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NCT06549478 · ClinicalTrials.gov registry record · Phase 1
Biology-Guided Radiation Therapy for the Treatment of Patients With Bone Metastases
A Phase 1 study of Metastatic Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Bone, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT06549478: Recruiting Phase 1 study of Metastatic Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Bone, sponsored by City of Hope Medical Center.
NCT06549478 is a Phase 1 study of Metastatic Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Bone that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 24 participants, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06549478, a Phase 1 study of Metastatic Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Bone, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This clinical trial tests the safety and effectiveness of a single-dose treatment of biology-guided radiation therapy (BgRT) in treating patients with painful cancer that has spread from where it first started (primary site) to the bone (bone metastases). Bone metastases can result in significant pain and reduction in quality of life. Single fraction radiation therapy (SFRT) can produce equivalent pain relief compared to multi-fraction radiation therapy, but SFRT treatments generally lead to higher rates of retreatment. BgRT is a new and innovative form of radiation delivery that uses a signal generated by positron emission tomography to guide external beam radiation therapy. It is a technology breakthrough that uses live, continuously updated data throughout the entire treatment session to determine exactly where to deliver radiotherapy to biologically active tumors. Giving BgRT may be safe and effective in treating patients with painful bone metastases.
Primary Outcome
Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Toxicity is defined as any ≥ grade 3 gastrointestinal, genitourinary, lung, or skeletomuscular toxicities that is considered at least possibly related to the study treatment and occurs within 3 months after the treatment.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- OTHER Questionnaire Administration
- RADIATION Image Guided Radiation Therapy
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-07-26 |
| Est. Completion | 2027-01-26 |
| Phase | Phase 1 |
What NCT06549478 shows while recruiting
NCT06549478 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 4 interventions - of which Computed Tomography is the first listed.
NCT06549478 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06549478 about?
NCT06549478 is a clinical study titled "Biology-Guided Radiation Therapy for the Treatment of Patients With Bone Metastases". This clinical trial tests the safety and effectiveness of a single-dose treatment of biology-guided radiation therapy (BgRT) in treating patients with painful cancer that has spread from where it first started (primary site) to the bone (bone metastases). Bone metastases can result in significant pa...
What is the current status of trial NCT06549478?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2024-07-26. Estimated completion is 2027-01-26.
What conditions does trial NCT06549478 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Metastatic Malignant Neoplasm in the Bone.
What interventions are being tested in trial NCT06549478?
The interventions under investigation include: Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Questionnaire Administration (OTHER), Image Guided Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT06549478?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06549478 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06549478's enrollment target sits among peer trials
24 82nd of 92 higher than 10 of 92 other Metastatic Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
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