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NCT01086696 · ClinicalTrials.gov registry record · Early Phase 1
A Pilot Study of F-18 Paclitaxel (FPAC) PET for Evaluating Drug Delivery of Solid Tumors in Breast, Lung, Renal, and Adrenal Cancers
A Early Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 6
- Enrollment target
NCT01086696: Clinical Trial Early Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01086696 is a Early Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 6 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01086696, a Early Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
Background: * Paclitaxel is a chemotherapy drug that is commonly used to treat different types of cancers. However, cancer tumors can become resistant to paclitaxel, and as a result they will fail to accumulate sufficient concentrations of paclitaxel to kill the cancer cells. Researchers are interested in studying whether tumors have become resistant to paclitaxel, but to do so it must be possible to see how much paclitaxel is absorbed by the tumor cells. * 18F-Fluoropaclitaxel (FPAC) is a form of paclitaxel that has been modified to be slightly radioactive in order to show up on positron emission tomography (PET) scans. By injecting a very small amount (much less that that used to treat tumors) of the radiolabeled drug into the body, researchers hope to use PET scans to evaluate the amount of the drug absorbed by solid tumors. Because FPAC is best used to study tumors located above the diaphragm, all subjects in the study will have tumors near or above the diaphragm. Objectives: \- To determine the safety and effectiveness of FPAC as a radiological evaluation chemical. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with breast, adrenal, renal, or lung cancer and have a tumor located someone in the body at least 1 centimeter above the diaphragm. Design: * Participants will be screened with a physical exam, blood tests, and imaging studies as directed by the study researchers. * Participants will receive a single dose of FPAC, followed by a series of PET scans. Regular scans will be performed for 3 hours after the dose of FPAC. * Participants will also have a single dose of a more conventional radiotracer, followed by a series of PET scans. The results of the two sets of scans will be compared with information from previous imaging studies of participants' tumors.
Interventions
- DRUG FPAC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2010-03-09 |
| Est. Completion | 2016-05-11 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01086696
The ClinicalTrials.gov registry entry for NCT01086696 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which FPAC is the first listed.
NCT01086696 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01086696 about?
NCT01086696 is a clinical study titled "A Pilot Study of F-18 Paclitaxel (FPAC) PET for Evaluating Drug Delivery of Solid Tumors in Breast, Lung, Renal, and Adrenal Cancers". Background: * Paclitaxel is a chemotherapy drug that is commonly used to treat different types of cancers. However, cancer tumors can become resistant to paclitaxel, and as a result they will fail to accumulate sufficient concentrations of paclitaxel to kill the cancer cells. Researchers are intere...
What is the current status of trial NCT01086696?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 6 participants. The study started on 2010-03-09. Estimated completion is 2016-05-11.
What interventions are being tested in trial NCT01086696?
The interventions under investigation include: FPAC (DRUG).
Who is sponsoring clinical trial NCT01086696?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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