Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524778
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Single High-dose Brachytherapy for Giant Osteosarcoma Masses
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Therapeutic Effect of Single High-dose Brachytherapy for Locally Inoperable and Metastatic Giant Osteosarcoma Masses
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 study is a prospective single-arm phase II single-center study Patients with locally unresectable giant osteosarcoma masses who meet the criteria are enrolled in the experimental group and all patients receive a single dose of 10Gy of implantable brachytherapy Record treatment-related acute events during and after treatment Follow up on survival and local control after treatment ends marking the end of the trial treatment
Detailed Description:
Screening period Local MRI or CT examination blood routine and coagulation function test
Selected treatment period All enrolled patients received one dose of close range interstitial radiotherapy with a radiation dose of 10 Gy The number of insertion needles depends on the size and location of the tumor The instrument used for radiotherapy is the Medda high-dose rate brachytherapy machine and the radiation source is 192 iridium Record treatment related acute events such as bleeding during the treatment period
Follow up Follow up with local MRI or CT at 1 month 3 months 6 months and 1 year after the end of radiotherapy treatment to evaluate the treatment effect Simultaneously follow up with patients for survival and treatment related adverse reactions such as dermatitis infections etc
Selected treatment period All enrolled patients received one dose of close range interstitial radiotherapy with a radiation dose of 10 Gy The number of insertion needles depends on the size and location of the tumor The instrument used for radiotherapy is the Medda high-dose rate brachytherapy machine and the radiation source is 192 iridium Record treatment related acute events such as bleeding during the treatment period
Follow up Follow up with local MRI or CT at 1 month 3 months 6 months and 1 year after the end of radiotherapy treatment to evaluate the treatment effect Simultaneously follow up with patients for survival and treatment related adverse reactions such as dermatitis infections etc
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