DFO-huJ591 is the first listed.
NCT01543659 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01543659 about?
NCT01543659 is a clinical study titled "Clinical and Molecular Correlates of Positron Emission Tomography (PET) With 89Zr-DFO-huJ591 in Metastatic Prostate Cancer". The purpose of this study is to define the safety and accuracy of 89Zr-DFO-huJ591 PET scans. By improving our ability to find cancer cells, the investigators hope to be able to improve treatment for patients in the future. The study doctors want to determine whether a new kind of scan, called a 89Z...
What is the current status of trial NCT01543659?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 77 participants. The study started on 2012-02-21. Estimated completion is 2026-02-10.
What conditions does trial NCT01543659 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT01543659?
The interventions under investigation include: 89Zr-DFO-huJ591 (DRUG).
Who is sponsoring clinical trial NCT01543659?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01543659 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01543659's enrollment target sits among peer trials
77 385th of 735 higher than 349 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
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