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NCT00179907 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Study of the Photon Radiosurgery System
A Phase 1 study, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT00179907: Completed Phase 1 study, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
NCT00179907 is a Phase 1 study that has completed, run by Ann & Robert H Lurie Children's Hospital of Chicago. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00179907, a Phase 1 study, has completed, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
The standard treatment for children with brain tumors is surgical removal of the tumor followed by radiation to the brain and chemotherapy (medicines) given to shrink any remaining tumor or to prevent tumor from growing back. There are very few treatment options available for children whose brain tumor grows back after receiving radiation treatment. There is a greater risk of complications and side effects when the brain is repeatedly treated with external radiation. The side effects of repeat radiation treatment are dependent on the amount of the brain that is radiated. Radiation given with PRS during surgery is focused to the specific area of the brain where the tumor is located. Therefore, the area of the brain affected by the radiation is smaller. It is hoped that this targeted radiation will lessen the side effects to the normal brain that is not affected by the tumor. It is also hoped that a lower occurrence of side effects will increase the quality of life of children with brain tumors. The optimal dose of targeted radiation is not known. Therefore, increasing doses will be given to treat different patients, starting with the lowest possible dose. The amount of radiation to be given will depend on whether or not your child received prior radiation therapy and where the tumor is located. The groups of patients will first be divided into 2 groups: Group A, who are those who received radiation as part of their prior treatment, and Group B, who are those who did not receive any radiation treatment. Each group will be then divided again into 2 groups depending on the location of the tumor. In each group, if the lowest dose is well-tolerated with only minimal side effects by 3 patients, then the next higher dose will be given to the next 3 patients. The purposes of this research are: * To evaluate the potential side effects of a single high dose of x-rays using the Photon Radiosurgery System (PRS) given to a small area of the brain. * To determine the maximum do
Interventions
- PROCEDURE Photon Radiosurgery System (Intrabeam)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2001-05 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
What the finished NCT00179907 record still lists
NCT00179907 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 1 intervention - of which Photon Radiosurgery System (Intrabeam) is the first listed.
NCT00179907 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00179907 about?
NCT00179907 is a clinical study titled "A Phase I/II Study of the Photon Radiosurgery System". The standard treatment for children with brain tumors is surgical removal of the tumor followed by radiation to the brain and chemotherapy (medicines) given to shrink any remaining tumor or to prevent tumor from growing back. There are very few treatment options available for children whose brain tu...
What is the current status of trial NCT00179907?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2001-05. Estimated completion is 2013-12.
What interventions are being tested in trial NCT00179907?
The interventions under investigation include: Photon Radiosurgery System (Intrabeam) (PROCEDURE).
Who is sponsoring clinical trial NCT00179907?
This trial is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00179907's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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