Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549478
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Biology-Guided Radiation Therapy for the Treatment of Patients with Bone Metastases
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Study of BgRT for Bone Metastases
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate pain response by 14 gray Gy single fraction SF-BgRT for patients with painful bone metastases
SECONDARY OBJECTIVE
I To evaluate patient-reported health related quality of life QOL clinician-rated toxicity per Common Terminology Criteria for Adverse Events CTCAE version v 50 radiographic evidence of disease progression at treated sites and rate of re-irradiation
OUTLINE
Patients undergo a single fraction of BgRT on day 0 Patients undergo positron emission tomography PETcomputed tomography CT on study and optionally during follow up
After completion of study treatment patients are followed up at 2 weeks 3 months and then every 3 months for up to 1 year
I To evaluate pain response by 14 gray Gy single fraction SF-BgRT for patients with painful bone metastases
SECONDARY OBJECTIVE
I To evaluate patient-reported health related quality of life QOL clinician-rated toxicity per Common Terminology Criteria for Adverse Events CTCAE version v 50 radiographic evidence of disease progression at treated sites and rate of re-irradiation
OUTLINE
Patients undergo a single fraction of BgRT on day 0 Patients undergo positron emission tomography PETcomputed tomography CT on study and optionally during follow up
After completion of study treatment patients are followed up at 2 weeks 3 months and then every 3 months for up to 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None